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Withdrawn
NCT05579483
Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures
Conditions: Ulcerative Colitis
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Sponsor: Wageningen University
Location: Wageningen University Wageningen Gelderland
Summary
A double-blind randomized placebo-controlled parallel trial with two intervention arms and two placebo arms and a period of eight intervention weeks to validate the prediction that prebiotics could induce a higher response in mild UC patients with certain fecal microbiome signatures.
Eligibility Criteria
Inclusion Criteria:
1. Male and female subjects aged 18 to 65 years
2. Body Mass Index (BMI) between 18 and 30 kg/m2 (self-reported)
3. Ulcerative Colitis confirmed via previous endoscopy and histology
4. Mild active UC as defined by P-SCCAI score of 3 to 5 (range 0 to 19)
5. Frequent relapse (at least one exacerbation in the last two years)
6. No known allergy to any components of the study product (self-reported)
7. Signed informed consent
8. Stable UC medication defined as no switch to other medication or no dose change
9. Mobile phone on which apps (used for questionnaires) can be downloaded (iOS version 9 and newer, Android version 4.4 and newer. Phones manufactured after 2013 are usually suitable)
10. Stable dietary pattern during the study
Exclusion Criteria:
1. Any other underlying disease of the GI-tract or previous bowel surgery, except cholecystectomy and appendectomy
2. Pregnancy or intending to become pregnant during the study
3. Use of medication that can interfere with the study outcomes, as judged by the medical supervisor
4. The need for antibiotic use during the intervention period
5. Systemic antibiotics and proton pump inhibitors (except for omeprazole and pantoprazole with dosage \
Source: ClinicalTrials.gov (NCT05579483). StuddyBuddy aggregates publicly available trial information.