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Gut bacteria cocktail tested as cancer treatment booster

NCT ID NCT03838601

Knowledge-focused Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a defined mixture of live gut bacteria from a healthy donor (MET-4) is safe and can be detected in patients with advanced oropharyngeal cancer receiving standard chemoradiation. Thirty participants took the bacteria by mouth daily for up to four weeks. The main goals were to check for side effects and to see if the bacterial strains could be found in stool samples. This is an early feasibility study, not designed to measure cancer outcomes.

What this could mean

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

Active substance
Microbial Ecosystem Therapeutics (MET-4) - a defined mixture of live gut bacteria from a healthy donor
What this could lead to
If successful, this could show that adding specific gut bacteria to standard cancer treatment is safe and may help understand how the microbiome affects treatment outcomes.
What could go wrong
This is a very small, early feasibility study with only 30 participants. It is designed mainly to check safety and whether the bacteria can be detected, not to prove any benefit against cancer.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Jul 2019

Finished

Sep 2025

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. Signed written and voluntary informed consent. 2. Patient must be willing and able to provide: -Oropharyngeal swab, stool and blood specimen at protocol specified time points. 3. Age \> 18 years, male or female. 4. Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oropharynx (soft palate, tonsils, base of tongue). 5. Patients must be eligible for curative-intent concurrent treatment with radiotherapy and chemotherapy. Exclusion Criteria: 1. Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result. 2. Subjects unable to swallow orally administered medications or any subjects with gastrointestinal disorders likely to interfere with absorption (e.g. bowel obstruction, short gut syndrome, blind loop syndrome, ileostomy etc). Subjects with colostomies may be enrolled. 3. Pregnant or planning to get pregnant in the next 6 months.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Head and neck squamous cell carcinoma

Contacts and locations

Locations

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

More trials for these conditions

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