Fecal Microbiota Transplantation for Decompensated Cirrhosis (FMTDC)
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|ClinicalTrials.gov Identifier: NCT03014505|
Recruitment Status : Unknown
Verified January 2017 by First Affiliated Hospital of Chengdu Medical College.
Recruitment status was: Recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Decompensated Cirrhosis Fecal Microbiota Transplantation||Biological: FMT Other: traditional treatments||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||July 2018|
Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments
Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1
Other Name: Fecal Microbiota Transplantation
|Active Comparator: The traditional treatments||
Other: traditional treatments
traditional treatments for Decompensated Cirrhosis in part 2
- Number of adverse events complication rate in all patients in both groups [ Time Frame: 3 months ]Adverse events like the general situation, defecate situation and possible clinical events, including: Incidence of new onset upper gastrointestinal bleed in both groups; development of new onset of ascites in both groups.; Number of Spontaneous Bacterial peritonitis cases in both groups. Acute on Chronic Liver failure cases in both groups.
- Improvement in liver function test as compared to baseline in both groups. [ Time Frame: 3 months ]
- Reduction in systemic inflammatory markers like TNF-α in both groups. [ Time Frame: 3 months ]
- Reduction in systemic inflammatory markers like IL-6 in both groups. [ Time Frame: 3 months ]Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.
- Reduction in systemic inflammatory markers like serum endotoxins in both groups. [ Time Frame: 3 months ]
- Diamine oxidase（DAO） [ Time Frame: 3 months ]
- Histological changes in the intestinal biopsy in both groups. [ Time Frame: 3 months ]
- Microbiota composition [ Time Frame: 3 months ]Deep sequencing of the microbiota at baseline and post-FMT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014505
|Contact: Yan Zhou, Ph.Dfirstname.lastname@example.org|
|IEC of Chengdu Medical College||Recruiting|
|Chendu, China, 610500|
|Contact: Xiao-an Li, doctor +8613680868858 email@example.com|
|Study Chair:||Xiao-an Li, Ph.D||First Affiliated Hospital of Chengdu Medical College|