SHAPE Pilot Trial: Skin Health and Allergy Prevention Exposure

NCT07489040 | Not Yet Recruiting DMC

• 1 other identifier: 17785
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Allergy; Allergy prevention; Skin health; Food allergy

Outcome Measures

Primary Outcomes (3)

• Adherence

  We 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

  We 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

• Retention

  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

Secondary Outcomes (1)

• Data collection on number of adverse events (AE) related to allergic reactions, skin and gastrointestinal conditions

  Until 12 months of age (end of study)

Other Outcomes (2)

• Diagnosed Food allergy

  12 (up to 18) months of age (end of study)

• Diagnosed Atopic dermatitis (AD)

  4-, 6-, 9-, and 12-months age follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

OTHER

If assigned to the control group, the parents will be advised to continue their preferred routine practices.

Other: standard of care

Interventions

Multi-component environmental package OTHER

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.

Intervention Group

standard of care OTHER

If assigned to the control group, the parents will be advised to continue their preferred routine practices.

Control Group

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• 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.
• Parent(s)/guardian provided informed consent for the child's study participation.

You may not qualify if:

• 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.
• 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.
• 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.
• No access to phone, internet, or email (requirements to contact participant/guardian).
• Planning to move out of the province within 12 months of study enrollment.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (8)

• De Marchi F, Piacentini GL, Piazza M, Sandri M, Boner AL, Peroni DG. Correlation of skin barrier impairment in atopic dermatitis with aeroallergen sensitization. Allergy Asthma Proc. 2015 Nov-Dec;36(6):e127-33. doi: 10.2500/aap.2015.36.3872.

  PMID: 26534744 BACKGROUND

• Ierodiakonou D, Garcia-Larsen V, Logan A, Groome A, Cunha S, Chivinge J, Robinson Z, Geoghegan N, Jarrold K, Reeves T, Tagiyeva-Milne N, Nurmatov U, Trivella M, Leonardi-Bee J, Boyle RJ. Timing of Allergenic Food Introduction to the Infant Diet and Risk of Allergic or Autoimmune Disease: A Systematic Review and Meta-analysis. JAMA. 2016 Sep 20;316(11):1181-1192. doi: 10.1001/jama.2016.12623.

  PMID: 27654604 BACKGROUND

• Tuballa A, Connell D, Smith M, Dowsett C, O'Neill H, Albarqouni L. Introduction of allergenic food to infants and allergic and autoimmune conditions: a systematic review and meta-analysis. BMJ Evid Based Med. 2024 Mar 21;29(2):104-113. doi: 10.1136/bmjebm-2023-112445.

  PMID: 38123975 BACKGROUND

• de Silva D, Halken S, Singh C, Muraro A, Angier E, Arasi S, Arshad H, Beyer K, Boyle R, du Toit G, Eigenmann P, Grimshaw K, Hoest A, Jones C, Khaleva E, Lack G, Szajewska H, Venter C, Verhasselt V, Roberts G; European Academy of Allergy, Clinical Immunology Food Allergy, Anaphylaxis Guidelines Group. Preventing food allergy in infancy and childhood: Systematic review of randomised controlled trials. Pediatr Allergy Immunol. 2020 Oct;31(7):813-826. doi: 10.1111/pai.13273. Epub 2020 Jun 18.

  PMID: 32396244 BACKGROUND

• Marrs T, Bruce KD, Logan K, Rivett DW, Perkin MR, Lack G, Flohr C. Is there an association between microbial exposure and food allergy? A systematic review. Pediatr Allergy Immunol. 2013 Jun;24(4):311-320.e8. doi: 10.1111/pai.12064. Epub 2013 Apr 11.

  PMID: 23578298 BACKGROUND

• Tsuge M, Ikeda M, Matsumoto N, Yorifuji T, Tsukahara H. Current Insights into Atopic March. Children (Basel). 2021 Nov 19;8(11):1067. doi: 10.3390/children8111067.

  PMID: 34828780 BACKGROUND

• Drislane C, Irvine AD. The role of filaggrin in atopic dermatitis and allergic disease. Ann Allergy Asthma Immunol. 2020 Jan;124(1):36-43. doi: 10.1016/j.anai.2019.10.008. Epub 2019 Oct 14.

  PMID: 31622670 BACKGROUND

• Bjorksten B, Sepp E, Julge K, Voor T, Mikelsaar M. Allergy development and the intestinal microflora during the first year of life. J Allergy Clin Immunol. 2001 Oct;108(4):516-20. doi: 10.1067/mai.2001.118130.

  PMID: 11590374 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity; Food Hypersensitivity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Derek Chu, MD, PhD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasnuva Ahmed, MPH

CONTACT

905-525-9140; ahmedt57@mcmaster.ca

Mackenzie Haggstrom, BHSc

CONTACT

905-525-9140; haggstrm@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinicians involved in the participants routine care will be blinded to which arm they are assigned to. To blind assessors, we will remind patients to not reveal information as to which group they are assigned. Blinded study staff (e.g. trial analyst, statistician, data manager) will remain blind to the allocated intervention until database lock.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized (1:1), assessor-blinded, parallel group, pilot (feasibility) trial

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)