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SHAPE Trial: Skin Health and Allergy Prevention Exposure

NCT07489040 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-04-06

No results posted yet for this study

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

Conditions

  • Allergy and Immunology

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Derek Chu, MD, PhD, FRCPC · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
37 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-04-01
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07489040 on ClinicalTrials.gov