The present study will evaluate if supplementation of the diet with riboflavin in Crohn*s disease patients will result in a similar increase in the number of F. prausnitzii as seen in the healthy volunteers. Potentially an even larger effect can…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1). 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.
Secondary outcome
1). To evaluate the effect of a riboflavin supplement on the bacterial
composition in the faeces of active and quiescent Crohn*s disease patients.
2). To evaluate the effect of a riboflavin supplement on the production of
short chain fatty acids (SCFAs) in the faeces of active and quiescent Crohn*s
disease patients.
3). To assess the effect of the riboflavin intervention on the disease severity
(Harvey Bradshaw Index, IBD-Q and faeces Calprotectin) of active and quiescent
Crohn*s disease patients.
4). To evaluate the effect of the riboflavin intervention on permeability of
the gut in active and quiescent Crohn*s disease patients (Chroom-EDTA test, and
different biomarkers of permeability).
5). To determine the effect of a riboflavin supplement on the faecal pH in
active and quiescent Crohn*s disease patients.
6). To evaluate whether riboflavin intervention leads to an increase in
electrical current, as a result of an increase in extracellular electron
shuttling bacteria.
Background summary
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 we 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.
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 objective
The present study will evaluate if supplementation of the diet with riboflavin
in Crohn*s disease patients will result in a similar increase in the number of
F. prausnitzii as seen in the healthy volunteers. Potentially an even larger
effect can occur, because of the low starting amount. In this patient group, an
increase in the number of F. prausnitzii may result in a more favourable
disease course.
Study design
Prospective clinical study.
Intervention
Supplementation of the normal diet with 1 capsule (100 mg) of riboflavin
(vitamin B2) during three weeks.
Study burden and risks
Participating in this study has a potential health benefit. It is known that in
healthy subjects, the supplement riboflavin increases the amount of beneficial
bacteria. In Crohn*s disease there is often a dysbiosis of the bacterial
composition, and the beneficial bacteria are depleted. When a similar increase
in the beneficial bacteria occurs in Crohn*s disease patients as seen in
healthy volunteers, this may result in a more favourable disease outcome
(staying in remission longer). Riboflavin is freely available, and commonly
sold in health shops. There is no need for a prescription to buy this
supplement, and its use is considered to be safe. The riboflavin supplement may
give a (completely innocent) yellow discoloration of the urine several hours
after ingestion. There is no need to discontinue the riboflavin
supplementation. The adverse event of discoloration of urine is only temporary.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Group 1 (n=42)
- Patients diagnosed with Crohn*s Disease in remission (Calprotectin < 200 µg/g)
- Age 18-65 years;Group 2 (n=42)
- Patients diagnosed with Crohn*s Disease with active disease (Calprotectin > 200 µg/g)
- Age 18-65 years
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 (for a list of probiotic, prebiotic and other supplements see attachment 2)
- 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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Het onderzoek wordt na goedkeuring geregistreerd op clinicaltrials.gov. |
| CCMO | NL48186.042.14 |