Impact of Butyricicoccus Pullicaecorum in Healthy Subjects

Study Overview
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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.

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

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Butyricicoccus pullicaecorum 25-3T
* Other: Maltodextrin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Butyricicoccus pullicaecorum<br>Lyophilized Butyricicoccus pullicaecorum 25-3T bacteria, encapsulated with a pH-resistent coating. | Dietary Supplement: Butyricicoccus pullicaecorum 25-3T<br> <br> * Other names: LMG 24109T; CCUG 55265T;|
| Placebo Comparator: Placebo (maltodextrin)<br>Lyophilized maltodextrin, encapsulated with a pH-resistent coating. | Other: Maltodextrin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |