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Gut bacteria may help pancreatic surgery recovery

NCT ID NCT07422103

Symptom relief Sponsor: Casa di Cura Dott. Pederzoli 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a probiotic called Clostridium butyricum CBM588 can reduce diarrhea and improve quality of life in people who have had their pancreas removed due to cancer or other growths. About 158 patients will take either the probiotic or a placebo for three months after surgery. The main goal is to see if it reduces daily bowel movements.

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 CBM588 (a probiotic)
What this could lead to
If it works, this probiotic could become a simple, safe way to ease diarrhea and improve gut health after pancreatic surgery.
What could go wrong
This is an early-stage trial with no phase designation, so results are uncertain. The probiotic may not improve symptoms more than a placebo.

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 158 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Nov 2030

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: * Age ≥ 18 years * Written informed consent * Patients undergoing pancreaticoduodenectomy * Candidates for upfront surgery without previous neoadjuvant chemotherapy or radiotherapy * Patients with benign or malignant periampullary neoplasms Exclusion Criteria: * Age \< 18 years * Previous or current use of Clostridium butyricum CBM588 * Lactose intolerance * Neoadjuvant chemotherapy or radiotherapy

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Conditions

The condition(s) this trial relates to.

Clostridium infectious disease malignant pancreatic neoplasm pancreas disorder pancreatic neoplasm periampullary adenocarcinoma

As listed by the trial registrant

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

CBM588 Clostridium butyricum miyairi Gastrointestinal symptoms Pancreatic cancer Pancreatic diseases Pancreatoduodenectomy

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

  • Ospedale Pederzoli

    Peschiera del Garda, Verona, 37019, Italy

More trials for these conditions

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