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Probiotic VSL#3 may tweak bile acids in IBD patients

NCT ID NCT01765439

Disease control Sponsor: Charles University, Czech Republic 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether the probiotic VSL#3 can change how bile acids work in people with Crohn's disease or ulcerative colitis. About 79 participants will take two sachets of VSL#3 daily for six weeks. Researchers will measure bile acid levels in blood and stool to see if the probiotic helps manage the disease.

What this could mean

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

Active substance
VSL#3 probiotic (a mix of live bacteria)
What this could lead to
If it works, this could point toward a way to improve bile acid balance and reduce symptoms in people with inflammatory bowel disease.
What could go wrong
This is a small, early-stage study with no phase, so results may not lead to a proven treatment. The probiotic may not change bile acid levels as hoped.

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

79 people

The number who actually took part.

Start date

Feb 2014

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: Arm CD resected * confirmed diagnosis of Crohn´s disease (at least 6 months) * history of single resection of terminal ileum (at least 6 months before inclusion) * maximum length of resected ileum is 60 cm * no signs of disease activity (clinical, endoscopical, laboratory) * stable medication Arm UC unoperated * confirmed diagnosis of ulcerative colitis (at least 6 months) * no signs of disease activity (clinical, endoscopical, laboratory) * stable medication Arm UC IPAA * confirmed diagnosis of ulcerative colitis (at least 6 months) * proctocolectomy and IPAA (at least 3 months before inclusion) * no signs of disease activity (clinical, endoscopical, laboratory) * stable medication Arm Healthy volunteers * no signs of gastrointestinal disorder * initial laboratory examination within normal range (blood count, liver function tests, C-reactive protein, Fe, ferritin, fecal calprotectin) Exclusion Criteria: * use of bile acids * use of bile acids sequestrants * use of farnesoid X receptor agonists/antagonists * recent colonoscopy(less than 1 month before inclusion) * diabetes

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

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

Crohn disease Ulcerative colitis

Contacts and locations

Locations

  • Iscare I.V.F.

    Prague, 17004, Czechia

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