Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

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 (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This is an initial step into investigating the potential efficacy of fecal bacteriotherapy for CD, the investigators propose to determine the efficiency, durability and safety of FMT in a series of 500 patients with CD in ten years.

Detailed Description
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The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for CD (all age range,HBI>4). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to mid-gut (at least below the duodenal papilla) through regular gastroscope. Patients from multi-clinical centers in this study will be assigned to receive FMT only once or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests, abdominal X-ray, endoscopy and questionnaire will be used to assess participants at study start and at study completion.

Official Title
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Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases

Conditions
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Crohn's Diseases, Inflammatory Bowel Disease

Intervention / Treatment
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* Procedure: FMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who had been diagnosed with CD through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, patients with inactive and active CD and patients who failed to achieve satisfactory efficacy for CD 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal microbiota transplantation<br>Standard fecal microbiota transplantation, once. | Procedure: FMT<br>* Standard FMT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission | Clinical remission defined as HBI score ≦ 4. The endpoint of follow-up is the time of clinical recurrence. | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs | Social and medical costs | Up to one year | 
| Adverse events | All possible adverse events:fever,abdominal pain,infectious diseases and others | During FMT and ten years after FMT | 
| sleep quality | evaluated by PSQI | before FMT, 1 month after FMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's diseases, Inflammatory bowel disease, Fecal transplantation, Fecal bacteriotherapy, Fecal microbiota transplantation