Back to resultsEffects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients
Primary Purpose
Irritable Bowel Syndrome (IBS)
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
HMO1
HMO2
Dextropur
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome (IBS)
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent
- Age between 18 and 75 years at visit 2
- Fulfills definition of IBS-D, IBS-C or IBS-A/M according to Rome IV criteria
- Have a global IBS-SSS score of >174 during the 2 weeks run-in period
- Read, speak and understand Swedish
- Ability and willingness to understand and comply with the study procedures
Exclusion Criteria:
- Participation in a clinical intervention trial one month prior to screening visit and throughout the study.
Any known gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator; in particular
- lactose intolerance
- coeliac disease
- Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
- Severe psychiatric disease and/or psychological disturbance, as judged by the investigator.
- Use of highly dosed probiotic supplements (yoghurt allowed) one month prior to the study and throughout the study. Excluded products are (i) probiotic supplements in the form of capsules, tablets, and powders in sachets, and (ii) probiotic food and drink products which contain high doses of probiotics. The excluded food and drink products are available in the form of yoghurts, drinking yoghurts, shots and drinks under brands such as Proviva, Actimel, Activia, Wellness, and Verum.
- Consumption of antibiotic drugs one month prior to screening and throughout the study. Antibiotic use within the last three months prior to screening will be registered.
- Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) two weeks prior to screening and throughout the study. Specifically excluded drugs are opioids, NSAIDs on a weekly basis, regular use of laxatives and anti-diarrhoeal drugs, any drugs indicated for IBS symptoms.
- Diagnosed with and treated for IBS for more than 10 years
- Pregnant or lactating or wish to become pregnant during the period of the study.
- Lack of suitability for participation in the study for any reason as judged by the investigator.
Sites / Locations
- SU Sahlgrenska, Department of Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
HMO1
HMO2
Dextropur
Arm Description
Daily bolus of HMO1
Daily bolus of HMO2
Daily bolus of dextropur
Outcomes
Primary Outcome Measures
Change from baseline in intestinal bifidobacteria abundance
Secondary Outcome Measures
Change from baseline of faecal microbiota profile
Change from baseline of IBS symptoms as measured via the total score on the IBS Symptoms Severity Scale (IBS-SSS) and the proportion of responders in all patients and subgroup of patients
Change from baseline of intensity of abdominal pain and number of days of abdominal pain as measured on the 11 point Numeric Rating Scale (NRS-11) in all patients and subgroups of patients
Change from baseline of bowel habits as measured via the IBS-SSS, the Bristol Stool Form Scale (BSFS) and a bowel movement diary in all patients and subgroup of patients
Change from baseline of abdominal distention as measured via the IBS-SSS in all patients and subgroups of patients
Change from baseline of gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale for IBS patients (GSRS-IBS) in all patients and subgroup of patients
Change from baseline of quality of life in IBS patients as measured by the IBS-QOL in all patients and subgroups of patients
Change from baseline of anxiety and depression as measured by the Hospital Anxiety and Depression Scales (HADS) in all patients and subgroups of patients
Change from baseline of gastrointestinal symptom specific anxiety as measured by the Visceral Sensitivity Index (VSI) in all patients and subgroup of patients
Change from baseline of severity of somatic symptoms as measured by the Patient Health Questionnaire-15 (PHQ-15) in all patients and subgroup of patients
Change from baseline of biomarkers of inflammation in all patients and subgroups of patients
Change from baseline of biomarkers of gut barrier function in all patients and subgroups of patients
Change from baseline of biomarkers of the gut-brain axis in all patients and subgroups of patients
Full Information
NCT ID
NCT02875847
First Posted
August 12, 2016
Last Updated
September 21, 2018
Sponsor
Glycom A/S
Collaborators
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02875847
Brief Title
Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients
Official Title
The Effects of Human Milk Oligosaccharides on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in Irritable Bowel Syndrome: a Parellell, Double-blind, Randomised, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glycom A/S
Collaborators
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria will be included. The participants will be randomized into one of three groups consuming either HMO (two groups) or placebo (one group).
The primary objective of the study is to establish the effect of HMOs on the faecal microbiota in IBS patients. Secondary objectives are to assess the effect on gastrointestinal symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HMO1
Arm Type
Active Comparator
Arm Description
Daily bolus of HMO1
Arm Title
HMO2
Arm Type
Active Comparator
Arm Description
Daily bolus of HMO2
Arm Title
Dextropur
Arm Type
Placebo Comparator
Arm Description
Daily bolus of dextropur
Intervention Type
Dietary Supplement
Intervention Name(s)
HMO1
Intervention Type
Dietary Supplement
Intervention Name(s)
HMO2
Intervention Type
Dietary Supplement
Intervention Name(s)
Dextropur
Primary Outcome Measure Information:
Title
Change from baseline in intestinal bifidobacteria abundance
Time Frame
Baseline and after 4 weeks of intake
Secondary Outcome Measure Information:
Title
Change from baseline of faecal microbiota profile
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of IBS symptoms as measured via the total score on the IBS Symptoms Severity Scale (IBS-SSS) and the proportion of responders in all patients and subgroup of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of intensity of abdominal pain and number of days of abdominal pain as measured on the 11 point Numeric Rating Scale (NRS-11) in all patients and subgroups of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of bowel habits as measured via the IBS-SSS, the Bristol Stool Form Scale (BSFS) and a bowel movement diary in all patients and subgroup of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of abdominal distention as measured via the IBS-SSS in all patients and subgroups of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale for IBS patients (GSRS-IBS) in all patients and subgroup of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of quality of life in IBS patients as measured by the IBS-QOL in all patients and subgroups of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of anxiety and depression as measured by the Hospital Anxiety and Depression Scales (HADS) in all patients and subgroups of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of gastrointestinal symptom specific anxiety as measured by the Visceral Sensitivity Index (VSI) in all patients and subgroup of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of severity of somatic symptoms as measured by the Patient Health Questionnaire-15 (PHQ-15) in all patients and subgroup of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of biomarkers of inflammation in all patients and subgroups of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of biomarkers of gut barrier function in all patients and subgroups of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
Title
Change from baseline of biomarkers of the gut-brain axis in all patients and subgroups of patients
Time Frame
Baseline and after 4 weeks of intake, and after 4 weeks of wash-out
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent
Age between 18 and 75 years at visit 2
Fulfills definition of IBS-D, IBS-C or IBS-A/M according to Rome IV criteria
Have a global IBS-SSS score of >174 during the 2 weeks run-in period
Read, speak and understand Swedish
Ability and willingness to understand and comply with the study procedures
Exclusion Criteria:
Participation in a clinical intervention trial one month prior to screening visit and throughout the study.
Any known gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator; in particular
lactose intolerance
coeliac disease
Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
Severe psychiatric disease and/or psychological disturbance, as judged by the investigator.
Use of highly dosed probiotic supplements (yoghurt allowed) one month prior to the study and throughout the study. Excluded products are (i) probiotic supplements in the form of capsules, tablets, and powders in sachets, and (ii) probiotic food and drink products which contain high doses of probiotics. The excluded food and drink products are available in the form of yoghurts, drinking yoghurts, shots and drinks under brands such as Proviva, Actimel, Activia, Wellness, and Verum.
Consumption of antibiotic drugs one month prior to screening and throughout the study. Antibiotic use within the last three months prior to screening will be registered.
Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) two weeks prior to screening and throughout the study. Specifically excluded drugs are opioids, NSAIDs on a weekly basis, regular use of laxatives and anti-diarrhoeal drugs, any drugs indicated for IBS symptoms.
Diagnosed with and treated for IBS for more than 10 years
Pregnant or lactating or wish to become pregnant during the period of the study.
Lack of suitability for participation in the study for any reason as judged by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Simrén, MD, PhD
Organizational Affiliation
Department of Internal Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans Törnblom, MD, PhD
Organizational Affiliation
Department of Internal Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lena Öhman, PhD
Organizational Affiliation
Department of Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
SU Sahlgrenska, Department of Internal Medicine
City
Göteborg
ZIP/Postal Code
SE-413 35
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32536023
Citation
Iribarren C, Tornblom H, Aziz I, Magnusson MK, Sundin J, Vigsnaes LK, Amundsen ID, McConnell B, Seitzberg D, Ohman L, Simren M. Human milk oligosaccharide supplementation in irritable bowel syndrome patients: A parallel, randomized, double-blind, placebo-controlled study. Neurogastroenterol Motil. 2020 Oct;32(10):e13920. doi: 10.1111/nmo.13920. Epub 2020 Jun 14.
Results Reference
derived
Learn more about this trial
Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients
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