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Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis.
Two groups of inpatients with decompensated cirrhosis will be randomized using random sequence generator into experimental and control groups. Two groups will given traditional treatments and experimental group will added treatment with fecal microbiota transplantation via endoscope and/or cenema.The liver function parameters, adverse events complication, systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month and 3 months & subjects will be clinically assessed for improvement or worsening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT | Experimental | Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments |
|
| The traditional treatments | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT | Biological | Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events complication rate in all patients in both groups | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in liver function test as compared to baseline in both groups. | 3 months | |
| Reduction in systemic inflammatory markers like TNF-α in both groups. | 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Zhou, Ph.D | Contact | +86-18981941992 | zqlvzy319@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-an Li, Ph.D | First Affiliated Hospital of Chengdu Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IEC of Chengdu Medical College | Recruiting | Chendu | 610500 | China |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| traditional treatments | Other | traditional treatments for Decompensated Cirrhosis in part 2 |
|
| Reduction in systemic inflammatory markers like IL-6 in both groups. |
Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment. |
| 3 months |
| Reduction in systemic inflammatory markers like serum endotoxins in both groups. | 3 months |
| Diamine oxidase(DAO) | 3 months |
| Histological changes in the intestinal biopsy in both groups. | 3 months |
| Microbiota composition | Deep sequencing of the microbiota at baseline and post-FMT. | 3 months |