utrition to Relieve IBS symptoms by targeting the Microbiota
- Conditions
- Irritable Bowel Syndrome (IBS)10016950
- Registration Number
- NL-OMON51091
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
- 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;
- 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 (antidepressants are allowed), laxatives (Over-the-counter
laxatives are allowed, but intake should be either stopped at least 4 weeks
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the (relative) abundance of fecal Bifidobacterium.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters are fecal microbiota composition, fecal SCFAs,<br /><br>stool frequency and consistency, IBS-related complaints, and Quality of Life.</p><br>