Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using washed microbiota transplantation to treat intestinal issues from cancer therapy

Official title: Efficacy and Safety of Washed Microbiota Transplantation for the Treatment of Oncotherapy-Related Intestinal Complications

Run by The Second Hospital of Nanjing Medical University · NCT04721041 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorThe Second Hospital of Nanjing Medical University
Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations1 site (Nanjing, Jiangsu)
StatusRecruiting
StartedJanuary 26, 2021
Main results expectedMay 2025
Study endsMay 2025
Registry record updatedMarch 6, 2025
Trial IDNCT04721041 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with a diagnosed malignant tumor who are experiencing gastrointestinal symptoms after cancer treatment.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.