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Completed

NCT Number: NCT02477033

Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Butyricicoccus pullicaecorum 25-3T

Dietary Supplement

Other names: LMG 24109T; CCUG 55265T

maltodextrin

Other

Primary outcomes

  1. 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

  1. The effect of Butyricicoccus pullicaecorum intake on gut microbiota composition, measured by 16S rDNA Illumina profiling of the bacterial communities

    Time frame: 1 year

  2. The effect of Butyricicoccus pullicaecorum intake on gut microbiota activity, measured by GC-MS analysis of the fecal volatile organic compounds

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 22, 2015
Registry last updated
Jun 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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