Probiotic pill may stop recurrent strep throat in children
NCT ID NCT06370208
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
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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
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82 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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Jul 2026
- Lead sponsor
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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
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3 to 11 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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CDF Hospital (Bilawal Medical College, LUMHS)
Hyderābād, Sindh, 71000, Pakistan
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Dr. Allah Wadhayo Kallo Clinic (Shifa Hurmat Diagnostic and Research Centre)
Hyderābād, Sindh, 71500, Pakistan
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Dr. Khan Afsar ENT Clinic
Haripur, Khyber Pakhtunkhwa, 22620, Pakistan
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Saboor Clinic
Quetta, Balouchistan, 87300, Pakistan