Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Butyricicoccus pullicaecorum 25-3T; Other: Maltodextrin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KULeuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Butyricicoccus pullicaecorum; Lyophilized Butyricicoccus pullicaecorum 25-3T bacteria, encapsulated with a pH-resistent coating.	Dietary supplement: Butyricicoccus pullicaecorum 25-3T; Other Names: LMG 24109T; CCUG 55265T
Placebo Comparator: Placebo (maltodextrin); Lyophilized maltodextrin, encapsulated with a pH-resistent coating.	Other: Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 17, 2015
• First Posted (Estimate): June 22, 2015

Study Record Updates

• Last Update Posted (Estimate): June 22, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: ML9449