Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-02-28

Brief Summary

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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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Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Butyricicoccus pullicaecorum

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

Group Type ACTIVE_COMPARATOR

Butyricicoccus pullicaecorum 25-3T

Intervention Type DIETARY_SUPPLEMENT

Placebo (maltodextrin)

Lyophilized maltodextrin, encapsulated with a pH-resistent coating.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type OTHER

Interventions

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Butyricicoccus pullicaecorum 25-3T

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type OTHER

Other Intervention Names

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LMG 24109T; CCUG 55265T

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes