Intestinal Microbiota Transplantation for Treating Advanced Tumor Cachexia

NCT07533227 | Not Yet Recruiting Phase 2

• 1 other identifier: [2025]YLJSA119
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project is a prospective, multicenter, single-arm, phase II clinical study aimed at evaluating the efficacy and safety of fecal microbiota transplantation (FMT) in treating advanced tumor cachexia.

Conditions

Cachexia; Cancer; Fecal Microbiota Transplantation (FMT)

Keywords

cachexia; FMT; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Fasting weight

  Day 0, Day 28, Day 56, Day 84

Secondary Outcomes (6)

• Albumin

  Day 0, Day 28, Day 56, Day 84

• Prealbumin

  Day 0, Day 28, Day 56, Day 84

• CRP

  Day 0, Day 28, Day 56, Day 84

• Appetite

  Day 0, Day 28, Day 56, Day 84

• Fatigue

  Day 0, Day 28, Day 56, Day 84

Study Arms (1)

FMT

EXPERIMENTAL

Drug: FMT capsule

Interventions

FMT capsule DRUG

Fecal microbiota capsules will be orally administered at three time points: Day 0, Day 28, and Day 56.

FMT

Eligibility Criteria

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

You may qualify if:

• Pre-advanced or advanced tumor cachexia stage.
• Age ≥ 18 years old, ECOG score 0-2, expected survival \> 3 months.
• Patients with gastric cancer, colorectal cancer, or lung cancer who have received second-line or higher treatment.
• No FMT treatment in the past six months.

You may not qualify if:

• Any condition that affects gastrointestinal absorption, such as difficulty in swallowing, malabsorption, or uncontrollable vomiting; undergoing tube feeding or parenteral nutrition.
• Neurotic anorexia, anorexia caused by mental illness, or difficulty in eating due to pain.
• Acquired immunodeficiency syndrome.
• Currently taking or planning to take other drugs that increase appetite or weight, such as adrenal corticosteroids (except for short-term use of dexamethasone during chemotherapy), androgens, progestogens, salidroside, olanzapine, and anamorin or other appetite stimulants.
• Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with difficult-to-control diabetes.
• Current imaging or clinical manifestations of gastrointestinal obstruction.
• Current uncontrolled coexisting diseases, including but not limited to decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or mental illnesses/societal conditions that may limit patient compliance with study requirements or affect the patient's ability to provide written informed consent.
• Within 12 months prior to the first administration, there was unstable angina pectoris, myocardial infarction, congestive heart failure (grade 2 or above according to the New York Heart Association functional classification), or vascular diseases (such as aneurysms with a risk of rupture), or other cardiac damages that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmias, myocardial ischemia); within 6 months prior to the first administration, there was esophageal-gastric varices, severe ulcers, gastrointestinal perforation and/or fistula history, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess or history of acute gastrointestinal bleeding.
• Within 4 weeks prior to the first administration, a serious infection occurred, including but not limited to conditions requiring hospitalization.

Sponsors & Collaborators

• Hua Jiang: lead

MeSH Terms

Conditions

Cachexia; Neoplasms

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Hua Jiang, Prof.

CONTACT

+86 18015852711; czeyjh@njmu.edu.cn

Qin, Dr.

CONTACT

+86 18351975061; 110329776@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of oncology department

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share