An interventional study of Riboflavin supplementation in Crohn Disease, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Other
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.
Rationale Recent studies show that in patients with Inflammatory Bowel Disease (IBD) a dysbiosis exists in the composition of the intestinal microbiota. In particular, the potentially pathogenic bacterium Escherichia coli (E. coli) is often more abundant in the bowel of IBD patients, and the anaerobic commensal Faecalibacterium prausnitzii (F. prausnitzii) is often reduced. This last mentioned bacteria is known to be abundant in the intestine of healthy individuals. It is known to produce butyrate, which stimulates the intestinal epithelium, and to secrete anti-inflammatory substances.
Riboflavin - also known as vitamin B2 - is required for a wide variety of cellular processes and has an important role in maintaining health in humans. In a pilot intervention with healthy volunteers it is shown that a riboflavin supplement increases the number of F. prausnitzii and results in a higher production of butyrate. In Crohn's disease patients, it is known that the amount of F. prausnitzii in the intestine is generally low. Furthermore, it is known that there is an association between the number of F. prausnitzii bacteria and the length of disease in remission.
This study will evaluate if supplementation of the diet with riboflavin in Crohn's disease patients will result in a similar increase in the amount of F. prausnitzii as in healthy volunteers. In this patient group, an increase in the number of F. prausnitzii bacteria in the bowel may result in a more favourable disease course. This will be assessed with faeces calprotectin and two questionnaires. Additionally the investigators will assess if there is any modulation by riboflavin on the other intestinal bacteria, short chain fatty acids (SCFAs) (such as butyrate), and the pH of the faeces. Finally, the effect of the riboflavin on the permeability of the gut will be evaluated with a Chroom-EDTA test, and a number of different biomarkers of permeability.
Hypothesis The hypothesis is that in Crohn's disease patients, supplementation of the diet with riboflavin results in an increase in the amount of F. prausnitzii, changes in microbial composition, increased fatty acid production, an increase in pH and a reduction of intestinal permeability. These changes might result in a more favourable disease course with less exacerbations.
Study design Prospective clinical study.
Study population and sample size In total 84 Crohn's disease patients will be included in this study, divided into two groups. Group 1 (n=42) will consist of patients with disease in remission (quiescent disease); group 2 (n=42) will consist of patients with active disease. In this study an adaptive design will be used. First 12 patients in the disease in remission group will be analysed. The methods of analysis and safety aspects will be taken into account.
Intervention Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 70 is close to the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
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Exclusion Criteria:
Group 1 (n=42) will consist of patients with disease in remission (quiescent disease).
Dietary Supplement: Riboflavin supplementation
Group 2 (n=42) will consist of patients with active disease.
Dietary Supplement: Riboflavin supplementation
Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks
Also known as: vitamin B2 supplementation
F. Prausnitzii (FISH Analysis).
The faeces is collected at different time points before and after riboflavin supplementation. To investigate the effect of a riboflavin supplement on the number of F. prausnitzii bacteria in the faeces of active and quiescent Crohn's disease patients.
Time frame: Different time points up to 6 weeks from start study: Day0, Day7, Day28
| Milestone | Riboflavin Supplementation in Quiescent Disease | Riboflavin Supplementation in Active Disease |
|---|---|---|
| Started | 40 | 30 |
| Completed | 40 | 30 |
| Not completed | 0 | 0 |
The faeces is collected at different time points before and after riboflavin supplementation. To investigate the effect of a riboflavin supplement on the number of F. prausnitzii bacteria in the faeces of active and quiescent Crohn's disease patients.
| Relative FISH counts from total bacteria | Riboflavin Supplementation in Quiescent Disease | Riboflavin Supplementation in Active Disease |
|---|---|---|
| T0 (Mean of Day 0 and Day 7 combined) | 4.53 (0.00 to 12.77) | 5.07 (0.00 to 14.03) |
| T3 (Day 28) | 6.19 (0.00 to 13.10) | 5.46 (0.00 to 11.98) |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Riboflavin Supplementation in Quiescent Disease | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Riboflavin Supplementation in Active Disease | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Riboflavin Supplementation in Quiescent Disease | Riboflavin Supplementation in Active Disease | Total |
|---|---|---|---|
| Mean | 44.2 ± 11.6 | 38.8 ± 13.6 | 41.9 ± 12.7 |
| Sex: Female, Male(Participants) | Riboflavin Supplementation in Quiescent Disease | Riboflavin Supplementation in Active Disease | Total |
|---|---|---|---|
| Female | 29 | 19 | 48 |
| Male | 11 | 11 | 22 |
| Race (NIH/OMB)(Participants) | Riboflavin Supplementation in Quiescent Disease | Riboflavin Supplementation in Active Disease | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 40 | 30 | 70 |
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University Medical Center Groningen