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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46540
Enrollment
130
Registered
2018-05-03
Start date
2018-09-06
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic colon

Interventions

None listed

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Primary endpoint of this study is microbiota composition and metabolite profiles, and the difference between groups and possible change after one month. These are assessed two faecal samples, which are analysed by 16S rRNA gene-based microbiota profiling.

Secondary

MeasureTime frame
Secondary parameters are dietary intake, Quality of Life, depression and anxiety scores, and stool consistency and frequency, which are assessed by validated questionnaires.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)