Status:
COMPLETED
Nutrition to Relieve IBS Symptoms by Targeting the Microbiota
Lead Sponsor:
Wageningen University and Research
Collaborating Sponsors:
Ministery of Economic affairs
Nexira
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Rationale: Irritable Bowel Syndrome (IBS) is functional gastrointestinal disorder that affects a large number of people. To date, no adequate treatment is available. This is partially due to the heter...
Eligibility Criteria
Inclusion
- IBS patients that meet the Rome IV criteria. This will be evaluated by the medical supervisor;
- Male and female adults, aged 18-65 years;
- Having a Body Mass Index (BMI) between 18.5 and 30 kg/m2;
- Willing to keep a stable dietary pattern throughout the study;
- Having a smartphone to fill out the daily questionnaires.
Exclusion
- Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, or Ulcerative colitis;
- Having a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy;
- Having a food allergy to milk protein or pulse protein;
- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease;
- When applicable: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool patterns and wellbeing;
- Use of antibiotic treatment less than 3 months before start of the study and no use of antibiotics during the study;
- Use of prebiotics and/or probiotics (should be stopped 4 weeks before the start of the study) and infrequent use of other (fiber) supplements. Some supplements are allowed, but intake should be kept stable during the whole study period (Supplements will be judged by the medical supervisor MD Ben Witteman);
- Currently following a FODMAP-restricted diet;
- Use of medication that can interfere with the study outcomes, including anxiolytics, proton pump inhibitors, laxatives (Over-the-counter laxatives are allowed, but intake should be either stopped before the start of the study or kept stable during the complete study period), and codeine, as judged by the medical supervisor MD Ben Witteman;
- Participation in another clinical trial at the same time;
- Student or employee working at Food, Health and Consumer Research from Wageningen Food and Biobased Research;
- Alcohol intake ≥ 2 (women) or ≥ 4 (men) glasses of alcoholic beverages per day;
- Abuse of illicit drugs;
- Being incapacitated.
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04790422
Start Date
May 11 2021
End Date
July 16 2021
Last Update
July 30 2021
Active Locations (1)
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1
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands, 6708 WG