Status:
COMPLETED
Nutrition to Relieve IBS Constipation
Lead Sponsor:
Wageningen University and Research
Collaborating Sponsors:
Ministery of Economic affairs
Nexira
Conditions:
Irritable Bowel Syndrome
Constipation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Rationale: Irritable Bowel Syndrome (IBS) is a disease that affects a large number of people. To date, no adequate treatment is available. This is partially due to the heterogeneity of the patients an...
Eligibility Criteria
Inclusion
- IBS patients that meet the Rome IV criteria + additional criteria specific for the constipation-predominant subtype, based on the most frequent self-reported stool types using the Bristol stool chart (BSC). These criteria will be assessed via the inclusion questionnaire and will be evaluated by the medical supervisor.
- Male and female adults, aged 18-70 years.
- Have a Body Mass Index (BMI) between 18.5 and 30 kg/m2 (self-reported).
- Willing to keep a stable dietary pattern throughout the study.
- Having a smartphone to fill out the daily questionnaires
Exclusion
- Having a disease that may interfere with the outcomes of this study, such as a known autonomic disorder, inflammatory bowel disease, coeliac disease, cancer, dialysis patients, chronic kidney failure, depression or hypothyroidism.
- History of intestinal surgery (excluding appendectomy or cholecystectomy) or endometriosis.
- Use of medication that can interfere with the study outcomes, including antidepressants (allowed when it is not subscribed for mental depression), codeine, and antibiotics, as judged by the medical supervisor MD Ben Witteman.
- Use of prescribed 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.
- Use of prebiotics and/or probiotics (should be stopped 4 weeks before the start of the study) and infrequent use of other (fiber) supplements dedicated to bowel function improvements. 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).
- If applicable: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool pattern and wellbeing.
- Participation in another clinical trial at the same time.
- Student or employee working at Food, Health and Consumer Research from Food and Biobased Research, or Department of Human Nutrition \& Health, Wageningen University.
- Alcohol intake ≥ 2 (women) or ≥ 4 (men) glasses of alcoholic beverages per day.
- Abuse of illicit drugs, soft drugs, and nitrous oxide.
- Smoking.
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04798417
Start Date
March 8 2021
End Date
July 15 2021
Last Update
July 30 2021
Active Locations (1)
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1
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands, 6708 WG