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Could a probiotic tame Chemo's worst side effects?

NCT ID NCT07152886

Symptom relief Sponsor: The Affiliated Hospital of Qingdao University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a probiotic called Clostridium butyricum can reduce severe diarrhea and other side effects in people getting chemotherapy for colorectal cancer. About 238 adults who had surgery for colorectal cancer and need chemo will take either the probiotic or a placebo. The main goal is to see if the probiotic lowers the chance of severe diarrhea.

What this could mean

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

Active substance
Clostridium butyricum capsules (a probiotic)
What this could lead to
If it works, this could offer a simple probiotic to ease severe diarrhea and other side effects during chemotherapy for colorectal cancer.
What could go wrong
This is a phase 4 trial, but it hasn't started yet. The probiotic may not reduce side effects more than a placebo, and results may not apply to all chemo regimens.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 238 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 to 70 years

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: * Aged 18-70 years; * No restriction on gender; * Have completed radical resection for colorectal cancer (including open, laparoscopic, or robotic surgery), and assessed by the MDT as requiring adjuvant therapy primarily based on 5-FU and its derivatives or platinum-based regimens (including chemotherapy, targeted therapy, or radiotherapy); * ECOG performance status score of 0-2; * Signed informed consent Exclusion Criteria: * Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment; * Presence of psychiatric disorders or other conditions that prevent cooperation with the intervention; * Dysfunction of vital organs such as the liver, kidneys, or heart that renders the individual unsuitable for clinical research upon assessment, or inadequate bone marrow, liver, or renal function to undergo adjuvant therapy; * Participation in other clinical studies within 3 months prior to enrollment; * History of inflammatory bowel disease; * History of autoimmune diseases; * Pregnancy or breastfeeding; * Receipt of neoadjuvant therapy (including chemotherapy, radiotherapy, or targeted therapy) prior to surgery; * Underwent ostomy surgery during the operation (including temporary or permanent ostomy).

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced toxicity colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Chemotherapeutic toxicity Colorectal cancer

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 Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266071, China

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