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Intestinal Microbiota Transplantation for Treating Advanced Tumor Cachexia

ConditionsCachexia; CancerFecal Microbiota Transplantation (FMT)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHua Jiang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • FMT capsule

    Drug

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

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: FMTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Fasting weight

Time frame
Day 0, Day 28, Day 56, Day 84

Secondary outcomes

1

Albumin

Time frame
Day 0, Day 28, Day 56, Day 84
2

Prealbumin

Time frame
Day 0, Day 28, Day 56, Day 84
3

CRP

Time frame
Day 0, Day 28, Day 56, Day 84
4

Appetite

FAACT A/CS anorexia assessment scale

Time frame
Day 0, Day 28, Day 56, Day 84

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hua Jiang

Lead sponsor

Changzhou No.2 People's Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: