Trial Outcomes & Findings for The Effect of Riboflavin in Crohn's Disease (NCT NCT02538354)
NCT ID: NCT02538354
Last Updated: 2020-04-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Different time points up to 6 weeks from start study: Day0, Day7, Day28
Results posted on
2020-04-03
Participant Flow
Participant milestones
| Measure |
Riboflavin Supplementation in Quiescent Disease
Group 1 (n=42) will consist of patients with disease in remission (quiescent disease).
Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks
|
Riboflavin Supplementation in Active Disease
Group 2 (n=42) will consist of patients with active disease.
Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
30
|
|
Overall Study
COMPLETED
|
40
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Riboflavin in Crohn's Disease
Baseline characteristics by cohort
| Measure |
Riboflavin Supplementation in Quiescent Disease
n=40 Participants
Group 1 (n=42) will consist of patients with disease in remission (quiescent disease).
Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks
|
Riboflavin Supplementation in Active Disease
n=30 Participants
Group 2 (n=42) will consist of patients with active disease.
Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Different time points up to 6 weeks from start study: Day0, Day7, Day28The 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.
Outcome measures
| Measure |
Riboflavin Supplementation in Quiescent Disease
n=40 Participants
Group 1 (n=42) will consist of patients with disease in remission (quiescent disease).
Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks
|
Riboflavin Supplementation in Active Disease
n=30 Participants
Group 2 (n=42) will consist of patients with active disease.
Riboflavin supplementation: Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks
|
|---|---|---|
|
F. Prausnitzii (FISH Analysis).
T0 (Mean of Day 0 and Day 7 combined)
|
4.53 Relative FISH counts from total bacteria
Interval 0.0 to 12.77
|
5.07 Relative FISH counts from total bacteria
Interval 0.0 to 14.03
|
|
F. Prausnitzii (FISH Analysis).
T3 (Day 28)
|
6.19 Relative FISH counts from total bacteria
Interval 0.0 to 13.1
|
5.46 Relative FISH counts from total bacteria
Interval 0.0 to 11.98
|
Adverse Events
Riboflavin Supplementation in Quiescent Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Riboflavin Supplementation in Active Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
dr. J.Z.H. von Martels
Universy Medical Center Groningen
Phone: 0031503616161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place