Using washed microbiota transplantation to treat intestinal issues from cancer therapy
Efficacy and Safety of Washed Microbiota Transplantation for the Treatment of Oncotherapy-Related Intestinal Complications
This study is testing whether a treatment that uses healthy gut bacteria can help cancer patients who have stomach problems after their therapy feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT04721041 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of washed microbiota transplantation (WMT) to address intestinal complications that arise from oncotherapy. It focuses on patients with malignant tumors who experience gastrointestinal symptoms after standard cancer treatments. The approach involves the transplantation of processed gut microbiota from healthy donors to restore gut health and potentially improve patient outcomes. The study is designed as a prospective, one-arm, open-label trial to evaluate the efficacy and safety of WMT in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosed malignant tumor who are experiencing gastrointestinal symptoms after cancer treatment.
Not a fit: Patients who are pregnant, have severe cardiopulmonary failure, or have gastrointestinal issues unrelated to cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate gastrointestinal symptoms in cancer patients, improving their quality of life during oncotherapy.
How similar studies have performed: Previous studies have shown promising results for fecal microbiota transplantation in treating gastrointestinal complications related to cancer therapies, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Age ≥18 years old; 2. Diagnosed as malignant tumor; 3. Patients who underwent cancer-related treatment suffering from gastrointestinal symptoms(e.g., abdominal pain, diarrhea, abdominal distension, and difficulty defecating) occurred after standard tumor therapy (such as chemotherapy, radiation, immunotherapy, surgical treatment, etc.); 4. Estimated time of survival ≥ 3 months, and vital signs were stable); 5. Physically qualified and intended to undergo FMT; Exclusion Criteria: * 1\. Patients who were pregnant or nursing; 2. Patients who were unable or unwilling to undergo a gastroscopy or colonoscopy; 3. Patients with cardiopulmonary failure; 4. Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the previous week; 5. history of inflammatory bowel disease and intestinal symptoms unrelated to tumor treatment; 6.Serious uncontrolled diseases and acute infectious diseases；
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
- 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.