Fecal microbiota transplantation for Crohn's disease
Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases
This study is testing whether a treatment called fecal microbiota transplantation can help people with Crohn's disease feel better by restoring the balance of good bacteria in their gut.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 2 sites (Huai'an, Jiangsu and 1 other locations) |
| Trial ID | NCT01793831 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of fecal microbiota transplantation (FMT) as a treatment for Crohn's disease, aiming to restore gut microbiota functionality. The study will involve at least 500 patients who will receive either FMT or traditional treatments, with follow-up assessments including blood tests, imaging, and endoscopy over a period of ten years. The microbiota will be isolated from donated stool and transplanted into patients' intestines using established methods. The goal is to evaluate the effectiveness, durability, and safety of FMT in managing Crohn's disease.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Crohn's disease who have not responded to traditional treatments and are willing to undergo FMT.
Not a fit: Patients with serious underlying conditions such as malignant neoplasms or severe organ failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Crohn's disease, potentially improving their quality of life.
How similar studies have performed: Preliminary studies have shown some success with fecal microbiota transplantation for inflammatory bowel diseases, but results specifically for Crohn's disease are limited, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Huai'an, Jiangsu and 1 other locations
- The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University — Huai'an, Jiangsu, China (Recruiting)
- Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Faming Zhang, MD, PhD
- Email: fzhang@njmu.edu.cn
- Phone: 86-025-58509883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.