Research Center: Boston Children’s Hospital
Location: Boston Children’s Hospital, 300 Longwood Ave, Boston, MA 02115
Lead Researcher: Wanda Phipatanakul, MD, MS
IRB: This study has been reviewed and approved by the Local Institutional Review Board

Recurrent wheezing is exhausting—for kids and parents alike. Standard treatments don’t always prevent episodes from coming back.
Research shows the immune system plays a key role in wheezing. OM-85, an oral supplement used in many countries to support immune health, is being studied to see if it can help reduce wheezing episodes in children aged 6 months to 5 years.
If your child experiences recurrent wheezing, they may qualify. Participants receive study-related care at no cost and will be compensated.

• Participants may receive a new potential treatment at no cost.
• Participants will be compensated for participating in this study.Participants may experience improvements in symptoms related to wheezing.
• Participants will be contributing valuable information that may benefit children in the future.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Children aged between 6 and 72 months (5 years old) 
• Your child must have had either:
  • At least 2 wheezing episodes in the past year, including 1 severe episode (requiring oral steroids or a visit to the emergency room), or
  • 3+ episodes requiring an unscheduled doctor visit, or 
  • at least 1 severe wheezing episode or 2+ episodes requiring an unscheduled doctor visit, while on daily ICS/LTRA therapy

• Born prematurely (before 34 weeks of gestational age)
• Have any known neoplasia or malignancy
• Have undergone any major surgery in the past 3 months or have planned surgery in the coming months
• Are unable to participate in the study for 5 visits, including attending 5 in-person visits at Boston Children’s Hospital

The study team will explain the research in its entirety, but some details are:

• Screening & Medical Assessment: A study provider will review their medical history, current medications, and any recent health issues. A physical exam will be conducted, including vital signs, height, weight, and BMI calculation. Blood tests, nasal swabs, and stool samples will be collected to monitor biological changes.
• Training & Monitoring: You will receive instructions on using an e-Diary and recognizing wheezing symptoms. Your child may undergo a COVID-19 test if symptoms arise.
• Questionnaires & Data Collection: You will complete questionnaires on your child’s feeding, allergies, asthma, rhinitis, and eczema as required by the study provider. Stool samples must be collected before certain visits and submitted at designated study visits.

Boston Children’s Hospital
Boston Children’s Hospital is a leading pediatric training and research institution affiliated with Harvard Medical School. Located in the heart of the Harvard Longwood Medical and Academic Area in Boston, Massachusetts, it is a nationally ranked, freestanding acute care children’s hospital renowned for its commitment to advancing pediatric care and research.