This study assesses the effects of a probiotic or postbiotic on gut microbiome during antibiotic treatment.
Males and females aged ≥18 to ≤ 65 years; if female, either not of childbearing potential or using a medically approved method of birth control and willing to take a pregnancy test at screening.
Body mass index (BMI) 18.5-29.9 kg/m².
Healthy as determined by medical history and physical examination.
Agreed not to change current dietary habits during the course of the study.
Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the study.
People on vegetarian or vegan diet; People on special diet (e.g. Ducan, Keto, etc.)
BMI ≥ 30 kg/m² or <18.5 kg/m².
History of intake of antibiotics, other probiotics, postbiotics, prebiotics, synbiotics, proton pump inhibitors, acid sequestrants (cholestyramine, Bile colestipol), within six months prior to the screening day.
Parallel
Probiotic
Dietary supplementParticipants in this arm will receive a daily dose of of a probiotic (live bacterium), in a form of 2 capsules once daily, for 28 days.
Postbiotic
Dietary supplementParticipants in this arm will receive a daily dose of a postbiotic (heat-inactivated bacterium), in a form of 2 capsules once daily, for 28 days.
Placebo
Dietary supplementParticipants in this arm will receive an equivalent placebo for the duration of the study (28 days).
Changes in gut microbiome composition between baseline and day 14 as compared to placebo.
To assess the effects of a probiotic or postbiotic in gut microbiome composition of healthy adults receiving antibiotic therapy, as measured by changes in alpha and beta diversity of the gut microbiome as compared to placebo.
Changes in gut microbiome composition throughout the study as compared to placebo and baseline.
Changes in microbiome composition as measured by changes in alpha and beta diversity of the gut microbiome throughout the study as compared to placebo and baseline.
Changes in abundance of beneficial versus opportunistic/ pathogenic bacterial species throughout the study as compared to baseline and to placebo
Effects of a probiotic or postbiotic on the abundance of beneficial versus opportunistic/pathogenic bacterial species throughout the study as compared to baseline and to placebo.
Changes in the abundances of microbial genes contained in specific functional modules through the study as compared to baseline and placebo.
Effects of probiotic or postbiotic on the abundances of genes contained in specific functional modules obtained from KEGG database. A Gene Set Enrichment Analysis (GSEA) is performed to obtain which modules are enriched by the biotics effect thought the study. Significant associations will be reported with the Normalized Enrichment score (NES) and adj.p.value.
Study the associations of specific microbe abundances with the development of gastrointestinal (GI) symptoms
Association between each bacterial abundance and the clinical measures, related to GI symptoms, will be performed using linear models. Significant associations will be reported with the linear model coefficient and adj.p.value.
Effects on development of antibiotic-associated diarrhea (AAD) as compared to placebo.
Efficacy of probiotic or postbiotic on incidence of diarrhea or AAD during and after antibiotic therapy as assessed by frequency and form of daily bowel movements measured with Bristol Stool Form Scale (BSFS). BSFS scale ranges from 1 to 7 with scores 1-2 indicating hard and lumpy bowel motions and 6-7 indicating runny, watery stools.
Effects on duration of diarrhea or AAD if presented during the study as compared to placebo.
Efficacy of probiotic or postbiotic on the duration of diarrhea or AAD, if present, as assessed by Bristol Stool Form Scale (BSFS). BSFS scale ranges from 1 to 7 with scores 1-2 indicating hard and lumpy bowel motions and 6-7 indicating runny, watery stools.
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The Archer-Daniels-Midland Company
Lead sponsor
NEXT CRO
Collaborator
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