Clinical trial · Interventional
Washed Microbiota Transplantation for the Treatment of Oncotherapy-Related Intestinal Complications
Efficacy and Safety of Washed Microbiota Transplantation for the Treatment of Oncotherapy-Related Intestinal Complications
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gut microbiota, known as "unrecognized organs", is closely related to the occurrence and development of tumors. Cancer is thought to occur secondary to local chronic inflammation. And some bacteria, such as Helicobacter pylori, also have direct genotoxicity, changing intracellular signaling pathways and thus causing abnormal cell growth. Systemic intestinal dysbiosis may lead to cancer, and fecal microbiota transplantation (FMT) can be a new weapon in anti-cancer treatment.Washed microbiota transplantation (WMT), a new stage of FMT, is based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following repeated centrifugation plus suspension with support from specific facilities. The investigators conducted a prospective, one-arm, open-label study on the efficacy and safety of WMT in the treatment of oncotherapy-related complications. This study aimed to exploring the therapeutic potential of WMT in the treatment of oncotherapy-related intestinal complications and improving the quality of life of patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Intestinal Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Washed Microbiota Transplantation (WMT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Washed Microbiota Transplantation (WMT)
- description
- Patients undergo once WMT a day for three consecutive days.
- interventionNames
- Other: Washed Microbiota Transplantation (WMT)
- type
- NO_INTERVENTION
- label
- Basic treatment
- description
- Basic treatment based on the lastest clinical guidelines
Primary outcomes (2)
- measure
- Scores of gastrointestinal symptoms
- timeFrame
- 8 weeks
- description
- Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (4)
- BACKGROUNDPrisciandaro M, Ratta R, Massari F, Fornarini G, Caponnetto S, Iacovelli R, De Giorgi U, Facchini G, Scagliarini S, Sabbatini R, Caserta C, Peverelli G, Mennitto A, Verzoni E, Procopio G. Safety and Efficacy of Cabozantinib for Metastatic Nonclear Renal Cell Carcinoma: Real-world Data From an Italian Managed Access Program. Am J Clin Oncol. 2019 Jan;42(1):42-45. doi: 10.1097/COC.0000000000000478. PMID 30204614
- BACKGROUNDSurawicz CM, Brandt LJ, Binion DG, Ananthakrishnan AN, Curry SR, Gilligan PH, McFarland LV, Mellow M, Zuckerbraun BS. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013 Apr;108(4):478-98; quiz 499. doi: 10.1038/ajg.2013.4. Epub 2013 Feb 26. PMID 23439232
- BACKGROUNDZhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9. PMID 31919742
- DERIVEDWang W, He X, Liang C, Wang Y, Yu Y, Zhang F. Washed microbiota transplantation alleviates tyrosine kinase inhibitors associated gastrointestinal adverse effects. Int J Cancer. 2025 Dec 1;157(11):2354-2362. doi: 10.1002/ijc.70034. Epub 2025 Jul 4. PMID 40613778