utrition to relieve IBS constipatio
- Conditions
- Irritable Bowel Syndrome10016950
- Registration Number
- NL-OMON50958
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
* IBS patients that meet the Rome IV criteria + additional criteria specific
for the constipation-predominant subtype.
* 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
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is stool pattern: stool frequency, stool<br /><br>consistency and stool volume.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters are gastrointestinal complaints, Quality of<br /><br>Life, and HADS.</p><br>