NCT07489040

SHAPE Trial: Skin Health and Allergy Prevention Exposure

Multi-component Package for Skin Health and Allergen Exposure Strategy to Prevent Food Allergy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 37 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Strategies that promote a healthy and diverse microbiome from early life, including careful management of hygiene practices, may be effective in preventing allergies. Excessive bathing, in frequency or intensity, using soaps and similar chemicals, may disrupt the skin barrier and developing microbiome, promoting aberrant immune responses directly or via promoting colonization by pro-allergic microbes. Strategies to reduce antimicrobial use, detergent/soap exposure, scheduled bathing frequency, skin allergen exposure, and promoting microbiome diversity may support immune tolerance and prevent the development of food allergy. Our systematic reviews show that no clinical trial currently addresses the effect of an environmental package for the prevention of food allergy. Thus, investigators propose SHAPE, the first trial evaluating the feasibility of a multicomponent environmental package (MEP) as an approach to prevent food allergy in early life. This randomized, assessor blinded, parallel, single center pilot trial will assess the feasibility in implementing MEP in preventing food allergy among infants. Birthing parents will be consented as early as 32 weeks gestational age up until delivery. After delivery, study staff will confirm eligibility and randomization will occur within 24 hours of birth among eligible neonates receiving either MEP (intervention) or standard of care (control) group in a 1:1 ratio. The Evidence in Allergy group at McMaster University will coordinate this pilot study. Clinicians at prenatal clinics or postpartum ward of McMaster University Medical Centre (MUMC) in Hamilton, Ontario, Canada will identify and invite pregnant women during third trimester to enroll their babies after birth in the study. Once the baby is born, study staff will screen and assess eligibility criteria for randomization. This trial will enroll healthy singleton, neonates born at term without complications. To be eligible, the newborn will have at least one of the following risk factors: is an only child (no live siblings); first-degree relatives (parents and/or siblings) with history of food allergy, allergic rhinitis/conjunctivitis, asthma, or atopic dermatitis. Once the signed consent form and eligibility are confirmed, study staff will randomize the participants to either the MEP (intervention group) or the standard of care (control group) within 24 hours of birth. Study staff will provide face-to-face instructions to the parents of the enrolled infant according to the assigned group. After enrollment, study staff will schedule follow-up calls and visits to collect data on adherence through web-based questionnaires at 4, 6, 9 and 12 months of age and in-office visits at 4 and 12 months. At the end of study, investigators will review feedback from the parents about the intervention, mode and timing of delivery, follow-up phone call intervals and method (texting, phone calls, e-mails, or combinations), structure of the web-based questionnaires, tools for recording adverse events (e.g., electronic diary cards) for further tailoring of these methods before scaling up to larger trial.

Conditions

• Allergy and Immunology

Interventions

Type	Name	Description
OTHER	Multi-component environmental package	Participants randomized to the intervention group (MEP) will be advised to follow the following 6 recommendations: 1. Delay first bath until target of 7 days after birth and use only water for the first bath (i.e. no soap or cleanser). 2. Bathe a target of once per week. 3. Avoid bubble baths, harsh soaps and detergents (e.g. surfactants- or lye-containing agents detailed below). 4. Avoid using antimicrobial (disinfectant) wipes (e.g. "wet wipes" such as Dr. Brown's, Parent's choice, Aleva Naturals, Munchkin Arm \& Hammer, Chicco cleaning wipes) for cleaning skin outside of the perineum/anus. 5. Avoid using dishwasher with detergents or rinse-aids for washing baby feeding devices, soothers, and toys (e.g. breast pump, nursing bottles, nipples, pacifiers, teething devices, or toys). 6. Avoid exposing the skin to food, e.g. eating over top of baby, or handling baby with food residue on hands (e.g. peanut butter), or kissing baby with food residue on lips or in mouth.
OTHER	standard of care	If assigned to the control group, the parents will be advised to continue their preferred routine practices.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2028-12-31
• First posted: 2026-03-23
• Last updated: 2026-04-06

Locations

1 site across 1 country: Canada