Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria

Lund University

Status: Enrolling

Conditions: Microbiota Analysis in Healthy Subjects

Treatments: Dietary Supplement: Consumption of probiotics strain 6; Dietary Supplement: Consumption of probiotics strain 5

Study type: Interventional

Funder types: Other

Identifiers

NCT07046897

Lund University, LTH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Consumption of probiotics strain 5

Experimental group

Description:

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

Treatment:

Dietary Supplement: Consumption of probiotics strain 5

Consumption of probiotics strain 6

Experimental group

Description:

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

Treatment:

Dietary Supplement: Consumption of probiotics strain 6