IBSQUtrition: Microbiota and Metabolite Profiles Linked to Severity in Irritable Bowel Syndrome

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

For IBS patients:
- Adults, aged 18-65 years.
- IBS patients that meet the Rome IV criteria.
- In close proximity of Wageningen (max. 50 km), for practical reasons: collection of the faecal samples.
- Have an Body Mass Index (BMI) between 18.5 and 30 kg/m2.
- Signed informed consent.
- After T1, IBS severity will be checked using the IBS-SSS. Subjects will be included for follow-up at T2, when they have the most mild symptoms (n<=30) or most severe (n<=30) symptoms. ;Healthy controls: will be age (±5 years), gender and BMI (±1kg/m2) matched with IBS patients. Other criteria:
- Adults, aged 18-65 years.
- No history of IBS, as assessed by the Rome IV criteria.
- Has a score <75 from the IBS-SSS.
- Are age (±5 years), gender and Body Mass Index (±1 kg/m2) matched with IBS patients.
- In close proximity of Wageningen (max. 50 km), for practical reasons: collection of the faecal samples.
- Signed informed consent.

Exclusion Criteria

For IBS patients:
Presence of gastro-intestinal diseases, such as celiac disease, Crohn*s disease, or Ulcerative colitis.
- Have a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy.
- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease.
- Female participants: currently pregnant or breast-feeding.
- Use of antibiotic treatment less than 3 months before start of the study and no use of antibiotics during the study.
- Are not participanting in another study during this study.
- Are an employee or student of the Division of Human Nutrition, Food and Biobased Research or Laboratory of Microbiologie, of Wageningen University & Research.
- Unwilling or unable to fulfil study criteria.
- If they are not selected in the most mild or most severe group at T1. ;For healthy controls:
- Presence of gastro-intestinal diseases, such as celiac disease, Crohn*s disease, or Ulcerative colitis.
- Have a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy.
- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease.
- Female subjects: currently pregnant or breast-feeding.
- Use of antibiotic treatment less than 3 months before start of the study.
- Are an employee of the Division of Human Nutrition, Food and Biobased Research or Laboratory of Microbiology, of Wageningen University & Research.
- Are subjects in another study during this study.
- Unwilling or unable to fulfil study criteria.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint of this study is microbiota composition and metabolite<br /><br>profiles, and the difference between groups and possible change after one<br /><br>month. These are assessed two faecal samples, which are analysed by 16S rRNA<br /><br>gene-based microbiota profiling. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are dietary intake, Quality of Life, depression and<br /><br>anxiety scores, and stool consistency and frequency, which are assessed by<br /><br>validated questionnaires. </p><br>