NCT07533227

Intestinal Microbiota Transplantation for Treating Advanced Tumor Cachexia

Intestinal Microbiota Transplantation for Treating Advanced Tumor Cachexia: A Prospective, Multicenter, Single-arm, Phase II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Hua Jiang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study intends to include 66 patients with advanced gastric cancer, colorectal cancer, and lung cancer suffering from cachexia (including the pre-cachexia stage and the cachexia stage), who have received second-line or higher treatment. The patients will undergo a 12-week intervention of fecal microbiota transplantation. Fecal microbiota capsules will be orally administered at three time points: Day 0, Day 28, and Day 56. Blood and fecal samples will be collected at three time points: Day 0, Day 28, and Day 84 for metagenomic and metabolomic testing. Abdominal weight will be measured at four time points: Day 0, Day 28, Day 56, and Day 84. The above time points can be advanced or postponed by up to 3 days. The FAACT A/CS anorexia assessment scale and the Brief Fatigue Scale will be filled out. Liver function and CRP will be tested. The primary endpoint is the change in body weight compared to the baseline at 12 weeks (Day 84). The secondary endpoints include: the improvement in albumin, prealbumin, CRP, appetite, and fatigue compared to the baseline at 12 weeks, as well as safety.

Conditions

• Cachexia; Cancer
• Fecal Microbiota Transplantation (FMT)

Interventions

Type	Name	Description
DRUG	FMT capsule	Fecal microbiota capsules will be orally administered at three time points: Day 0, Day 28, and Day 56.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2026-04-16
• Last updated: 2026-04-16