SHAPE Trial: Skin Health and Allergy Prevention Exposure (SHAPE)

March 31, 2026 updated by: McMaster University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Derek Chu, MD, PhD, FRCPC
        • Sub-Investigator:
          • Rohan D'Souza, MD, PhD, FRCOG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Healthy singleton, neonates born at term (gestational age ≥37 weeks) (e.g. newborn without complications such as severe respiratory conditions, major congenital abnormalities, severe inborn errors of immunity [e.g. severe combined immunodeficiency], severe neonatal infections, neurologic impairment, and major gastrointestinal disorders).
  2. The newborn has any or 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.
  3. Parent(s)/guardian provided informed consent for the child's study participation.

Exclusion Criteria:

  1. Newborns born to mothers with positive routine prenatal screening for any of the vertically transmitted diseases (e.g. hepatitis B, hepatitis C, active syphilis or genital herpes simplex, Chlamydia trachomatis, gonorrhea and human immunodeficiency virus [HIV]) that may prevent adherence to any of the recommendations of the environmental packages.
  2. Inability to adhere to the study procedures, e.g. severe maternal conditions (e.g. eclampsia, life-threatening conditions requiring intensive care admission) or neonatal skin conditions that require specific care practices.
  3. Ongoing participation in another interventional study (e.g. trials involving skin care with topical creams, medication or interventions related to allergy prevention) that may interfere with the current study.
  4. No access to phone, internet, or email (requirements to contact participant/guardian).
  5. Planning to move out of the province within 12 months of study enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

Description of the recommendations included in the intervention package

  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: 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: Control Group
If assigned to the control group, the parents will be advised to continue their preferred routine practices.
Other: standard of care
If assigned to the control group, the parents will be advised to continue their preferred routine practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: Web-based questionnaire at 4, 6, 9, and 12 month age follow-up
Study staff will track the proportion of participants completing all scheduled follow-ups and providing complete data. Reasons for incomplete data will be recorded for both groups (e.g., admission to hospital due to any illness) from process-related reasons (i.e., insufficient reminders, too difficult to implement, other reasons specified by parents).
Web-based questionnaire at 4, 6, 9, and 12 month age follow-up
Adherence
Time Frame: Web-based questionnaires at 4, 6, 9 and 12 months will track adherence.
Investigators will measure the proportion of participants adhering to the protocol (MEP or control). Parents will log weekly details about bathing frequency, use of soap or detergents for bathing or using detergents for cleaning baby essentials and environmental exposure of food allergen to skin in weekly electronic diary card using REDCap. Reasons for non-adherence will be recorded for both groups. Successful adherence is anticipated if at least 50% of the participants completes the adherence form at the four study (4, 6, 9 and 12 months of age) time points and completes weekly diary card (at least 38 out of 52 weeks of follow-up).
Web-based questionnaires at 4, 6, 9 and 12 months will track adherence.
Recruitment
Time Frame: 12- months from study initiation
Investigators will determine the number of participants randomized to study groups (Group 1 or 2) over one year from the date of first accrual. A screening log will track eligible newborns and be used to assess the recruitment rate every week.
12- months from study initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data collection on number of adverse events (AE) related to allergic reactions, skin and gastrointestinal conditions
Time Frame: Until 12 months of age (end of study)
Parents will record symptoms related to food allergy reactions, skin and gastrointestinal conditions such as redness, itching, blistering, or crusting of skin, diarrhea, and vomiting on weekly diary and survey questionnaire during the scheduled follow-up. the study period until 12 months of age. Study staff will track the number and severity of these symptoms through parental reporting, clinical exam, and routine medical records until 12 months of age.
Until 12 months of age (end of study)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosed Atopic dermatitis (AD)
Time Frame: 4-, 6-, 9-, and 12-months age follow-up
Diagnosed cases of AD based on UK Working Party Diagnostic Criteria (UKWP) anytime confirmed at two separate time points, at least 1 month apart, between birth and 12 months of age. Blinded clinicians will assess AD. Parents of the infant will report severity of AD using Patient-Oriented Eczema Measure (POEM) while parents, clinicians and study staff will report severity using Scoring atopic dermatitis (SCORAD).
4-, 6-, 9-, and 12-months age follow-up
Diagnosed Food allergy
Time Frame: 12 (up to 18) months of age (end of study)
The proportion of diagnosed food allergy confirmed by clinical evaluation, by 12 (up to 18) months of age. The study will have a wide window of up to 18 months of age to accommodate multiple oral food challenge (OFCs) for individual infants as per routine clinical care.
12 (up to 18) months of age (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Derek Chu, MD, PhD, FRCPC, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigators currently have no established plans to share participant data and no consent to share data as per the consent form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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