Fecal microbiota transplantation for treating radiation enteritis
Efficacy and Safety of Fecal Microbiota Transplantation in Radiation Enteritis
This study is testing if a treatment called fecal microbiota transplantation can help people with radiation enteritis feel better after their cancer treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT03516461 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of fecal microbiota transplantation (FMT) in patients suffering from radiation enteritis, a complication following abdominal or pelvic radiation therapy. The study involves re-establishing gut functionality through FMT, with a focus on patient involvement in health decisions via a 'Shared Decision Making' approach. Participants will undergo assessments including blood tests, endoscopy, and questionnaires at the start and completion of the study, with follow-up lasting at least 12 weeks. The trial aims to analyze changes in fecal microbiota compositions and metabolic profiles associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with radiation enteritis confirmed by colonoscopy after completing radiotherapy.
Not a fit: Patients who are pregnant, nursing, or have gastrointestinal infections or severe cardiopulmonary failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from radiation enteritis.
How similar studies have performed: Previous studies have shown promising results with fecal microbiota transplantation in various gastrointestinal conditions, suggesting potential success for this approach in radiation enteritis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age ≥18 years old; 2. Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy. Exclusion Criteria: 1. Patients who were pregnant or nursing; 2. Patients who were unable or unwilling to undergo a gastroscopy; 3. Patients who had gastrointestinal infection; 4. Patients with cardiopulmonary failure.
Where this trial is running
Nanjing, Jiangsu
- Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Faming Zhang, MD; PHD — The Second Hospital of Nanjing Medical University
- Study coordinator: Faming Zhang, MD; PHD
- Email: fzhang@njmu.edu.cn
- Phone: 086-25-58509883
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.