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New treatment option for Fecal Microbiota Transplantation (FMT)
Official title A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects
ClinicalTrials.gov ID: NCT07319364
What this study is testing
What is Fecal microbiota transplantation (FMT)?
Fecal microbiota transplantation (FMT) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for fecal microbiota transplantation (fmt).
Also referred to as Chemotherapy, Targeted Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years, gender not restricted;
- Estimated survival time ≥ 3 months;
- Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer...
- TNM staging of cancer in patients is Stage IV;
- Having undergone PD-1 or PD-L1 testing;
You likely can't join if
- Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or...
- Uncontrolled or severe infections;
- Known history of psychotropic substance abuse, alcoholism, and drug abuse;
- Patients with severe infections complicated with septicemia or sepsis;
- Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
- Patients with active viral infections;
See the full eligibility criteria
- Age ≥ 18 years, gender not restricted;
- Estimated survival time ≥ 3 months;
- Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;
- TNM staging of cancer in patients is Stage IV;
- Having undergone PD-1 or PD-L1 testing;
- Planned to receive the 4th cycle of chemotherapy/targeted therapy;
- Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy/targeted therapy;
- Patients are able and willing to sign the informed consent form and complete follow-up;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
- Use of oral/intravenous broad-spectrum antibiotics with caution within 3 days;
- Patients are able to swallow capsules without chewing;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
- Laboratory test results during the screening period indicate that the people have sufficient organ function.
- Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency/hepatic failure;
- Uncontrolled or severe infections;
- Known history of psychotropic substance abuse, alcoholism, and drug abuse;
- Patients with severe infections complicated with septicemia or sepsis;
- Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
- Patients with active viral infections;
- Female people with a positive pregnancy test, lactating female people, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);
- Patients with gastrointestinal perforation and/or fistula;
- Other conditions deemed unsuitable for enrollment by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zhejiang, Hangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhejiang, Hangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.