Clinical trial NCT01793831: Standardized Fecal Microbiota Transplantation for Crohn's Diseases
Official title: Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn's Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease
Crohn&#39;s Disease (CD)
Keywords: Inflammatory bowel disease
Fecal transplantation
Fecal bacteriotherapy
Fecal microbiota transplantation
Crohn&amp;#39;s disease
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University
name: The First Affiliated Hospital of Air Force Medicial University
First posted: 2013-02-18
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 fecal microbiota transplantation (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 marks the initial step in exploring the potential efficacy of fecal bacteriotherapy for CD. The investigators aim to evaluate the effectiveness, durability, and safety of FMT in a cohort of at least 500 patients with CD over a ten-year period

Detailed description: 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. The microbiota is then transplanted into the intestine via endoscopy or other established methods, such as mid-gut or colonic transendoscopic enteral tubing. Patients from multi-clinical centers in this study will be assigned to receive FMT or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests, imaging, endoscopy and questionnaire will be used to assess participants at study start and at study completion.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Crohn's disease, with the diagnosis remaining unchanged after at least three months of follow-up.

Willingness to undergo FMT (Fecal Microbiota Transplantation).

Exclusion Criteria:

Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).

Primary outcomes:
measure: Clinical remission
timeFrame: Up to one year
Secondary outcomes:
measure: Costs
timeFrame: Up to one year
measure: Adverse events
timeFrame: During FMT and ten years after FMT
measure: Sleep quality
timeFrame: before FMT, 1 month after FMT, 12 weeks after FMT
measure: Fatigue
timeFrame: before FMT, 1 month after FMT, 12 weeks after FMT
measure: Anxiety and depression
timeFrame: before FMT, 1 month after FMT, 12 weeks after FMT
measure: Symptomatic stricture
timeFrame: before FMT, 1 month after FMT, 12 weeks after FMT
Other outcomes:
Locations:
city: Huai'an
country: China
facility: The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
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