Evidence map›Paper›PMID 31423319›Full record

ArticleBMJ open gastroenterology2019

High potency multistrain probiotic improves liver histology in non-alcoholic fatty liver disease (NAFLD): a randomised, double-blind, proof of concept study.

Ajay Duseja, Subrat K Acharya, Manu Mehta, Shruti Chhabra, Shalimar, Satyavati Rana, Ashim Das, Siddhartha Dattagupta, Radha K Dhiman, Yogesh K Chawla

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07025980 (Effect of Sinbiotic With Multispecies Probiotics on Liver Parameters in Patients With Metabolic Associated Steatotic Liver Disease), which is not on this map. Cited by 74 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 12 pooled it
10.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07025980 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Effect of Sinbiotic With Multispecies Probiotics on Liver Parameters in Patients With Metabolic Associated Steatotic Liver Disease

TypeinterventionalSponsorEva CubricRan2025 to 2029Enrolled114ConditionsMASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Diabetes Mellitus, Hypertension, HyperlipidaemiaArmsThe test product is a ready-to-use sinbiotic preparation of multispecies probiotics, ca-butyrate and FOS, Placebo Drug
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 12 syntheses or guidelines pooled it, 138 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Gut Microbiota and Liver Health: Meta-Analysis ofInternational journal of molecular sciences · 2025
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Effect of Probiotics Therapy on Nonalcoholic Fatty Liver Disease.Computational and mathematical methods in medicine · 2022
    Pooled it
  11. Pooled it
  12. Pooled it
  13. Trial
  14. Effects ofWorld journal of gastroenterology · 2024
    Trial
  15. Trial
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review

14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Ajay DusejaDepartment of Hepatology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.ORCID 0000-0003-3590-2664
Subrat K AcharyaDepartment of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
Manu MehtaDepartment of Hepatology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Shruti ChhabraDepartment of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
Shalimar
Satyavati RanaDepartment of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Ashim DasDepartment of Histopathology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Siddhartha DattaguptaDepartment of Pathology, All India Institute of Medical Sciences, New Delhi, India.
Radha K DhimanDepartment of Hepatology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Yogesh K ChawlaDepartment of Hepatology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Post Graduate Institute of Medical Education and Research · INAll India Institute of Medical Sciences · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePharmacological treatment of non-alcoholic fatty liver disease (NAFLD) is still evolving. Probiotics could be a promising treatment option, but their effectiveness needs to be established. The present study aimed to evaluate the efficacy of a high potency multistrain probiotic in adult patients with NAFLD.

methodsThirty-nine liver biopsy-proven patients with NAFLD were randomised in a double-blind fashion to either lifestyle modifications plus an oral multistrain probiotic (675 billion bacteria daily, n=19) or identical placebo (n=20) for 1 year. Lifestyle modifications included regular exercise for all and control of overweight/obesity (with additional dietary restrictions), hypertension and hyperlipidaemia in those with these risk factors. Primary objective of the study was the histological improvement in NAFLD activity score (NAS) and its components and secondary objectives were improvement in alanine transaminase (ALT) and cytokine profile.

resultsThirty (76.9%) out of 39 patients with NAFLD completed the study with 1 year of follow-up. A repeat liver biopsy at 1 year could be done in 10 patients (52.6%) in probiotic group and five patients (25%) in placebo group. In comparison to baseline, hepatocyte ballooning (p=0.036), lobular inflammation (p=0.003) and NAS score (p=0.007) improved significantly at 1 year in the probiotic group. When compared with placebo, the NAS score improved significantly in the probiotic group (p=0.004), along with improvements in hepatocyte ballooning (p=0.05) and hepatic fibrosis (p=0.018). A significant improvement in levels of ALT (p=0.046), leptin (p=0.006), tumour necrosis factor-α (p=0.016) and endotoxins (p=0.017) was observed in probiotic group in comparison to placebo at 1 year. No significant adverse events were reported in the study.

conclusionPatients with NAFLD managed with lifestyle modifications and multistrain probiotic showed significant improvement in liver histology, ALT and cytokines. TRIAL REGISTRATION NUMBER: The clinical trial is registered with CLINICAL TRIAL REGISTRYINDIA (CTRI); http://ctri.nic.in, No. CTRI/2008/091/000074.

Indexed as

bacterial overgrowthfatty liverhepatic steatosismetabolic syndromemicrobiotaNASHnon-alcoholic steatohepatitis

Identifiers

PMID31423319
PMCPMC6688701
OpenAlexW2967413643

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.