Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2025-06-30

Brief Summary

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The goal of this intervention study is to evaluate the beneficial effect of the probiotic bacterium Bacillus coagulans in healthy volunteers. The main question it aims to answer is if the probiotic strains are modifying the microbiota composition in a beneficial way, evaluated in faecal- and saliva samples.

Primary hypothesis: The probiotic bacteria will modify the microbiota composition in faecal- and saliva samples.

Participants will consume the freeze-dried probiotic bacteria for 14 days. Before and after consumption, the participants will collect samples.

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Detailed Description

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Samples will be frozen immediately after collection and will be kept frozen until analysis at the Department of Process and Life Science Engineering, Faculty of Engineering, Lund University. For diversity measures, species identification and relative abundance of bacterial taxa, samples will be analysed by Illuminas MiSeq with the MiSeq reagent kit v3. Data will be analysed with bioinformatic pipeline QIIME2TM.

Conditions

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Microbiota Analysis in Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Consumption of probiotics strain 5

The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 5).

Group Type EXPERIMENTAL

Consumption of probiotics strain 5

Intervention Type DIETARY_SUPPLEMENT

Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 5.

Consumption of probiotics strain 6

The participants will consume a probiotic product, a capsule with freeze-dries bacteria (B. coagulans strain 6).

Group Type EXPERIMENTAL

Consumption of probiotics strain 6

Intervention Type DIETARY_SUPPLEMENT

Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 6.

Interventions

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Consumption of probiotics strain 5

Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 5.

Intervention Type DIETARY_SUPPLEMENT

Consumption of probiotics strain 6

Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 6.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

• You must be 18-65 years of age.

Exclusion Criteria

* Participants must not be diagnosed with gastrointestinal diseases, autoimmune diseases or have diseases or medications that cause immune deficiency such as MS, type 1 diabetes, cancer or HIV.
* Participants must not have taken antibiotics in the month before or during the study.
* Participants must not consume other probiotic products or fermented foods during the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes