Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04721041

Washed Microbiota Transplantation for the Treatment of Oncotherapy-Related Intestinal Complications

Led by The Second Hospital of Nanjing Medical University · Updated on 2025-03-06

200

Participants Needed

1

Research Sites

222 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Washed Microbiota Transplantation for the Treatment of Oncotherapy-Related Intestinal Complications

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with malignant tumor
  • Underwent cancer-related treatment and have gastrointestinal symptoms such as abdominal pain, diarrhea, abdominal distension, or difficulty defecating after standard tumor therapy (chemotherapy, radiation, immunotherapy, surgery, etc.)
  • Estimated survival time of 3 months or more with stable vital signs
  • Physically qualified and willing to undergo fecal microbiota transplantation
Not Eligible

You will not qualify if you...

  • Pregnant or nursing patients
  • Unable or unwilling to undergo gastroscopy or colonoscopy
  • Patients with cardiopulmonary failure
  • Use of antibiotics, proton pump inhibitors, probiotics, or other drugs affecting gut microbiota within the previous week
  • History of inflammatory bowel disease or intestinal symptoms unrelated to tumor treatment
  • Serious uncontrolled diseases or acute infectious diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210011

Actively Recruiting

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Research Team

F

Faming Zhang, MD,PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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