Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

Catholic University (KU) of Leuven

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Other: Maltodextrin

Dietary Supplement: Butyricicoccus pullicaecorum 25-3T

Study type

Interventional

Funder types

Other

Identifiers

NCT02477033

ML9449

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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