Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

Study Overview
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Brief Summary
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The gut microbiota is considered to constitute a microbial organ which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

Detailed Description
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The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System.

Official Title
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Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis

Conditions
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Bacteria, Microbiota, Fecal Microbiota Transplantation, Inflammatory Bowel Disease, Ulcerative Colitis

Intervention / Treatment
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* Procedure: Standardized FMT
* Drug: Traditional treatments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC from the previous therapies. Exclusion Criteria: Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized FMT<br>endoscopy Tubing Once or repeat | Procedure: Standardized FMT<br>* Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon<br>* Other names: fecal transplantation;|
| Experimental: Traditional treatments<br>Oral Tubing | Drug: Traditional treatments<br>* Medications<br>* Other names: Traditional treatments according to associated guidelines;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of FMT | The efficacy and durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission) | On year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number and severity of adverse events | Ten years | 
| sleep quality | evaluated by PSQI | before FMT and 1 month after FMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut bacteria, Gut flora, Bacteriotherapy, Fecal Microbiota Transplantation, Inflammatory bowel disease, Ulcerative colitis