drugset / Trial / NCT03152188
Oral Fecal Transplant in Cirrhosis
Phase 1
Completed
20 enrolled
Virginia Commonwealth University
Hunter Holmes McGuire VA Medical Center · collabMedical College of Wisconsin · collabNational Institutes of Health (NIH) · collabOpenBiome · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
To evaluate the safety and tolerability of oral fecal transplant in patients with cirrhosis and hepatic encephalopathy
Timeline
- Start
- 2017-06-12
- Primary completion
- 2018-11-12
- Completion
- 2018-11-12
Publications
- Bajaj JS, Salzman N, Acharya C, Takei H, Kakiyama G, Fagan A, White MB, Gavis EA, Holtz ML, Hayward M, Nittono H, Hylemon PB, Cox IJ, Williams R, Taylor-Robinson SD, Sterling RK, Matherly SC, Fuchs M, Lee H, Puri P, Stravitz RT, Sanyal AJ, Ajayi L, Le Guennec A, Atkinson RA, Siddiqui MS, Luketic V, Pandak WM, Sikaroodi M, Gillevet PM. Microbial functional change is linked with clinical outcomes after capsular fecal transplant in cirrhosis. JCI Insight. 2019 Dec 19;4(24):e133410. doi: 10.1172/jci.insight.133410.
- Bajaj JS, Salzman NH, Acharya C, Sterling RK, White MB, Gavis EA, Fagan A, Hayward M, Holtz ML, Matherly S, Lee H, Osman M, Siddiqui MS, Fuchs M, Puri P, Sikaroodi M, Gillevet PM. Fecal Microbial Transplant Capsules Are Safe in Hepatic Encephalopathy: A Phase 1, Randomized, Placebo-Controlled Trial. Hepatology. 2019 Nov;70(5):1690-1703. doi: 10.1002/hep.30690. Epub 2019 Jun 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fecal microbial transplant | Other / unclassified | 15 unknown | Oral |