SHAPE Trial: Skin Health and Allergy Prevention Exposure (NCT07489040)
Multi-component Package for Skin Health and Allergen Exposure Strategy to Prevent Food Allergy
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to determine if a multi-component environmental package (MEP) can prevent food allergies among infants at risk of developing food allergies in early life. Researchers will compare the multi-component environmental package to regular care to see if the MEP works to prevent food allergies. Participants will: * Be assigned to the multi-component environmental package or regular care once their baby is born * Complete a weekly diary * Attend in-office visits at 4 and 12 months of age * Complete web-based questionnaires at 4, 6, 9 and 12 months of age
Who can join: Review the eligibility criteria below.
Location: McMaster University Medical Centre — Hamilton, Ontario
Age range: 37 Weeks to 42 Weeks
🧪 Interventions in This Study
- Multi-component environmental package (OTHER)
- standard of care (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- McMaster University Medical Centre — Hamilton, Ontario
📞 Contact the Study Coordinator
Phone: (905) 525-9140
Email: ahmedt57@mcmaster.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg — Rochester, New York
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.