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Can probiotic spores tame Crohn's and colitis Flare-Ups?

NCT ID NCT07799428

Disease control Sponsor: Anabio R&D 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether adding Bacillus probiotic spores to standard treatment can help people with Crohn's disease or ulcerative colitis. Researchers will give 150 adults either a placebo or one of two probiotic formulas for 30 days, alongside their usual care. The goal is to see if the probiotics improve gut symptoms, reduce disease activity, and boost quality of life. The study compares changes in symptom scores and well-being over the treatment period.

What this could mean

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

Active substance
Multi-strain Bacillus spore probiotics (LiveSpo COLON and LiveSpo DIA30) taken orally alongside standard IBD treatment
What this could lead to
If it works, adding Bacillus probiotic spores to standard IBD treatment could ease symptoms, improve quality of life, and reduce reliance on intensive therapies.
What could go wrong
This is an early-stage trial with a modest size, and the probiotic may not outperform placebo. Some people may experience digestive discomfort or other side effects.

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

About 150 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age 18 to 65 years. * Confirmed diagnosis of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, according to the routine diagnostic procedures of Hanoi Medical University Hospital. * Receiving examination and treatment at Hanoi Medical University Hospital (including both inpatients and outpatients), with a minimum treatment or follow-up duration of 14 days * Willing and able to provide written informed consent. Exclusion Criteria: * Refusal to participate in the study. * Withdrawal from the study before completing 14 days of treatment. * Inability to comply with study procedures or inability to ensure adherence to the investigational product, as assessed by the investigator. * Moderate to severe hepatic or renal dysfunction, or other moderate to severe chronic cardiovascular, pulmonary, hepatic, or renal diseases that may affect general health status or require specialist treatment. * Presence of immune-related diseases. * Current use, or use within 4 weeks prior to screening, of biologic immunosuppressive therapies (for example, anti-TNF-α agents or vedolizumab).

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Crohn disease and ulcerative colitis

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

  • Department of Gastroenterology

    Hà Nội, Vietnam

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