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A Multidisciplinary Approach to Assessing and Treating Fatigue in Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Diseases, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Exercise Intervention
Acceptance and Commitment Therapy
Probiotic
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed diagnosis of inflammatory bowel disease Exclusion Criteria: Pregnant women Patients unable to consent Patients under 18 and over 70 years of age

Sites / Locations

  • St Vincent's University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

No Intervention

No Intervention

Other

Other

Other

Other

Arm Label

Cross Sectional Study to define the extent and severity of fatigue

Treatment for active disease and its effect on fatigue.

The effect of treating anaemia on fatigue in IBD

Assessing exercise therapies in IBD subjects with fatigue

Acceptance and commitment therapy (ACT) in IBD subjects with fatigue

ACT for IBD subjects with sleep disturbance and fatigue

A longitudinal study of probiotics for IBD subjects with fatigue

Arm Description

All patients attending the IBD service that meet inclusion criteria will be given the opportunity to participate in this study. Information will be collected at baseline including demographic data, IBD history and symptoms, co-morbidities and disease activity. Patients will have baseline blood tests taken to assess for causes of fatigue as well as faecal calprotectin to assess for evidence of inflammation. Patients without fatigue will at this point exit the study and will not require any further follow up.

A longitudinal study of contemporary treatment for active disease and its effect on fatigue. Patients with active disease and fatigue will be followed prospectively while undergoing treatment for active IBD with the IBD team. If their fatigue resolves, they will exit the study at this point. If their fatigue persists, they will be further assessed as detailed below.

A longitudinal study assessing anaemia and the effect of treatment on fatigue in those subjects with inactive IBD.Patients with anaemia and fatigue will be followed prospectively while undergoing treatment for anaemia with the IBD team. The study outcomes will be assessed at recruitment and when their anaemia has resolved (this may occur in parallel with the disease activity arm). If their fatigue resolves, they will exit the study at this point. If their fatigue persists, they will be further assessed as detailed below.

A longitudinal study assessing of dietary and exercise therapies for IBD subjects with fatigue using a single case study (SCS) design. They will have their physical activity levels assessed at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with fatigue despite optimisation will be offered a physical activity intervention. Each participant will be assessed initially and subsequently assigned a physical activity intervention with a physical therapist.

A longitudinal study of acceptance and commitment therapy (ACT) in IBD subjects with psychological disability and fatigue using a single case study (SCS) design. All patients will undergo psychological assessment as detailed above at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with fatigue and psychological disability will be referred to the IBD psychology service or recruited to a psychological intervention. Participants will receive an online intervention with a psychologist from the School of Psychology in University College Dublin to address psychological disability and associated fatigue.

A longitudinal study of ACT for IBD subjects with sleep disturbance using a single case study (SCS) design. Patients will have their sleep quality assessed at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with sleep disturbance will undergo sleep studies at home both at the start and end of the intervention. This device will be a non-invasive, widely available sleep device worn on the wrist or the patient's index finger for one to three consecutive nights. They will be referred to the sleep medicine unit in SVUH if sleep apnea or another diagnosis that requires medical intervention is identified. Otherwise they will undergo an online intervention with a psychologist from the School of Psychology in University College Dublin to address their sleep quality.

Participants will have their stool analysed to assess the diversity of their microbiome. They will receive a twelve-week course of a probiotic which will be taken once daily. They will then have their stool re-assessed at the completion of the intervention.

Outcomes

Primary Outcome Measures

Fatigue
The primary outcome is to assess for improvement in fatigue using the Multidimensional Fatigue Index (MFI). This is a 20 item scale; each item is scored 1 to 5 with higher scores indicating higher levels of fatigue. Total score for each participant will range between 20 and 100; with high scores indicating more fatigue.

Secondary Outcome Measures

Physical activity
Assessing changes in activity based on the International Physical Activity Questionnaire (IPAQ). The sum score is expressed in physical activity Metabolic Equivalent of Task (MET)-minutes per day or week. Higher scores indicate higher levels of activity.
Work Productivity and Activity Impairment
Assessing changes in Work Productivity and Activity Impairment Questionnaire (WPAIQ). The score for the WPAIQ is expressed as a percentage. Higher percentages of work and activity impairment indicating worse outcomes.
Physical activity: Grip strength
Assessing changes in grip strength. This is measured in kilograms. Higher grip strength in kilograms indicate better outcomes (values are age dependent).
Physical activity: Power assessment
Assessing changes in squat testing: Time taken for 5 squats in seconds assesses power. The shorter the time, the higher the power.
Physical activity: endurance assessment
Assessing changes in squat testing. The thirty-second sit to stand test will assess endurance. The higher the number of squats performed suggests higher levels of endurance and leg strength.
Physical activity: weight
Assessing changes in weight using bioimpedance analysis as part of the physical assessment. This will be measured in kilograms.
Psychological assessment
Depression, Anxiety and Stress Scale (DASS-21) will be used. Participants will score between 0-63 with higher scores indicating worse outcomes and increased anxiety, depression and stress levels.
Personality assessment
The Big Five Personality Inventory. This measures personality traits using 10 questions measured on a 5 point scale. This is to assess the impact of personality traits on fatigue rather than correlating directly with better or worse outcomes.
Disease related disability and quality of life
IBD Disability index. Scores range from 0-100. Higher scores indicate worse outcomes.
Health related quality of life
Short Health Scale (SHS) is a four part visual analogue scale questionnaire; the scale is marked from 0 to 100mm. Higher scores indicate a negative impact of disease on quality of life.
Sleep quality
Epworth Sleepiness Scale is scored from 0 to 24 with scores above 12 indicating abnormal levels of daytime somnolence.
Body image
Modified Body Image Scale. This scale includes nine items scored 0 to 3. Score ranges from 0 to 27 with higher scores indicating increased body image dissatisfaction.
Nutritional assessment
Malnutrition Universal Screening Tool (MUST). There are three measurements assessed; total score ranges from 0 to 6 with a score above 2 indicating worse outcomes.
Disease activity for participants with Ulcerative Colitis
Partial Mayo score for patients with Ulcerative Colitis (See outcome 16 for the applicable scoring system from participants with Crohns disease). Parameters of disease activity are scored 0 to 3 with a total score range of 0 to 9. Higher scores correlate with higher levels of disease activity.
Disease activity for participants with Crohn's disease
Crohns disease activity index score ranges from 0 to 600. A score of less than 150 indicates disease in remission. Higher scores correlate with higher levels of disease activity.
C-Reactive Protein Concentration: Serum marker of inflammation to assess disease activity
CRP is a serum measurement of inflammation. Normal range is 0-5mg/L. Higher values indicate higher levels of systemic inflammation.
Faecal calprotectin concentration: Stool analysis to assess for disease activity
Faecal calprotectin. This is a measure of disease activity. Values less than 250 micrograms/miligrams indicate disease remission. Higher values indicate disease activity.

Full Information

First Posted
May 24, 2023
Last Updated
June 19, 2023
Sponsor
University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT05906043
Brief Title
A Multidisciplinary Approach to Assessing and Treating Fatigue in Inflammatory Bowel Disease
Official Title
A Multidisciplinary Approach to Assessing and Treating Fatigue in Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
June 24, 2025 (Anticipated)
Study Completion Date
August 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is examining fatigue in patients with Inflammatory Bowel Disease (IBD). IBD includes Ulcerative Colitis (UC) and Crohn's disease. These are inflammatory conditions of the gastrointestinal tract and are associated with symptoms including diarrhoea, rectal bleeding and abdominal pain. Fatigue is a common problem for patents with IBD, affecting 80% of patients with active disease.This study aims to identify all IBD patients with fatigue. Initially, the investigators will address all medical causes of fatigue in line with current practice, using a stepwise approach (e.g. assessing for and treating active inflammation, anaemia as well as electrolyte, hormone and vitamin imbalances). The aim is to treat fatigue using a detailed algorithm, as fatigue is often a consequence of multiple issues in IBD patients. The investigators will assess the role of physical activity, nutritional status and psychological wellbeing in fatigue persisting in medically-optimised IBD patients. In addition, the contribution of the microbiome to fatigue will be assessed. For those in whom these factors are identified alongside persistent fatigue, interventions have been designed to address these factors and the resulting fatigue.
Detailed Description
This is a longitudinal research study to define the extent and severity of fatigue in IBD patients; patients will be followed for a period of weeks to months depending on each individual participants needs. The study will be a cross-sectional in nature initially. The study is open to all mobile and non-pregnant Crohn's disease and ulcerative colitis patients between the ages of 18 and 70 years. Recruitment will take place in St Vincent's University Hospital, an academic teaching hospital, from Gastroenterology clinics as well as through the IBD clinical nurse specialist service. Patients that meet inclusion criteria will be recruited from clinics and/or through the IBD clinical nurse specialist service. The recruited subjects will be briefed on the inclusion and exclusion criteria, the nature of the study as well as the outcome measure. Participants will receive information packs and consent forms. All participants will have the opportunity to withdraw at any stage during the study and this will be explained to them. Patients will be followed up as clinically necessary within the parameters of the study and at the IBD clinic at clinically appropriate intervals. All patients attending the IBD service that meet inclusion criteria will be given the opportunity to participate in this study. Information will be collected at baseline including demographic data, IBD history and symptoms, co-morbidities and disease activity. There are seven elements to this study that will be carried out in parallel: An initial cross-sectional study to define the extent and severity of fatigue in IBD subjects incorporating a simple fitness test protocol. All patients attending the IBD service that meet inclusion criteria will be given the opportunity to participate in this study. Information will be collected at baseline including demographic data, IBD history and symptoms, co-morbidities and disease activity. Patients will have baseline blood tests taken to assess for causes of fatigue as well as faecal calprotectin to assess for evidence of inflammation. Patients without fatigue will at this point exit the study and will not require any further follow up. In those with fatigue, disease activity will be assessed and treated in accordance with current clinical guidelines (as would be standard of care). Fatigued patients will also be assessed for anaemia and other medical causes of fatigue and treated for these as per current clinical practice guidelines. A longitudinal study of contemporary treatment for active disease and its effect on fatigue. Patients with active disease and fatigue will be followed prospectively while undergoing treatment for active IBD with the IBD team. Each patient's response to treatment will vary and so the exact time point between disease treatment and resolution of disease activity cannot be clearly defined. The study outcomes will be assessed at recruitment and when participants achieve clinical and biochemical remission. If fatigue resolves, participants will exit the study at this point. If fatigue persists, further assessments will take place as detailed below. A longitudinal study assessing anaemia and the effect of treatment on fatigue in those subjects with inactive IBD. Patients with anaemia and fatigue will be followed prospectively while undergoing treatment for anaemia with the IBD team. Each patient's response to treatment will vary and so the exact time point between anaemia treatment and resolution of anaemia cannot be clearly defined. The study outcomes will be assessed at recruitment and when anaemia has resolved (this may occur in parallel with the disease activity arm). If fatigue resolves, participants will exit the study at this point. If fatigue persists, further assessments will take place as detailed below. A longitudinal study assessing of dietary and exercise therapies for IBD subjects using a single case study (SCS) design. Participants will also have physical activity levels assessed at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. These assessments will take place on site in St Vincent's University Hospital. If fatigue resolves, participants will exit the study at this point. Those with fatigue despite optimizing nutrition will be offered a physical activity intervention. The time interval between recruitment and resolution of micronutrient deficiencies will vary from patient to patient and so the exact time interval cannot be specified. Each participant will be assessed initially and subsequently assigned a physical activity intervention with a physical therapist designed by the Department of Sports Medicine, University College Dublin. A longitudinal study of acceptance and commitment therapy (ACT) in IBD subjects with psychological disability using a single case study (SCS) design. All patients will undergo psychological assessment as detailed above at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with fatigue and psychological disability will be referred to the IBD psychology service or recruited to a psychological intervention. Participants will receive an intervention with a psychologist from the School of Psychology in University College Dublin to address psychological disability and associated fatigue. A longitudinal study of ACT for IBD subjects with sleep disturbance using a single case study (SCS) design. Patients will have sleep quality assessed at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with sleep disturbance will undergo sleep studies at home both at the start and end of the intervention. This device will be a non-invasive, widely available sleep device worn on the wrist or the patient's index finger for one to three consecutive nights. Participants will be referred to the sleep medicine unit in SVUH if sleep apnea or another diagnosis that requires medical intervention is identified. Otherwise participants will undergo an intervention with a psychologist from the School of Psychology in University College Dublin to address sleep quality. A longitudinal study of probiotics for IBD subjects with fatigue. Participants will have stool samples analysed to assess the microbiome diversity. A twelve-week course of a probiotic which will be taken once daily will then be provided. Stool will be re-assessed at the completion of the intervention. Each of the four treatment arms will be treated as multiple baseline single case experimental design (SCED). Thus, each participant is treated as an individual study. This type of study provides evidence for the effectiveness of interventions with much fewer participants than group average-based designs such as Randomized Controlled Trials. Standard group-based designs may find an overall treatment benefit on average but may underestimate risks, ineffectiveness, and benefits to the individual. Each participant will receive a follow up phone call after the intervention is complete, to identify any challenges integrating skills discussed during the interventions. Completion of an online questionnaire will be required at the end of the study period, in order to assess the primary and secondary outcomes. Any participants with ongoing fatigue will be able to opt to participate in the remaining treatment arms if needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cross sectional study, with observational elements and four interventions utilising a single case experimental design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cross Sectional Study to define the extent and severity of fatigue
Arm Type
No Intervention
Arm Description
All patients attending the IBD service that meet inclusion criteria will be given the opportunity to participate in this study. Information will be collected at baseline including demographic data, IBD history and symptoms, co-morbidities and disease activity. Patients will have baseline blood tests taken to assess for causes of fatigue as well as faecal calprotectin to assess for evidence of inflammation. Patients without fatigue will at this point exit the study and will not require any further follow up.
Arm Title
Treatment for active disease and its effect on fatigue.
Arm Type
No Intervention
Arm Description
A longitudinal study of contemporary treatment for active disease and its effect on fatigue. Patients with active disease and fatigue will be followed prospectively while undergoing treatment for active IBD with the IBD team. If their fatigue resolves, they will exit the study at this point. If their fatigue persists, they will be further assessed as detailed below.
Arm Title
The effect of treating anaemia on fatigue in IBD
Arm Type
No Intervention
Arm Description
A longitudinal study assessing anaemia and the effect of treatment on fatigue in those subjects with inactive IBD.Patients with anaemia and fatigue will be followed prospectively while undergoing treatment for anaemia with the IBD team. The study outcomes will be assessed at recruitment and when their anaemia has resolved (this may occur in parallel with the disease activity arm). If their fatigue resolves, they will exit the study at this point. If their fatigue persists, they will be further assessed as detailed below.
Arm Title
Assessing exercise therapies in IBD subjects with fatigue
Arm Type
Other
Arm Description
A longitudinal study assessing of dietary and exercise therapies for IBD subjects with fatigue using a single case study (SCS) design. They will have their physical activity levels assessed at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with fatigue despite optimisation will be offered a physical activity intervention. Each participant will be assessed initially and subsequently assigned a physical activity intervention with a physical therapist.
Arm Title
Acceptance and commitment therapy (ACT) in IBD subjects with fatigue
Arm Type
Other
Arm Description
A longitudinal study of acceptance and commitment therapy (ACT) in IBD subjects with psychological disability and fatigue using a single case study (SCS) design. All patients will undergo psychological assessment as detailed above at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with fatigue and psychological disability will be referred to the IBD psychology service or recruited to a psychological intervention. Participants will receive an online intervention with a psychologist from the School of Psychology in University College Dublin to address psychological disability and associated fatigue.
Arm Title
ACT for IBD subjects with sleep disturbance and fatigue
Arm Type
Other
Arm Description
A longitudinal study of ACT for IBD subjects with sleep disturbance using a single case study (SCS) design. Patients will have their sleep quality assessed at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with sleep disturbance will undergo sleep studies at home both at the start and end of the intervention. This device will be a non-invasive, widely available sleep device worn on the wrist or the patient's index finger for one to three consecutive nights. They will be referred to the sleep medicine unit in SVUH if sleep apnea or another diagnosis that requires medical intervention is identified. Otherwise they will undergo an online intervention with a psychologist from the School of Psychology in University College Dublin to address their sleep quality.
Arm Title
A longitudinal study of probiotics for IBD subjects with fatigue
Arm Type
Other
Arm Description
Participants will have their stool analysed to assess the diversity of their microbiome. They will receive a twelve-week course of a probiotic which will be taken once daily. They will then have their stool re-assessed at the completion of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Exercise intervention
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
ACT will be used for patients with psychological disability as well as for those with sleep disturbance
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Use of a probiotic
Primary Outcome Measure Information:
Title
Fatigue
Description
The primary outcome is to assess for improvement in fatigue using the Multidimensional Fatigue Index (MFI). This is a 20 item scale; each item is scored 1 to 5 with higher scores indicating higher levels of fatigue. Total score for each participant will range between 20 and 100; with high scores indicating more fatigue.
Time Frame
Dependent on the factors involved; this will be different for each participant (up to 24 months)
Secondary Outcome Measure Information:
Title
Physical activity
Description
Assessing changes in activity based on the International Physical Activity Questionnaire (IPAQ). The sum score is expressed in physical activity Metabolic Equivalent of Task (MET)-minutes per day or week. Higher scores indicate higher levels of activity.
Time Frame
Intervention will take place over 12 weeks
Title
Work Productivity and Activity Impairment
Description
Assessing changes in Work Productivity and Activity Impairment Questionnaire (WPAIQ). The score for the WPAIQ is expressed as a percentage. Higher percentages of work and activity impairment indicating worse outcomes.
Time Frame
Intervention will take place over 12 weeks
Title
Physical activity: Grip strength
Description
Assessing changes in grip strength. This is measured in kilograms. Higher grip strength in kilograms indicate better outcomes (values are age dependent).
Time Frame
Intervention will take place over 12 weeks
Title
Physical activity: Power assessment
Description
Assessing changes in squat testing: Time taken for 5 squats in seconds assesses power. The shorter the time, the higher the power.
Time Frame
Intervention will take place over 12 weeks
Title
Physical activity: endurance assessment
Description
Assessing changes in squat testing. The thirty-second sit to stand test will assess endurance. The higher the number of squats performed suggests higher levels of endurance and leg strength.
Time Frame
Intervention will take place over 12 weeks
Title
Physical activity: weight
Description
Assessing changes in weight using bioimpedance analysis as part of the physical assessment. This will be measured in kilograms.
Time Frame
Intervention will take place over 12 weeks
Title
Psychological assessment
Description
Depression, Anxiety and Stress Scale (DASS-21) will be used. Participants will score between 0-63 with higher scores indicating worse outcomes and increased anxiety, depression and stress levels.
Time Frame
Intervention will take place over 12 weeks
Title
Personality assessment
Description
The Big Five Personality Inventory. This measures personality traits using 10 questions measured on a 5 point scale. This is to assess the impact of personality traits on fatigue rather than correlating directly with better or worse outcomes.
Time Frame
Intervention will take place over 12 weeks
Title
Disease related disability and quality of life
Description
IBD Disability index. Scores range from 0-100. Higher scores indicate worse outcomes.
Time Frame
Dependent on the factors involved; this will be different for each participant (up to 24 months)
Title
Health related quality of life
Description
Short Health Scale (SHS) is a four part visual analogue scale questionnaire; the scale is marked from 0 to 100mm. Higher scores indicate a negative impact of disease on quality of life.
Time Frame
Dependent on the factors involved; this will be different for each participant (up to 24 months)
Title
Sleep quality
Description
Epworth Sleepiness Scale is scored from 0 to 24 with scores above 12 indicating abnormal levels of daytime somnolence.
Time Frame
Intervention will take place over 12 weeks
Title
Body image
Description
Modified Body Image Scale. This scale includes nine items scored 0 to 3. Score ranges from 0 to 27 with higher scores indicating increased body image dissatisfaction.
Time Frame
Dependent on the factors involved; this will be different for each participant (up to 24 months)
Title
Nutritional assessment
Description
Malnutrition Universal Screening Tool (MUST). There are three measurements assessed; total score ranges from 0 to 6 with a score above 2 indicating worse outcomes.
Time Frame
Dependent on the factors involved; this will be different for each participant (up to 24 months)
Title
Disease activity for participants with Ulcerative Colitis
Description
Partial Mayo score for patients with Ulcerative Colitis (See outcome 16 for the applicable scoring system from participants with Crohns disease). Parameters of disease activity are scored 0 to 3 with a total score range of 0 to 9. Higher scores correlate with higher levels of disease activity.
Time Frame
Dependent on the factors involved; this will be different for each participant (up to 24 months)
Title
Disease activity for participants with Crohn's disease
Description
Crohns disease activity index score ranges from 0 to 600. A score of less than 150 indicates disease in remission. Higher scores correlate with higher levels of disease activity.
Time Frame
Dependent on the factors involved; this will be different for each participant (up to 24 months)
Title
C-Reactive Protein Concentration: Serum marker of inflammation to assess disease activity
Description
CRP is a serum measurement of inflammation. Normal range is 0-5mg/L. Higher values indicate higher levels of systemic inflammation.
Time Frame
Dependent on the factors involved; this will be different for each participant (up to 24 months)
Title
Faecal calprotectin concentration: Stool analysis to assess for disease activity
Description
Faecal calprotectin. This is a measure of disease activity. Values less than 250 micrograms/miligrams indicate disease remission. Higher values indicate disease activity.
Time Frame
Dependent on the factors involved; this will be different for each participant (up to 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of inflammatory bowel disease Exclusion Criteria: Pregnant women Patients unable to consent Patients under 18 and over 70 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne M Fennessy, MB BCh BAO
Phone
0035312214711
Email
anne.fennessy@ucdconnect.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Hugh Mulcahy, MD FRCPI
Phone
0035312214711
Email
hemulc@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Mulcahy, MD FRCPI
Organizational Affiliation
St Vincent's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Vincent's University Hospital
City
Dublin 4
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Fennessy, MB BCh BAO
Phone
0035312214711
Email
anne.fennessy@ucdconnect.ie

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data will be anonymised in accordance with EU Data Protection legislation. Anonymised data will be available upon request.
Citations:
PubMed Identifier
28749985
Citation
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Results Reference
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PubMed Identifier
17465453
Citation
Minderhoud IM, Samsom M, Oldenburg B. Crohn's disease, fatigue, and infliximab: is there a role for cytokines in the pathogenesis of fatigue? World J Gastroenterol. 2007 Apr 14;13(14):2089-93. doi: 10.3748/wjg.v13.i14.2089.
Results Reference
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PubMed Identifier
20456309
Citation
van Langenberg DR, Gibson PR. Systematic review: fatigue in inflammatory bowel disease. Aliment Pharmacol Ther. 2010 Jul;32(2):131-43. doi: 10.1111/j.1365-2036.2010.04347.x. Epub 2010 May 6.
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21674713
Citation
Jelsness-Jorgensen LP, Bernklev T, Henriksen M, Torp R, Moum BA. Chronic fatigue is more prevalent in patients with inflammatory bowel disease than in healthy controls. Inflamm Bowel Dis. 2011 Jul;17(7):1564-72. doi: 10.1002/ibd.21530. Epub 2010 Nov 8.
Results Reference
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Links:
URL
https://www.crohnscolitisfoundation.org/pain-and-fatigue/fatigue-causes
Description
Crohn's & Colitis Foundation. 2022. IBD and Fatigue.

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A Multidisciplinary Approach to Assessing and Treating Fatigue in Inflammatory Bowel Disease

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