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New probiotic bug passes first safety test in small human trial

NCT ID NCT07285317

Knowledge-focused Sponsor: Spanish National Research Council 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tested whether a new probiotic bacterium called Phascolarctobacterium faecium is safe and well-tolerated when taken daily as a pill for 15 days. Twenty adults—some with normal weight and some with overweight or early blood sugar issues—participated. Researchers monitored digestive symptoms, blood tests, and overall health to check for side effects. The study does not aim to treat any condition, only to see if the bacterium is safe enough for future research.

What this could mean

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

Active substance
Phascolarctobacterium faecium (a probiotic bacterium taken as a pill)
What this could lead to
If this bacterium is safe and well-tolerated, it could pave the way for larger studies exploring whether it helps improve metabolic health in people with obesity or type 2 diabetes.
What could go wrong
This is a very early, small Phase 1 trial with only 20 participants. It only tests safety and tolerability for 15 days, so it cannot show any health benefits. Mild digestive side effects like bloating or gas are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Feb 2024

Finished

Jan 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * 18-65 years * stable body weight and dietary habits during the previous three months * written informed consent Exclusion Criteria: * the presence of gastrointestinal disorders * immunodeficiency * eating disorders * antibiotic use within one month before the study * chronic antidiabetic therapy * substance (drug) abuse * restrictive diets * any other condition deemed inappropriate for participation by the clinician

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

Health Obesity / overweight Obesity type 2 diabetes mellitus

Contacts and locations

Locations

  • Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)

    Valencia, Spain

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