Poop pills tested to calm chemo gut woes in cancer patients

NCT ID NCT07319364

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether fecal microbiota transplantation (FMT) – taking donor gut bacteria in capsules – can prevent or reduce gastrointestinal symptoms like nausea, vomiting, and diarrhea caused by chemotherapy or targeted therapy. It involves 90 adults with advanced (Stage IV) gastrointestinal cancers who are already on treatment. Researchers will track symptom changes after FMT given before cycles 4, 6, and 8 of their cancer therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fecal microbiota transplantation (FMT) capsules
What this could lead to
If it works, this could offer a way to reduce nausea, vomiting, and diarrhea caused by chemotherapy or targeted therapy in people with advanced gastrointestinal cancers.
What could go wrong
This is a small, early-phase (Phase 1) observational study, so results are preliminary. FMT may not work for everyone and carries risks like infection or digestive discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years, gender not restricted; 2. Estimated survival time ≥ 3 months; 3. Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.; 4. TNM staging of cancer in patients is Stage IV; 5. Having undergone PD-1 or PD-L1 testing; 6. Planned to receive the 4th cycle of chemotherapy/targeted therapy; 7. Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy/targeted therapy; 8. Patients are able and willing to sign the informed consent form and complete follow-up; 9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3; 10. Use of oral/intravenous broad-spectrum antibiotics with caution within 3 days; 11. Patients are able to swallow capsules without chewing; 12. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3; 13. Laboratory test results during the screening period indicate that the subjects have sufficient organ function. Exclusion Criteria: 1. 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; 2. Uncontrolled or severe infections; 3. Known history of psychotropic substance abuse, alcoholism, and drug abuse; 4. Patients with severe infections complicated with septicemia or sepsis; 5. Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules; 6. Patients with active viral infections; 7. Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks); 8. Patients with gastrointestinal perforation and/or fistula; 9. Other conditions deemed unsuitable for enrollment by the investigator.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Antineoplastic agents are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Zhejiang, Hangzhou, 310009, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.