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Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial.

ABSTRACT: Many clinical studies have evaluated the effect of probiotics, but only a few have assessed their dose effects on gut microbiota and host. We conducted a randomized, double-blind, controlled intervention clinical trial to assess the safety (primary endpoint) of and gut microbiota response (secondary endpoint) to the daily ingestion for 4 weeks of two doses (1 or 3 bottles/day) of a fermented milk product (Test) in 96 healthy adults. The Test product is a multi-strain fermented milk product, combining yogurt strains and probiotic candidate strains Lactobacillus paracasei subsp. paracasei CNCM I-1518 and CNCM I-3689 and Lactobacillus rhamnosus CNCM I-3690. We assessed the safety of the Test product on the following parameters: adverse events, vital signs, hematological and metabolic profile, hepatic, kidney or thyroid function, inflammatory markers, bowel habits and digestive symptoms. We explored the longitudinal gut microbiota response to product consumption and dose, by 16S rRNA gene sequencing and functional contribution by shotgun metagenomics. Safety results did not show any significant difference between the Test and Control products whatever the parameters assessed, at the two doses ingested daily over a 4-week-period. Probiotic candidate strains were detected only during consumption period, and at a significantly higher level for the three strains in subjects who consumed 3 products bottles/day. The global structure of the gut microbiota as assessed by alpha and beta-diversity, was not altered by consumption of the product for four weeks. A zero-inflated beta regression model with random effects (ZIBR) identified a few bacterial genera with differential responses to test product consumption dose compared to control. Shotgun metagenomics analysis revealed a functional contribution to the gut microbiome of probiotic candidates.

SUBMITTER: Alvarez AS

PROVIDER: S-EPMC7524715 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial.

Alvarez Anne-Sophie AS Tap Julien J Chambaud Isabelle I Cools-Portier Stéphanie S Quinquis Laurent L Bourlioux Pierre P Marteau Philippe P Guillemard Eric E Schrezenmeir Juergen J Derrien Muriel M

Scientific reports 20200929 1

Many clinical studies have evaluated the effect of probiotics, but only a few have assessed their dose effects on gut microbiota and host. We conducted a randomized, double-blind, controlled intervention clinical trial to assess the safety (primary endpoint) of and gut microbiota response (secondary endpoint) to the daily ingestion for 4 weeks of two doses (1 or 3 bottles/day) of a fermented milk product (Test) in 96 healthy adults. The Test product is a multi-strain fermented milk product, comb ...[more]

PMID: 32994487

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Project description:Abstract Objectives The first year of life is a critical window for appropriate enteric microbiome development. Variations in infant diets have persistent effects on gut microbial ecology. Compared to intact protein formulas (IPF), partially hydrolyzed infant formulas (PHF) contain broken down milk proteins and may impact development of atopic conditions in high-risk infants. However, the effects of PHFs on the developing gut microbiome are not known. Methods This study was a secondary analysis of the GLOWING study (ClinicalTrials.gov NCT01131117). Infant stool samples were collected at 6 months of age and microbial composition was examined via 16S rRNA amplicon sequencing (V4 region) using standardized methods. Samples were grouped by primary feeding type: Exclusive breastfeeding (BF; n = 42), IPF (n = 17), or PHF (n = 12). We used linear models to examine the effects of feeding type adjusting for lifetime breastfeeding exposure at 6 mo. Group differences in α-diversity (richness and diversity) and relative abundances were assessed by ANOVA or t-test. Between-specimen diversity (β-diversity) was assessed using Bray − Curtis dissimilarities. Results Total breast milk exposure did not differ between PHF and IPF (mean 32.3% of feeds from human milk, p = 0.08). Analysis of α-diversity showed higher evenness (Shannon, Simpson) in IPF and higher richness (Chao1, Observed OTU) in PHF. However, these differences were no longer significant after adjusting for breastmilk exposure. β-diversity did not differ between groups. At the genus level compared to BF, infants fed IPF had higher abundance of Parabacteroides, while those fed PHF had higher Erwinia and Clostridium. Peptostreptococcaceae family was also increased in PHF fed infants. Compared to IPF, the PHF group had higher abundance of Clostridium genus, and Peptostreptococcaceae and Enterobacteriaceae families. Elevated Enterobacteriaceae and Clostridiales have previously been found in children with food allergies. Conclusions Our results suggest that partially hydrolyzed infant formulas may have modest impacts on the gut microbiome compared to intact protein formulas. Larger samples sizes are needed to fully characterize these differences and potential influence on long-term health. Funding Sources U.S. Department of Agriculture, NIDDK.

Project description:Background: Prebiotics, defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit, present a potential option to optimize gut microbiome health. Elucidating the relationship between specific intestinal bacteria, prebiotic intake, and the health of the host remains a primary microbiome research goal.Objective: To assess the correlations between gut microbiota, serum health parameters, and prebiotic consumption in healthy adults.Methods: We performed ad hoc exploratory analysis of changes in abundance of genera in the gut microbiome of 75 participants from a randomized, placebo-controlled clinical trial that evaluated the effects of resistant potato starch (RPS; MSPrebiotic®, N =?38) intervention versus a fully digestible placebo (N =?37) for which primary and secondary outcomes have previously been published. Pearson correlation analysis was used to identify relationships between health parameters (ie. blood glucose and lipids) and populations of gut bacteria.Results: Abundance of Parasutterella (phylum Proteobacteria) tended to increase in the gut microbiome of individuals consuming RPS and those increases in Parasutterella were correlated with reductions in low-density lipoprotein (LDL) levels in participants consuming RPS but not placebo. Segregating RPS-consuming individuals whose LDL levels decreased (ie "Responders") from those who did not (ie. "Non-Responders") revealed that LDL Responders had significantly higher levels of Parasutterella both at baseline and after 12?weeks of consuming RPS.Conclusion: Our analyses suggest that RPS may help improve LDL levels depending upon the levels of Parasutterella in an individual's gut microbiome.Trial registration: This study protocol was reviewed and approved by Health Canada (Submission #188517; "Notice of Authorization" dated 06/05/13) and registered as NCT01977183 (10/11/13) listed on NIH website: ClinicalTrials.gov. Data generated in this study have been submitted to NCBI ( http://www.ncbi.nlm.nih.gov/bioproject/381931 ).Funding: MSP Starch Products Inc.

Dataset Information

Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial.

Publications

Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial.

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