NCT05579483Withdrawn
Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 4 Oct 2022
- Start date
- Dec 2023
- Primary completion date
- Oct 2024
- Lead sponsor
- Wageningen University
- Diseases
- Ulcerative colitis
- NCT number
- NCT05579483
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other underlying disease of the GI-tract or previous bowel surgery, except cholecystectomy and appendectomy
- Use of medication that can interfere with the study outcomes, as judged by the medical supervisor
- Systemic antibiotics and proton pump inhibitors (except for omeprazole and pantoprazole with dosage <20 mg), prebiotic supplements, probiotic supplements four weeks prior to study start
Other
- Pregnancy or intending to become pregnant during the study
- The need for antibiotic use during the intervention period
- Currently participating in another intervention study
- Acquaintances of anyone in the research team
Who the study is looking for
- Male and female subjects aged 18 to 65 years
- Body Mass Index (BMI) between 18 and 30 kg/m2 (self-reported)
- Ulcerative Colitis confirmed via previous endoscopy and histology
- Mild active UC as defined by P-SCCAI score of 3 to 5 (range 0 to 19)
- Frequent relapse (at least one exacerbation in the last two years)
- No known allergy to any components of the study product (self-reported)
- Signed informed consent
- Stable UC medication defined as no switch to other medication or no dose change
- 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)
- Stable dietary pattern during the study
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wageningen University Coordinator of this site? Confirm its status | Wageningen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.