N/A
N=70
The Effect of Riboflavin in Crohn's Disease
Crohn Disease
Bottom Line
View on ClinicalTrials.gov: NCT02538354 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: F. Prausnitzii (FISH Analysis). — 4.53; 5.07; 6.19; 5.46 Relative FISH counts from total bacteria
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Riboflavin supplementation (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Medical Center Groningen
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY F. Prausnitzii (FISH Analysis). |
4.53; 5.07; 6.19; 5.46 | — |
Summary
This study will evaluate if suppelementation of the diet with riboflavin in Crohn's disease patients will result in an increase in the amount of F. prausnitzii.
Eligibility Criteria
Inclusion Criteria
- Crohn's disease patients
- Age 18-65 years
- Concomitant medication for Crohn's disease is allowed in all groups
Exclusion Criteria
- Swallowing disorders
- Pregnancy and lactation
- Use of antibiotic drugs, probiotics (i.e.Yakult, Vifit, Activia etc) or specific prebiotic supplements in the 3 weeks prior to the riboflavin intervention
- Use of Methotrexate drugs
- Colonoscopy and colon cleansing in last 3 months
- Use of a vitamin B2 supplement, or multivitamin complexes containing vitamin B (i.e. vitamin B-complex) in the 3 weeks prior to the riboflavin intervention
- Severe Crohn's disease (HBI > 12)
Data sourced from ClinicalTrials.gov (NCT02538354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.