Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT02477033
• Lead Sponsor: KU Leuven

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-06
• Study Completion: 2015-02
• Status Verified: 2015-06
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-17
• Last Update Submitted: 2015-06-17
• Study First Posted: 2015-06-22
• Last Update Posted: 2015-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

KULeuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium