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

NCT04721041 | Recruiting DMC

• 1 other identifier: Cancer-CN-202010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Intestinal Complications; Cancer

Keywords

Fecal Microbiota Transplantation; Washed Microbiota Transplantation; Oncotherapy; Cancer; Intestinal dysbiosis

Outcome Measures

Primary Outcomes (2)

• Scores of gastrointestinal symptoms

  Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0

  8 weeks

• Stool frequency and consistency

  Stool frequency and consistency will be evaluated according to The Bristol Stool Form Scale (BSFS).

  8 weeks

Secondary Outcomes (2)

• Adverse events

  1 year

• Karnofsky Performance Status (KPS) scale

  8 weeks

Study Arms (2)

Washed Microbiota Transplantation (WMT)

EXPERIMENTAL

Patients undergo once WMT a day for three consecutive days.

Other: Washed Microbiota Transplantation (WMT)

Basic treatment

NO INTERVENTION

Basic treatment based on the lastest clinical guidelines

Interventions

Washed Microbiota Transplantation (WMT) OTHER

Washed microbiota suspension delivered through mid-gut and lower-gut

Also known as: fecal microbiota transplantation

Washed Microbiota Transplantation (WMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;

You may not qualify if:

• \. 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；

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (3)

• Prisciandaro 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 BACKGROUND

• Surawicz 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 BACKGROUND

• Zhang 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 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Faming Zhang, MD,PHD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: January 26, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)