Synbiotics Alter Fecal Microbiomes, But Not Liver Fat or Fibrosis, in a Randomized Trial of Patients With Nonalcoholic Fatty Liver Disease
Open accessAbstract
Background & aims Dysbiosis of the intestinal microbiota has been associated with nonalcoholic fatty liver disease (NAFLD). We investigated whether administration of a synbiotic combination of probiotic and prebiotic agents affected liver fat content, biomarkers of liver fibrosis, and the composition of the fecal microbiome in patients with NAFLD.Methods We performed a double-blind phase 2 trial of 104 patients with NAFLD in the United Kingdom. Participants (mean age, 50.8 ± 12.6 years; 65% men; 37% with diabetes) were randomly assigned to groups given the synbiotic agents (fructo-oligosaccharides, 4 g twice per day, plus Bifidobacterium animalis subspecies lactis BB-12; n = 55) or placebo (n = 49) for 10-14 months. Liver fat content was measured at the start and end of the study by magnetic resonance spectroscopy, and liver fibrosis was determined from a validated biomarker scoring system and vibration-controlled transient elastography. Fecal samples were collected at the start and end of the study, the fecal microbiome were analyzed by 16S ribosomal DNA sequencing.Results Mean baseline and end-of-study magnetic resonance spectroscopy liver fat percentage values were 32.3% ± 24.8% and 28.5% ± 20.1% in the synbiotic group and 31.3% ± 22% and 25.2% ± 17.2% in the placebo group. In the unadjusted intention-to-treat analysis, we found no significant difference in liver fat reduction between groups (β = 2.8; 95% confidence interval, -2.2 to 7.8; P = .30). In a fully adjusted regression model (adjusted for baseline measurement of the outcome plus age, sex, weight difference, and baseline weight), only weight loss was associated with a significant decrease in liver fat (β = 2; 95% confidence interval, 1.5-2.6; P = .03). Fecal samples from patients who received the synbiotic had higher proportions of Bifidobacterium and Faecalibacterium species, and reductions in Oscillibacter and Alistipes species, compared with baseline; these changes were not observed in the placebo group. Changes in the composition of fecal microbiota were not associated with liver fat or markers of fibrosis.Conclusions In a randomized trial of patients with NAFLD, 1 year of administration of a synbiotic combination (probiotic and prebiotic) altered the fecal microbiome but did not reduce liver fat content or markers of liver fibrosis. (ClinicalTrials.gov, Number: NCT01680640).
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A synbiotic formation failed to alter fibrosis in another study.
“Transplant of fecal microbiota from lean healthy donors into obese patients improved lipid profiles and reduced liver stiffness in one study (200), whereas in another a synbiotic formation (probiotics + prebiotics) failed to alter fibrosis (201).”
From Found in translation—Fibrosis in metabolic dysfunction–associated steatohepatitis (MASH) (2023) · cites this paper as [201]
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- Authors
- Scorletti, E., Afolabi, P. R., Miles, E. A., Smith, D. E., Almehmadi, A., Alshathry, A., Childs, C. E., Del Fabbro, S., Bilson, J., Moyses, H. E., Clough, G. F., Sethi, J. K., Patel, J., Wright, M., Breen, D. J., Peebles, C., Darekar, A., Aspinall, R., Fowell, A. J., Dowman, J. K., Nobili, V., Targher, G., Delzenne, N. M., Bindels, L. B., Calder, P. C., & Byrne, C. D.
- Affiliations
- National Health Service (GB)
- University of Southampton (GB)
- University of Verona (IT)
- UCLouvain (BE)
- Corresponding author
- Scorletti, Eleonora
- ORCID
- Scorletti, Eleonora
- Afolabi, Paul R.
- Miles, Elizabeth A.
- Smith, Debbie E.
- Alshathry, Albandri
- Childs, Caroline E.
- Bilson, Josh
- Moyses, Helen E.
- Clough, Geraldine F.
- Sethi, Jaswinder K.
- Patel, Janisha
- Wright, Mark
- Breen, David J.
- Peebles, Charles
- Darekar, Angela
- Aspinall, Richard
- Fowell, Andrew J.
- Targher, Giovanni
- Delzenne, Nathalie M.
- Bindels, Laure B.
- Calder, Philip C.
- Byrne, Christopher D.
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2020-05
- Volume
- 158
- Issue
- 6
- Pages
- 1597-1610.e7
- ISSN
- 0016-5085 (ISSN-L)
- PMC
- PMC7613160
- OpenAlex
- W3000749615
- Cited by
- 237
- References
- 73
- Citations by year
- 2026: 35 · 2025: 36 · 2024: 45 · 2023: 42 · 2022: 29 · 2021: 33 · 2020: 17
- FWCI
- 21.67
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- ePrints Soton (University of Southampton) (submittedVersion)
- Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion, other-oa)
- Funders
- Université Catholique de Louvain
- Wellcome Trust (206453/Z/17/Z)
- National Institute for Health and Care Research
- National Institute for Health Research Southampton Biomedical Research Centre
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Keywords
- synbiotics, non-alcoholic fatty liver disease, fructooligosaccharides, Bifidobacterium animalis subsp. lactis BB-12, probiotics, prebiotics, fecal microbiota, liver fat, liver fibrosis, dysbiosis, weight loss, Oscillibacter, Faecalibacterium, Alistipes
- MeSH terms
- Gastrointestinal Microbiome, Bifidobacterium animalis, Proof of Concept Study, Adult, Biopsy, Double-Blind Method, Feces, Female, United Kingdom, Humans, Lipids, Liver, Liver Cirrhosis, Male, Middle Aged, Magnetic Resonance Spectroscopy, Oligosaccharides, Biomarkers, Elasticity Imaging Techniques, Synbiotics, Dysbiosis, Non-alcoholic Fatty Liver Disease
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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