A Placebo-controlled Cross-over Randomized Study to Investigate the Impact of Butyricicoccus Pullicaecorum in Healthy Human Volunteers

KU Leuven1 site in 1 country30 target enrollmentFebruary 2014

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: KU Leuven
Enrollment: 30
Locations: 1
Primary Endpoint: Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

During this project the safety, tolerability and effect on gut microbiota of oral administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers by a placebo-controlled cross-over randomized study.

Detailed Description

Intervention periods were 4 weeks, with daily intake of 1 capsule. Wash-out periods were 3 weeks.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

February 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

KU Leuven

Responsible Party

Principal Investigator

Kristin Verbeke

Professor Kristin Verbeke

KU Leuven

Eligibility Criteria

Inclusion Criteria

•BMI between 18 and 28 kg/m²
•Good general health
•Regular eating pattern (3 meals/day on at least 5 days/week)

Exclusion Criteria

•Chronic gastrointestinal disease (Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation or chronic diarrhea)
•Surgery of the gastrointestinal tract (except for an appendectomy)
•Use of antibiotics during the month preceding the study
•Use of medication or dietary supplements influencing gut transit or intestinal microbiota during the month preceding the study. Examples of such medication/dietary supplements are antispasmodics (e.g. buscopan), antidiarrheal medication (e.g. imodium), probiotic medication (e.g. lacteol, enterol)
•Intake of pre- or probiotics during the study or during the month preceding the study
•Being on a weight-loss diet during the study or during the month preceding the study
•Extreme dietary habits (e.g. vegan, Atkins diet, Montignac diet)
•Females who are pregnant, lactating or planning to become pregnant during the study period

Outcomes

Primary Outcomes

Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements

Time Frame: 1 year

Secondary Outcomes

The effect of Butyricicoccus pullicaecorum intake on gut microbiota composition, measured by 16S rDNA Illumina profiling of the bacterial communities(1 year)
The effect of Butyricicoccus pullicaecorum intake on gut microbiota activity, measured by GC-MS analysis of the fecal volatile organic compounds(1 year)