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Probiotic pill may stop recurrent strep throat in children

NCT ID NCT06370208

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 21, 2026 · Updated 9 times

Summary

This study tests whether a specially designed probiotic, Streptococcus salivarius eK12, can prevent repeated strep throat infections in children aged 3 to 10. The probiotic is given as a daily supplement and aims to crowd out the harmful bacteria without antibiotics. Researchers will track how many strep infections occur and check for side effects.

What this could mean

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

Active substance
Probiotic Streptococcus salivarius eK12 (Bactoblis® EVOL)
What this could lead to
If it works, this could offer a safe, non-antibiotic way to prevent frequent strep throat infections in children.
What could go wrong
This is a small, early-stage trial (82 children) testing a probiotic, not a drug. Results may not apply to all kids, and the effect may be modest.

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

82 people

The number who actually took part.

Started

Dec 2025

Finished

Jul 2026

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

3 to 11 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: * Children aged 3-11 years. * Recent history of documented recurrent episodes of Streptococcus pyogenes pharyngo- tonsillitis infection in the last 6 months, or 4 or more episodes in the last 12 months (S. pyogenes infection being defined as: McIsaac score with clinical score ≥ 2 plus confirmation of S. pyogenes presence with rapid throat swab (RAD) method or McIsaac score =5. * Willingness to comply with the study protocol and attend scheduled follow-up visits. * Written informed consent obtained from the parent or legal guardian. Exclusion Criteria: * Children with known allergies or hypersensitivity to probiotics or any components of the study product. * Current use of antibiotics or within the past 30 days. * Used oral colonizing probiotics in the last 6 months. * Presence of severe underlying medical conditions affecting the immune system or gastrointestinal tract. * Participation in other clinical trials involving investigational drugs or interventions. * Inability to adhere to the study requirements due to logistical or social reasons. * History of rheumatic disorders, bronchospasm, severe asthma, or allergy requiring corticosteroids. * Past tonsillectomy or an indication for adeno-tonsillectomy; or severe respiratory or systemic disorders * Individuals immunocompromised or had a condition favouring recurrent Acute Otitis Media (AOM), including severe atopy, acquired or congenital immunodeficiency, cleft palate, craniofacial abnormalities, obstructive adenoids, a chronically ruptured eardrum, sleep apnoea, or tympanostomy tubes * Children undergoing current pharmacological therapies to prevent recurrent respiratory infections. * Any other medical condition or circumstance that, in the investigator's judgment, would compromise the safety of the participant or the integrity of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CDF Hospital (Bilawal Medical College, LUMHS)

    Hyderābād, Sindh, 71000, Pakistan

  • Dr. Allah Wadhayo Kallo Clinic (Shifa Hurmat Diagnostic and Research Centre)

    Hyderābād, Sindh, 71500, Pakistan

  • Dr. Khan Afsar ENT Clinic

    Haripur, Khyber Pakhtunkhwa, 22620, Pakistan

  • Saboor Clinic

    Quetta, Balouchistan, 87300, Pakistan