Cachexia; CancerPhase 2FMT-CACHNCT07533227
Intestinal Microbiota Transplantation for Treating Advanced Tumor Cachexia
A Phase 2 study testing FMT capsule in people with Cachexia; Cancer and Fecal Microbiota Transplantation (FMT), run by Hua Jiang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia; Cancer, Fecal Microbiota Transplantation (FMT)
- What is being tested?
- FMT capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intestinal Microbiota Transplantation for Treating Advanced Tumor Cachexia: A Prospective, Multicenter, Single-arm, Phase II Clinical Study
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.
Read the 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.
- Being tested
- FMT capsule
- Keywords
- cachexia, FMT, Fecal Microbiota Transplantation
- Medical subject headings
- Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT capsuleDrug
Fecal microbiota capsules will be orally administered at three time points: Day 0, Day 28, and Day 56.
| Study group | Role | What they receive |
|---|---|---|
| FMT | Experimental | Not described Receives: Drug: FMT capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting weight
Measured: Day 0, Day 28, Day 56, Day 84
Secondary outcomes (6)
Albumin
Measured: Day 0, Day 28, Day 56, Day 84
Prealbumin
Measured: Day 0, Day 28, Day 56, Day 84
CRP
Measured: Day 0, Day 28, Day 56, Day 84
Appetite
FAACT A/CS anorexia assessment scale
Measured: Day 0, Day 28, Day 56, Day 84
Fatigue
Brief Fatigue Scale
Measured: Day 0, Day 28, Day 56, Day 84
Safety (Adverse event)
Measured: Day 0, Day 28, Day 56, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia; CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Jiang, Changzhou No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533227
- Sponsor's protocol ID
- [2025]YLJSA119
- Acronym
- FMT-CACH
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota Transplantation for Treating Advanced Tumor Cachexia: A Prospective, Multicenter, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07533227
- Acronym / sponsor ID
- FMT-CACH / [2025]YLJSA119
- Keywords
- cachexia, FMT, Fecal Microbiota Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hua JiangUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT | Experimental | Drug: FMT capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMT capsuleFecal microbiota capsules will be orally administered at three time points: Day 0, Day 28, and Day 56. | Drug | FMT |
Primary outcome
Fasting weight
Time frame: Day 0, Day 28, Day 56, Day 84
6 secondary outcomes
Albumin
Time frame: Day 0, Day 28, Day 56, Day 84
Prealbumin
Time frame: Day 0, Day 28, Day 56, Day 84
CRP
Time frame: Day 0, Day 28, Day 56, Day 84
Appetite
Time frame: Day 0, Day 28, Day 56, Day 84
Fatigue
Time frame: Day 0, Day 28, Day 56, Day 84
Safety (Adverse event)
Time frame: Day 0, Day 28, Day 56, Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMT capsule in people with Cachexia; Cancer and Fecal Microbiota Transplantation (FMT), run by Hua Jiang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hua Jiang, Prof. (+86 18015852711, czeyjh@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting weight (time frame: Day 0, Day 28, Day 56, Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.