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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02477033

Enrollment

Registered

2015-06-22

Start date

2014-02-28

Completion date

2015-02-28

Last updated

2015-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DIETARY_SUPPLEMENTButyricicoccus pullicaecorum 25-3T

OTHERMaltodextrin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026