Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial.
Adult
Bacteria
/ classification
Cultured Milk Products
/ microbiology
DNA, Bacterial
/ genetics
DNA, Ribosomal
/ genetics
Double-Blind Method
Female
Gastrointestinal Microbiome
/ drug effects
Healthy Volunteers
Humans
Lactobacillus
/ physiology
Lacticaseibacillus rhamnosus
/ physiology
Male
Middle Aged
Phylogeny
Probiotics
/ administration & dosage
RNA, Ribosomal, 16S
/ genetics
Sequence Analysis, DNA
Vital Signs
/ drug effects
Young Adult
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
29 09 2020
29 09 2020
Historique:
received:
09
01
2020
accepted:
24
08
2020
entrez:
30
9
2020
pubmed:
1
10
2020
medline:
13
1
2021
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 32994487
doi: 10.1038/s41598-020-72161-w
pii: 10.1038/s41598-020-72161-w
pmc: PMC7524715
doi:
Substances chimiques
DNA, Bacterial
0
DNA, Ribosomal
0
RNA, Ribosomal, 16S
0
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
15974Références
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