Prediction of dietary intervention efficacy in mild ulcerative colitis patients based on fecal microbiome signatures - PREDUCTOME study

Wageningen Universiteit0 sites60 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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 Patient Simple Clinical Colitis Activity Index
•(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
•9\. mobile phone on which apps (used for questionnaires) can be downloaded

•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 study period
•5\. 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.
•6\. Currently participating in another intervention study