NCT02538354

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 3, 2020

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

August 20, 2015

Results QC Date

March 1, 2020

Last Update Submit

March 22, 2020

Conditions

Crohn Disease

Keywords

Riboflavin (vitamin B2)Faecalibacterium prausnitzii

Outcome Measures

Primary Outcomes (1)

  • 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.

    Different time points up to 6 weeks from start study: Day0, Day7, Day28

Study Arms (2)

Riboflavin supplementation in quiescent disease

EXPERIMENTAL

Group 1 (n=42) will consist of patients with disease in remission (quiescent disease).

Dietary Supplement: Riboflavin supplementation

Riboflavin supplementation in active disease

EXPERIMENTAL

Group 2 (n=42) will consist of patients with active disease.

Dietary Supplement: Riboflavin supplementation

Interventions

Riboflavin supplementationDIETARY_SUPPLEMENT

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

Also known as: vitamin B2 supplementation
Riboflavin supplementation in active diseaseRiboflavin supplementation in quiescent disease

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Crohn's disease patients
  • Age 18-65 years
  • Concomitant medication for Crohn's disease is allowed in all groups

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (9)

  • Sartor RB. Microbial influences in inflammatory bowel diseases. Gastroenterology. 2008 Feb;134(2):577-94. doi: 10.1053/j.gastro.2007.11.059.

    PMID: 18242222BACKGROUND

  • Sokol H, Pigneur B, Watterlot L, Lakhdari O, Bermudez-Humaran LG, Gratadoux JJ, Blugeon S, Bridonneau C, Furet JP, Corthier G, Grangette C, Vasquez N, Pochart P, Trugnan G, Thomas G, Blottiere HM, Dore J, Marteau P, Seksik P, Langella P. Faecalibacterium prausnitzii is an anti-inflammatory commensal bacterium identified by gut microbiota analysis of Crohn disease patients. Proc Natl Acad Sci U S A. 2008 Oct 28;105(43):16731-6. doi: 10.1073/pnas.0804812105. Epub 2008 Oct 20.

    PMID: 18936492BACKGROUND

  • Fujimoto T, Imaeda H, Takahashi K, Kasumi E, Bamba S, Fujiyama Y, Andoh A. Decreased abundance of Faecalibacterium prausnitzii in the gut microbiota of Crohn's disease. J Gastroenterol Hepatol. 2013 Apr;28(4):613-9. doi: 10.1111/jgh.12073.

    PMID: 23216550BACKGROUND

  • Willing B, Halfvarson J, Dicksved J, Rosenquist M, Jarnerot G, Engstrand L, Tysk C, Jansson JK. Twin studies reveal specific imbalances in the mucosa-associated microbiota of patients with ileal Crohn's disease. Inflamm Bowel Dis. 2009 May;15(5):653-60. doi: 10.1002/ibd.20783.

    PMID: 19023901BACKGROUND

  • Sokol H, Seksik P, Furet JP, Firmesse O, Nion-Larmurier I, Beaugerie L, Cosnes J, Corthier G, Marteau P, Dore J. Low counts of Faecalibacterium prausnitzii in colitis microbiota. Inflamm Bowel Dis. 2009 Aug;15(8):1183-9. doi: 10.1002/ibd.20903.

    PMID: 19235886BACKGROUND

  • Miquel S, Martin R, Rossi O, Bermudez-Humaran LG, Chatel JM, Sokol H, Thomas M, Wells JM, Langella P. Faecalibacterium prausnitzii and human intestinal health. Curr Opin Microbiol. 2013 Jun;16(3):255-61. doi: 10.1016/j.mib.2013.06.003. Epub 2013 Jul 3.

    PMID: 23831042BACKGROUND

  • Louis P, Flint HJ. Diversity, metabolism and microbial ecology of butyrate-producing bacteria from the human large intestine. FEMS Microbiol Lett. 2009 May;294(1):1-8. doi: 10.1111/j.1574-6968.2009.01514.x. Epub 2009 Feb 13.

    PMID: 19222573BACKGROUND

  • Khan MT, Duncan SH, Stams AJ, van Dijl JM, Flint HJ, Harmsen HJ. The gut anaerobe Faecalibacterium prausnitzii uses an extracellular electron shuttle to grow at oxic-anoxic interphases. ISME J. 2012 Aug;6(8):1578-85. doi: 10.1038/ismej.2012.5. Epub 2012 Feb 23.

    PMID: 22357539BACKGROUND

  • Swidsinski A, Loening-Baucke V, Vaneechoutte M, Doerffel Y. Active Crohn's disease and ulcerative colitis can be specifically diagnosed and monitored based on the biostructure of the fecal flora. Inflamm Bowel Dis. 2008 Feb;14(2):147-61. doi: 10.1002/ibd.20330.

    PMID: 18050295BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
dr. J.Z.H. von Martels
Organization
Universy Medical Center Groningen
j.z.h.von.martels@umcg.nl
0031503616161

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. G. Dijkstra

Study Record Dates

First Submitted

August 20, 2015

First Posted

September 2, 2015

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 3, 2020

Results First Posted

April 3, 2020

Record last verified: 2020-03

Locations

NL(1)