Evidence map›Paper›PMID 38315140›Full record

Trial reportHepatology communications2024

The RIVET RCT: Rifamycin SV MMX improves muscle mass, physical function, and ammonia in cirrhosis and minimal encephalopathy.

Jasmohan S Bajaj, Andrew Fagan, Edith A Gavis, Travis Mousel, Mary L Gallagher, Puneet Puri, Michael Fuchs, Brian C Davis, Phillip B Hylemon, Huiping Zhou and 4 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Hepatology communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. [Chinese guidelines for clinical diagnosis, treatment, and management of cirrhosis (2025)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Guideline
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Microbial Approaches to Treat and Prevent Hepatic Encephalopathy.Gastroenterology clinics of North America · 2025
    Review
  10. Article
  11. Article
  12. Chinese Guidelines on the Management of Hepatic Encephalopathy in Cirrhosis (2024).Journal of clinical and translational hepatology · 2025
    Article
  13. Article
  14. Article
  15. [Chinese guidelines on the management of hepatic encephalopathy in cirrhosis (2024)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
    Article
  16. Article
  17. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Jasmohan S BajajDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.ORCID 0000-0003-4928-3681
Andrew FaganDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Edith A GavisDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Travis MouselDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Mary L GallagherDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Puneet PuriDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Michael FuchsDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Brian C DavisDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Phillip B HylemonDepartment of Microbiology and Immunology, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Huiping ZhouDepartment of Microbiology and Immunology, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Vishwadeep AhluwaliaDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University and Richmond VA Medical Center, Richmond, Virginia, USA.
Robert CadrainCollaborative Advanced Research Imaging Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Masoumeh SikaroodiMicrobiome Analysis Center, George Mason University, Manassas, Virginia, USA.
Patrick M GillevetMicrobiome Analysis Center, George Mason University, Manassas, Virginia, USA.

Funding

Bile Acids and Sphingosine 1-Phosphate in Non-Alcoholic Steatohepatitis (NASH)I01BX005730 · VA · VA VETERANS ADMINISTRATION HOSPITAL · PI HUIPING ZHOU · 2023 to 2026
–
BLR&D Research Career Scientist Award ApplicationIK6BX004477 · VA · VA VETERANS ADMINISTRATION HOSPITAL · PI HUIPING ZHOU · 2019 to 2026
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The ShEEP request for Waters Xevo TQ-XS Liquid Chromatography Mass Spectrometer SystemIS1BX004777 · VA · VA VETERANS ADMINISTRATION HOSPITAL · PI ZHOU, HUIPING ROSE · 2019 to 2019
–
BLRD VA I01 BX005730BLRD VA IK6 BX004477BLRD VA IS1 BX004777
6 · The paper itself

Abstract

backgroundMinimal hepatic encephalopathy (MHE) negatively affects the prognosis of cirrhosis, but treatment is not standard. Rifamycin SV MMX (RiVM) is a nonabsorbable rifampin derivative with colonic action.

methodsIn a phase 2 placebo-controlled, double-blind randomized clinical trial patients with MHE were randomized to RiVM or placebo for 30 days with a 7-day follow-up. The primary endpoint was a change in stool cirrhosis dysbiosis ratio. Gut-brain (cognition, stool/salivary microbiome, ammonia, brain magnetic resonance spectroscopy), inflammation (stool calprotectin/serum cytokines), patient-reported outcomes (sickness impact profile: total/physical/psychosocial, high = worse), and sarcopenia (handgrip, bioelectric impedance) were secondary. Between/within groups and delta (post-pre) comparisons were performed.

resultsThirty patients (15/group) were randomized and completed the study without safety concerns. While cirrhosis dysbiosis ratio was statistically similar on repeated measures ANOVA (95% CI: -0.70 to 3.5), ammonia significantly reduced (95% CI: 4.4-29.6) in RiVM with changes in stool microbial α/β-diversity. MHE status was unchanged but only serial dotting (which tests motor strength) improved in RiVM-assigned patients. Delta physical sickness impact profile (95% CI: 0.33 = 8.5), lean mass (95% CI: -3.3 to -0.9), and handgrip strength (95% CI: -8.1 to -1.0) improved in RiVM versus placebo. Stool short-chain fatty acids (propionate, acetate, and butyrate) increased post-RiVM. Serum, urine, and stool bile acid profile changed to nontoxic bile acids (higher hyocholate/ursodeoxycholate and lower deoxycholate/lithocholate) post-RiVM. Serum IL-1β and stool calprotectin decreased while brain magnetic resonance spectroscopy showed higher glutathione concentrations in RiVM.

conclusionsRiVM is well tolerated in patients with MHE with changes in stool microbial composition and function, ammonia, inflammation, brain oxidative stress, and sarcopenia-related parameters without improvement in cognition. RiVM modulates the gut-brain axis and gut-muscle axis in cirrhosis.

Indexed as

Hepatic EncephalopathyRifamycinsSarcopeniaAmmoniaDysbiosisHand StrengthHumansInflammationLeukocyte L1 Antigen ComplexLiver CirrhosisMusclesAmmoniaLeukocyte L1 Antigen ComplexRifamycinsrifamycin SV

Identifiers

PMID38315140
PMCPMC10843468

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.