Last reviewed · How we verify

NCT02689245

Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.

Completed NA Last updated 23 November 2018
What this trial tests

NA trial testing Tenofovir in Acute on Chronic Liver Failure in 64 participants. Completed in 13 March 2018.

Timeline
26 February 2016
Primary endpoint
13 March 2018
13 March 2018

Quick facts

Lead sponsorInstitute of Liver and Biliary Sciences, India
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment64
Start date26 February 2016
Primary completion13 March 2018
Estimated completion13 March 2018
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

Adults 18 to 80, any sex, with Acute on Chronic Liver Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated,decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms. Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant). Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.

Publications & conference data

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

  1. Gut microbiome, liver immunology, and liver diseases.
    Wang R, Tang R, Li B, Ma X, et al · · 2021 · cited 297× · PMID 33318628 · DOI 10.1038/s41423-020-00592-6
  2. Bringing microbiome-drug interaction research into the clinic.
    Guthrie L, Kelly L. · · 2019 · cited 48× · PMID 31151933 · DOI 10.1016/j.ebiom.2019.05.009
  3. Advances in Fecal Microbiota Transplantation for Gut Dysbiosis-Related Diseases.
    Hou S, Yu J, Li Y, Zhao D, et al · · 2025 · cited 34× · PMID 40013938 · DOI 10.1002/advs.202413197
  4. Role of Microbiota in Pathogenesis and Management of Viral Hepatitis.
    Sehgal R, Bedi O, Trehanpati N. · · 2020 · cited 34× · PMID 32850467 · DOI 10.3389/fcimb.2020.00341
  5. Clinical Application and Progress of Fecal Microbiota Transplantation in Liver Diseases: A Review.
    Gu X, Lu Q, Zhang C, Tang Z, et al · · 2021 · cited 21× · PMID 34261137 · DOI 10.1055/s-0041-1732319
  6. The role of faecal microbiota transplantation: looking beyond <i>Clostridioides difficile</i> infection.
    D Goldenberg S, Merrick B, Merrick B. · · 2021 · cited 19× · PMID 33614028 · DOI 10.1177/2049936120981526
  7. 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 Tenofovir

Trials testing the same drug.

Other Institute of Liver and Biliary Sciences, India trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02689245.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing