Monthly capsule may keep wheezing away in babies at risk
NCT ID NCT02148796
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a monthly oral bacterial extract (Broncho-Vaxom) could prevent wheezing lower respiratory tract infections in infants aged 6-18 months who are at high risk for asthma. Over 800 participants received either the extract or a placebo for 10 days each month over two years. The goal was to see if the treatment could delay the first wheezing episode during a three-year follow-up period.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Broncho-Vaxom (bacterial extract)
- What this could lead to
- If it works, this could lead to a simple monthly treatment to prevent wheezing and asthma in high-risk infants.
- What could go wrong
- This is a Phase 2 trial, so results are still early. The treatment may not prove effective in larger or longer studies, and side effects 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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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822 people
The number who actually took part.
- Started
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Jan 2017
- Finished
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Jan 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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6 to 18 months
- 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: * Adequate completion of informed consent process with written documentation. The participant's legally acceptable representative must have provided the appropriate written informed consent. Assent forms will not be used due to the age of the participant population; however, for procedures later in the study when participants are older, age appropriate assent will be obtained, if required by local Institutional Review Board (IRB). * Age: 6-18 months of age inclusive at randomization which means 5 to 17 months of age inclusive on entry into the one month run-in period. At least half of all enrolled children will be between 6 and 12 months of age at randomization. * Participants will meet at least one of the following criteria, which have been associated with an increased risk of wheezing respiratory illnesses and asthma: a) Parental history of asthma -or- b) Physician-diagnosed atopic dermatitis in the participant - or- c) Physician-diagnosed asthma in a blood sibling aged 4 years or more. * Participants may be either male or female. * Participants will have at least one parent/guardian who can communicate with the study staff to allow assessment of study outcomes. All study materials used by parent/guardian will be made available in English and in Spanish. The child's parent/guardian must have a working direct contact telephone. Exclusion Criteria: * Participants may not have had more than two prior WLRI episodes. * Participants may not have had any SWLRI episodes. * Participants may not have a physician's diagnosis of asthma. * Participants may not have a systemic illness (other than allergy) including (but not limited to) recurrent seizures, chronic gastroesophageal reflux (GER) requiring medical treatment, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis or other chronic infections, primary or secondary immunodeficiency, gastrointestinal malformation or disease or cardiac disorder (except a hemodynamically insignificant atrial septal defect (ASD), ventricular septal defect (VSD) or benign heart murmur). * Participants may not have been born earlier than 36 weeks of gestation. * Participants may not have received oxygen for more than 5 days in the neonatal period, or received mechanical ventilation with the exclusion of ventilation during anesthesia for a minor surgical procedure. * Participants may not have significant neurodevelopmental delay. * Participants may not be below the 3rd percentile for weight. * Participants may not have any other chronic lung disease; e.g. chronic lung disease of prematurity (CLDP) or cystic fibrosis. * Participants may not have a history of any life-threatening respiratory illness that required intubation and mechanical ventilation. * The participant's family may not be expected to relocate out of study area within 3 years of the initiation of the study. * Participants may not have received inhaled or systemic corticosteroids for respiratory related illness ever, or for other conditions in the month prior to randomization. * Participants may not have ever received immunotherapy. * Participants may not have ever received i.v. gammaglobulins or systemic immunosuppressants. * Participants may not have received probiotics (Lactobacilli and Bifidobacteria) in medicinal form; (i.e. not including food), regularly for more than 4 months in the 6 to \<12 mo age group or 6 months in the 12 to 18 month group prior to enrollment. * Participant has known sensitivity to any of the study products and any of the ingredients to be administered. * Participant has previously been randomized in this study. Participants who failed run-in and were not randomized may have study participation terminated and then be re-enrolled for a second run-in period. * Participant is currently enrolled in or has completed any other investigational device or drug study \<30 days prior to screening, or is receiving other investigational agent(s). * Participant has a significant medical condition(s), anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the participant, or may interfere with study assessments, outcomes, or the ability to provide written informed consent or comply with study procedures, in the Investigator's opinion. * The one month run-in period will be used to evaluate adherence to study drug administration and electronic communication. At randomization the participant must continue to meet enrollment criteria and also have demonstrated 80% adherence to the placebo during treatment period; i.e. 8 out of 10 days and a75% response rate to weekly mobile phone text queries; i.e. 3 out of 4 weekly text queries. * Ongoing infection (of any organ system) at the time of randomization. This includes infections that are being adequately treated. * Unable or unlikely to complete study assessments or the study intervention poses undue risk to patient in the opinion of the Investigator. * Families will speak English and/or Spanish.
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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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Boston Children's Hospital, Harvard University
Boston, Massachusetts, 02115, United States
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Children's National Health System
Washington D.C., District of Columbia, 20037, United States
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Cincinnati Children's Hospital & Medical Center
Cincinnati, Ohio, 45229, United States
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Columbia University
New York, New York, 10032, United States
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Emory University
Atlanta, Georgia, 30322, United States
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Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
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University of Arizona
Tucson, Arizona, 85724, United States
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University of California San Francisco, Benioff Children's Hospital
Oakland, California, 94609, United States
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University of North Carolina
Chapel Hill, North Carolina, 27514, United States
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University of Wisconsin
Madison, Wisconsin, 53792-4108, United States
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Washington University
St Louis, Missouri, 63110, United States
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