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A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome (PERCEPTIvE)

Primary Purpose

Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Crohn Disease

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ESM and Traqq
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Experience Sampling Method, Traqq

Eligibility Criteria

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

Inclusion criteria IBS patients A diagnosis of IBS according to Rome IV criteria, as follows: Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: Related to defecation; Associated with a change in stool frequency; oAssociated with a change in stool form (appearance). Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. Minimal baseline score of 150 points on the IBS-SSS scale Age between 18 and 70 years; Ability to understand and speak the Dutch language Ability to understand how to utilize the ESM and Traqq applications. Inclusion criteria IBD patients Patients with IBD diagnosed in accordance with current ECCO guidelines, with IBD- IBS and with chronic abdominal pain, as follows: MIAH score <3 Fecal calprotectin < 150 ug/g Fulfilling the Rome IV criteria for IBS. Age between 18 and 70 years; Minimal baseline score of 150 points on the IBS-SSS scale Ability to understand and speak the Dutch language Ability to understand how to utilize the ESM and Traqq applications. Exclusion criteria IBS patients Any organic explanation for the abdominal symptoms; A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present; Pregnant or lactating at the baseline visit. Exclusion criteria IBD patients Uncertainty about the absence of active inflammation Uncertainty about other explanatory causes for the GI symptoms, such as bile acid malabsorption, intestinal stenosis, or small intestinal bacterial overgrowth; Pregnant or lactating at the baseline visit.

Sites / Locations

  • Maastricht UMC+Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ESM/Traqq

Standard care

Arm Description

Use of ESM and Traqq for one week to get a personalised analysis of the abdominal pain and triggerfactors that can be used at the outpatient clinic visit to select an effective treatment option.

Will not be using ESM and Traqq, but will only get a standard outpatient clinic visit together with PDSkeuzehulp to make a decision for a treatment.

Outcomes

Primary Outcome Measures

Irritable Bowel Syndrome- Symptom Severity Score (IBS-SSS)
Change in IBS-SSS to see whether IBS symptoms are improved Scale 0-500 A higher score means worse outcome

Secondary Outcome Measures

General Anxiety Disorder-7 (GAD-7)
Change in GAD-7 to see whether complaints of anxiety are improved Scale 0-21 A higher score means worse outcome
Multidimensional Fatigue Inventory-20 (MFI-20)
Change in MFI-20 to see whether fatigue is improved Scale 20-100 A higher score means worse outcome
Patient Health Questionnaire-9 (PHQ-9)
Change in PHQ-9 to see whether complaints of depression are improved Scale 0-27 A higher score means worse outcome
Visceral Sensitivity Index (VSI)
Change in VSI to see whether complaints of GI related anxiety are improved Scale 0-75 A higher score means worse outcome
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Change in EQ-5D-5L to see whether quality of life is improved Scale 5-25 A higher score means worse outcome

Full Information

First Posted
August 11, 2023
Last Updated
October 3, 2023
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05998577
Brief Title
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome
Acronym
PERCEPTIvE
Official Title
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome and Inflammatory Bowel Disease Using Experience Sampling Method (ESM) and a Digital Food Diary (Traqq)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2023 (Actual)
Primary Completion Date
May 19, 2025 (Anticipated)
Study Completion Date
May 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Apart from its use to provide insight in IBS disease courses and in clinical research, ESM can provide patients with feedback about individual triggers of their symptoms, and thereby function as part of a personalized therapeutic strategy. This is also true for IBD-IBS. Treatment strategies in IBS and IBD-IBS are largely based on reassurance, identification and elimination of triggering factors, and in more severe cases pharmaco- and psychotherapy. The ESM approach has the potential to increase therapeutic efficacy in IBS and IBD-IBS and will assist patients in disease self-management. The Traqq application can provide more detailed information about the dietary pattern of IBS and IBD-IBS patients. Traqq in combination with ESM will give an overview of abdominal pain and associated symptoms and psychosocial factors are exposed to during the day. The insight provided using ESM and Traqq may improve patient understanding of their personal symptom dynamics and triggers, as well as the physician's insight into the symptom patters of the specific patients, which may aid treatment choice and eventually improve the outcome of any treatment provided in daily clinical care.
Detailed Description
This is an unicenter, prospective, proof-of-concept randomized controlled, non-blinded intervention study that focuses on two patient populations, with overlapping symptom patterns and treatment approaches, i.e. patients with IBS and IBD-IBS. Following written informed consent, the eligibility screening is performed and instructions about the study procedures will be given. Hereafter, both groups will independently be randomized into i) an ESM/Traqq arm or ii) a standard care arm. The intervention group and the control group will complete the IBS-SSS, EO-5D-5L, GAD-7, PHQ-9, VSI, and MFl-20 as well as the Rome IV criteria for IBS and functional dyspepsia at baseline and the intervention group will complete thereafter the ESM and Traqq applications during the first week. After this week, the data will be analysed to identify associations between abdominal pain and psychosocial factors, diet or other GI associated symptoms. About two weeks later, participants will have their second visitation at the outpatient clinic with their treating physician. In the intervention group, but not the control group, the patient and the treating physician will receive the results of the personal data of the patients based on ESM and Traqq. The insight participants and their physicians get from this information, will help them to make changes in lifestyle factors that affect their symptoms or to choose a pharmacological or non-pharmacological treatment. However, the study protocol will not indicate which treatment choice should be made by the patient and their treating physicians. That choice will still be based on shared decision making, just as in the standard care arm, only with the additional data provided. Furthermore, if the patients are referred to a dietician, psychologist, or both, the digital data obtained in the intervention group can be used to personalize the therapy. After giving informed consent by the participant for the data of ESM and Traqq being sent to the dietician or psychologist they are referred to, the coordinating investigator will send the data digitally to the dietician or psychologist that is needed for the personalized treatment. Participants in the control arm will get a consultation with the gastroenterologist as usual after the same period of time as the intervention group get their consultation. The participants of the control group will be given treatment advice only based on this consultation, the PDSkeuzehulp by shared decision making, according to standard care. Twelve weeks after the second outpatient visit, independently of the chosen treatment approach, the participants in both study groups will be asked to complete IBS-SSS, EQ-5D-5L, GAD-7, PHO-9, VSI, MFI-20 and Rome IV criteria for IBS and functional dyspepsia for the second time to evaluate whether there is an effect on 1) reduction of abdominal pain and 2) quality of life, psychological aspects or fatigue of the participants due to the insight provided by ESM and Traqq. After those twelve weeks, the coordinating investigator will contact the participants of the intervention group and control group by phone for the last time. Participants are asked what treatment they have gotten and what lifestyle modifications they have done to reduce abdominal pain. To improve compliance for completing the questionnaires by the control group, the participants in the control group will get the opportunity to use the ESM and Traqq applications after the study has been completed. This will not be part of this study but can be beneficial for those individuals who have not got any additional insight about their symptoms by getting the standard care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Functional Gastrointestinal Disorders, Lifestyle Factors
Keywords
Experience Sampling Method, Traqq

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESM/Traqq
Arm Type
Experimental
Arm Description
Use of ESM and Traqq for one week to get a personalised analysis of the abdominal pain and triggerfactors that can be used at the outpatient clinic visit to select an effective treatment option.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Will not be using ESM and Traqq, but will only get a standard outpatient clinic visit together with PDSkeuzehulp to make a decision for a treatment.
Intervention Type
Device
Intervention Name(s)
ESM and Traqq
Intervention Description
Two telephone applications: ESM is a psychosocial diary and Traqq is a food diary to measure abdominal pain as well as possible triggerfactors (i.e. diet, stress, anxiety)
Primary Outcome Measure Information:
Title
Irritable Bowel Syndrome- Symptom Severity Score (IBS-SSS)
Description
Change in IBS-SSS to see whether IBS symptoms are improved Scale 0-500 A higher score means worse outcome
Time Frame
12 weeks after outpatient clinic visit
Secondary Outcome Measure Information:
Title
General Anxiety Disorder-7 (GAD-7)
Description
Change in GAD-7 to see whether complaints of anxiety are improved Scale 0-21 A higher score means worse outcome
Time Frame
12 weeks after outpatient clinic visit
Title
Multidimensional Fatigue Inventory-20 (MFI-20)
Description
Change in MFI-20 to see whether fatigue is improved Scale 20-100 A higher score means worse outcome
Time Frame
12 weeks after outpatient clinic visit
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
Change in PHQ-9 to see whether complaints of depression are improved Scale 0-27 A higher score means worse outcome
Time Frame
12 weeks after outpatient clinic visit
Title
Visceral Sensitivity Index (VSI)
Description
Change in VSI to see whether complaints of GI related anxiety are improved Scale 0-75 A higher score means worse outcome
Time Frame
12 weeks after outpatient clinic visit
Title
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Description
Change in EQ-5D-5L to see whether quality of life is improved Scale 5-25 A higher score means worse outcome
Time Frame
12 weeks after outpatient clinic visit

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 IBS patients A diagnosis of IBS according to Rome IV criteria, as follows: Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: Related to defecation; Associated with a change in stool frequency; oAssociated with a change in stool form (appearance). Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. Minimal baseline score of 150 points on the IBS-SSS scale Age between 18 and 70 years; Ability to understand and speak the Dutch language Ability to understand how to utilize the ESM and Traqq applications. Inclusion criteria IBD patients Patients with IBD diagnosed in accordance with current ECCO guidelines, with IBD- IBS and with chronic abdominal pain, as follows: MIAH score <3 Fecal calprotectin < 150 ug/g Fulfilling the Rome IV criteria for IBS. Age between 18 and 70 years; Minimal baseline score of 150 points on the IBS-SSS scale Ability to understand and speak the Dutch language Ability to understand how to utilize the ESM and Traqq applications. Exclusion criteria IBS patients Any organic explanation for the abdominal symptoms; A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present; Pregnant or lactating at the baseline visit. Exclusion criteria IBD patients Uncertainty about the absence of active inflammation Uncertainty about other explanatory causes for the GI symptoms, such as bile acid malabsorption, intestinal stenosis, or small intestinal bacterial overgrowth; Pregnant or lactating at the baseline visit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daan Bosch, BSc
Phone
0433-884295
Email
daan.bosch@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Zlatan Mujagic, MD, PhD
Phone
0433-875021
Email
z.mujagic@maastrichtuniversity.nl
Facility Information:
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daan Bosch, BSc
Phone
0433-884295
Email
daan.bosch@maastrichtuniversity.nl
First Name & Middle Initial & Last Name & Degree
Zlatan Mujagic, MD, PhD
Phone
0433-875021
Email
z.mujagic@maastrichtuniversity.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All research data will be saved as an SPSS file with all available metadata such as variables, value labels and definitions of missing data in accordance with the existing codebooks. In addition, the research data will be saved as csv files. After completion of the study, the data will be archived and the data will be stored in accordance with the required format of the relevant data archive.

Learn more about this trial

A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome

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