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Tiny study checks if novel bacterium is safe for people

NCT ID NCT07660107

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed trial tested whether a heat-killed bacterium called KGA-10 (also known as NeuroAlly) is safe and tolerable for healthy adults. Eight participants took either KGA-10 or a placebo daily for one week. Researchers tracked side effects and satisfaction using surveys. The study only looked at safety, not any health benefits.

What this could mean

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

Active substance
Heat-killed Mycolicibacterium petrae KGA-10 (a type of bacterium, also called NeuroAlly)
What this could lead to
If safe, this could pave the way for future studies exploring whether KGA-10 has any health benefits.
What could go wrong
This was a very small, early safety study with only 8 people. It does not test whether KGA-10 helps any condition, and larger studies are needed to confirm safety.

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

8 people

The number who actually took part.

Started

Jul 2025

Finished

Jul 2025

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: * Healthy individuals between the ages of 18 and 65 * Able to provide informed consent * Willing to take a daily supplement * Willing to complete at-home finger prick - blood spot samples on three occasions * English speaking Exclusion Criteria: * Inability to adequately respond to questions regarding the informed consent procedure * Currently involved in the criminal justice system as a prisoner or ward of the state * Non-English speaking * Current (past month) alcohol or substance abuse or dependence * Lifetime history of bipolar disorder or psychosis * Receiving intravenous, intramuscular, or oral antibiotics within the last month * Receiving medications that interfere with gut motility (opiates, loperamide, stool softeners) * Presence of central venous catheters (CVCs) * Gastrointestinal (GI) barriers as identified by the 2-week run-in period as determined by the study team (e.g., daily GI discomfort with frequent diarrhea prior to supplementation) * Participation in conflicting interventional research protocol * Vital signs outside of acceptable range (i.e., blood pressure \>160/100, oral temperature \>100°F, pulse \>100) * Use of any of the following drugs within the last 6 months: systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines or cytokine inhibitors; methotrexate or immunosuppressive cytotoxic agents * Acute disease at the time of enrollment (defer sampling until the participant recovers-acute disease is defined as the presence of a moderate or severe illness with or without fever) * Chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality * History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision * Positive test for human immunodeficiency virus (HIV), Hepatitis B virus, or Hepatitis C virus * Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection * Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time * Regular urinary incontinence necessitating use of incontinence protection garments * Female who is pregnant or lactating * Treatment for or suspicion of ever having had toxic shock syndrome * Those receiving immunosuppressive drugs or treatment including antineoplastic therapy, post-transplantation immunosuppressive therapy, and/or radiation therapy

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As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Colorado, Boulder - WILD campus

    Boulder, Colorado, 80301, United States

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