Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

NCT02477033 | Completed Phase 1

• 1 other identifier: ML9449
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (2)

• 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

Study Arms (2)

Butyricicoccus pullicaecorum

ACTIVE COMPARATOR

Lyophilized Butyricicoccus pullicaecorum 25-3T bacteria, encapsulated with a pH-resistent coating.

Dietary Supplement: Butyricicoccus pullicaecorum 25-3T

Placebo (maltodextrin)

PLACEBO COMPARATOR

Lyophilized maltodextrin, encapsulated with a pH-resistent coating.

Other: Maltodextrin

Interventions

Butyricicoccus pullicaecorum 25-3T DIETARY_SUPPLEMENT

Also known as: LMG 24109T; CCUG 55265T

Butyricicoccus pullicaecorum

Maltodextrin OTHER

Placebo (maltodextrin)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

maltodextrin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Kristin Verbeke

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 22, 2015
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2015
• Last Updated: June 22, 2015

Record last verified: 2015-06

Locations

BE (1)