The effect of riboflavin supplementation on Faecalibacterium prausnitzii in Crohn's disease

The effect of riboflavin supplementation on Faecalibacterium prausnitzii in Crohn's disease - Riboflavin in Crohn's disease / RISE-UP study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41902

Enrollment

Registered

2015-04-20

Start date

2016-01-11

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease M. Crohn

Interventions

Supplementation of the normal diet with 1 capsule (100 mg) of riboflavin (vitamin B2) during three weeks.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group 1 (n=42) - Patients diagnosed with Crohn*s Disease in remission (Calprotectin 200 µg/g) - Age 18-65 years

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1). To evaluate the effect of a riboflavin supplement on the bacterial composition in the faeces of active and quiescent Crohns 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 Crohns 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 Crohns disease patients. 4). To evaluate the effect of the riboflavin intervention on permeability of the gut in active and quiescent Crohns 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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)