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NCT04594954

Effects of Fecal Microbiota Transplantation on Weight in Obese Patients With Non-alcoholic Fatty Liver Disease

Status unknown NA Last updated 16 February 2021
What this trial tests

NA trial testing Diet in Non-Alcoholic Fatty Liver Disease in 110 participants. Status unknown.

Timeline
15 October 2020
Primary endpoint
30 September 2021
30 September 2021

Quick facts

Lead sponsorInstitute of Liver and Biliary Sciences, India
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment110
Start date15 October 2020
Primary completion30 September 2021
Estimated completion30 September 2021
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

Adults 18 to 55, any sex, with Non-Alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The worldwide impact of obesity suggests an urgent need for solutions to decrease its burden on modern society. It has been generally understood that obesity is caused by a simple imbalance in the intake of energy in the form of food compared with the expenditure of energy by the body the human microbiota consists of a wide variety of microorganisms, including bacteria, archaea, fungi, viruses, protozoans and yeast. These organisms colonize both the exterior and interior of the human body in numbers that are equivalent to those of human cells of their host. Current research has identified numerous physiological and psycho-modulatory functions of the gut microbiota, including digesting food, stimulating cell growth, strengthening the immune system, preventing allergies and diseases, and impacting emotion. The gut microbiota can contribute to host physiology through metabolite production, such as short-chain fatty acids (SCFAs), which can modulate the intestinal barrier and inflammation 9.Dysbiosis of the gut microbiota, defined as a decrease in commensal bacteria levels and diversity, has been linked to diseases such as stomach/colon/liver cancer 2, obesity 9,inflammatory bowel disease (IBD) and anxiety.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Gut microbiota modulation in patients with non-alcoholic fatty liver disease: Effects of current treatments and future strategies.
    Maestri M, Santopaolo F, Pompili M, Gasbarrini A, et al · · 2023 · cited 52× · PMID 36875849 · DOI 10.3389/fnut.2023.1110536
  2. Gut-Liver-Pancreas Axis Crosstalk in Health and Disease: From the Role of Microbial Metabolites to Innovative Microbiota Manipulating Strategies.
    Marroncini G, Naldi L, Martinelli S, Amedei A. · · 2024 · cited 24× · PMID 39061972 · DOI 10.3390/biomedicines12071398
  3. Pathophysiological Mechanisms in Non-Alcoholic Fatty Liver Disease: From Drivers to Targets.
    Santos-Laso A, Gutiérrez-Larrañaga M, Alonso-Peña M, Medina JM, et al · · 2021 · cited 14× · PMID 35052726 · DOI 10.3390/biomedicines10010046
  4. Faecal Microbiota Transplantation, Paving the Way to Treat Non-Alcoholic Fatty Liver Disease.
    Del Barrio M, Lavín L, Santos-Laso Á, Arias-Loste MT, et al · · 2023 · cited 13× · PMID 37047094 · DOI 10.3390/ijms24076123
  5. Over-feeding the gut microbiome: A scoping review on health implications and therapeutic perspectives.
    Barone M, D'Amico F, Fabbrini M, Rampelli S, et al · · 2021 · cited 12× · PMID 34887627 · DOI 10.3748/wjg.v27.i41.7041
  6. Targeting the Adipose Tissue-Liver-Gut Microbiota Crosstalk to Cure MASLD.
    Gabbia D, De Martin S. · · 2023 · cited 10× · PMID 38132297 · DOI 10.3390/biology12121471
  7. The Roles of Myeloid Cells in Aging-related Liver Diseases.
    Yao J, Li Y, Wang H. · · 2023 · cited 9× · PMID 37056921 · DOI 10.7150/ijbs.82352
  8. Gut microbiome and liver diseases.
    Xu J, Chen N, Li Z, Liu Y. · · 2025 · cited 6× · PMID 40242515 · DOI 10.1016/j.fmre.2024.09.007

Verify or expand the search:

Other trials of Diet

Trials testing the same drug.

Other recruiting trials for Non-Alcoholic Fatty Liver Disease

Currently open trials in the same condition.

Other Institute of Liver and Biliary Sciences, India trials

Trials by the same sponsor.

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