Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477033
• Other study ID #: ML9449
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2015
• Last updated: June 17, 2015
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Butyricicoccus pullicaecorum 25-3T

Other:
• Maltodextrin

Locations

Country	Name	City	State
Belgium	KULeuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements		1 year	No
Secondary	The effect of Butyricicoccus pullicaecorum intake on gut microbiota composition, measured by 16S rDNA Illumina profiling of the bacterial communities		1 year	No
Secondary	The effect of Butyricicoccus pullicaecorum intake on gut microbiota activity, measured by GC-MS analysis of the fecal volatile organic compounds		1 year	No