Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial
Open accessAbstract
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.
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In humans, consumption of a fermented dairy drink for 4 weeks increased the abundance of a few specific genera and enriched some functions of the resident microbes.
“In another recent human study, consumption of a fermented dairy drink for 4 wk increased the abundance of a few specific genera (e.g., Holdemania, Gordonibacter, Lactobacillus, an unclassified Mollicutes (RF-9), and two unclassified genera from Clostridiales), and enriched some functions of the resident microbes (195).”
From Diet and the Microbiota–Gut–Brain Axis: Sowing the Seeds of Good Mental Health (2021) · cites this paper as [195]
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Cholesterol transport in blood, lipoproteins, and cholesterol metabolism
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- Authors
- Alvarez, A.-S., Tap, J., Chambaud, I., Cools-Portier, S., Quinquis, L., Bourlioux, P., Marteau, P., Guillemard, E., Schrezenmeir, J., & Derrien, M.
- Affiliations
- Danone (France) (FR)
- Université Paris-Sud (FR)
- Inserm (FR)
- Clinical Research Center Kiel (DE)
- Corresponding author
- Derrien, Muriel
- ORCID
- Venue
- Scientific Reports
- Published
- 2020-09-29
- Volume
- 10
- Issue
- 1
- Pages
- 15974-15974
- ISSN
- 2045-2322 (ISSN-L)
- OpenAlex
- W3090666421
- Cited by
- 36
- References
- 68
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 6 · 2023: 5 · 2022: 6 · 2021: 7 · 2020: 1
- FWCI
- 3.08
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Scientific Reports (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HAL (submittedVersion, other-oa)
- Funders
- Danone
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Keywords
- probiotics, Lacticaseibacillus paracasei subsp. paracasei, Lactobacillus rhamnosus, dosage effect, gut microbiota, probiotic safety, functional enrichment, alpha and beta diversity, zero-inflated beta regression, healthy adults
- MeSH terms
- Gastrointestinal Microbiome, Lacticaseibacillus paracasei, Adult, Bacteria, DNA, Bacterial, DNA, Ribosomal, Double-Blind Method, Female, Humans, Lactobacillus, Male, Middle Aged, Phylogeny, RNA, Ribosomal, 16S, Sequence Analysis, DNA, Probiotics, Cultured Milk Products, Lacticaseibacillus rhamnosus, Young Adult, Vital Signs, Healthy Volunteers
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