Standardized Fecal Microbiota Transplantation for Crohn's Diseases
- Conditions
- Inflammatory Bowel DiseaseCrohn's Disease (CD)
- Interventions
- Procedure: FMT
- Registration Number
- NCT01793831
- Lead Sponsor
- The Second Hospital of Nanjing Medical University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
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).
Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fecal microbiota transplantation FMT Standard fecal microbiota transplantation, which has been defined as washed microbiota transplantation since 2019.
- Primary Outcome Measures
Name Time Method Clinical remission Up to one year Clinical remission defined as HBI score ≦ 4. For patients with complications such as intestinal obstruction, Clinical remission can be defined as obstruction improvement. The endpoint of follow-up is the time of clinical recurrence.
- Secondary Outcome Measures
Name Time Method Costs Up to one year Social and medical costs
Symptomatic stricture before FMT, 1 month after FMT, 12 weeks after FMT evaluated by Crohn's Disease Obstruction Score (CDOS), with a score range of 0 to 6. Higher scores indicate greater severity of obstructive symptoms.
Sleep quality before FMT, 1 month after FMT, 12 weeks after FMT evaluated by Pittsburgh Sleep Quality Index (PSQI), with a score range of 0 to 21. Higher PSQI score indicates poorer sleep quality. Insomnia Severity Index (ISI), with a score range of 0 to 28. Higher ISI score indicates more severe insomnia.
Adverse events During FMT and ten years after FMT All possible adverse events:fever,abdominal pain,infectious diseases and others
Fatigue before FMT, 1 month after FMT, 12 weeks after FMT evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), with a score range of 0 to 52. Higher FACIT-F score indicates lower levels of fatigue and better quality of life.
Anxiety and depression before FMT, 1 month after FMT, 12 weeks after FMT evaluated by Hospital Anxiety and Depression Scale (HADS), with a score range of 0 to 42. Higher scores indicate greater severity of anxiety and depression symptoms.
Trial Locations
- Locations (2)
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
🇨🇳Huai'an, Jiangsu, China
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China