SHAPE Trial: Skin Health and Allergy Prevention Exposure

Official title

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

Overview

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.

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

Primary outcome measures

• Adherence [Time frame: Web-based questionnaires at 4, 6, 9 and 12 months will track adherence.]
• Recruitment [Time frame: 12- months from study initiation]
• Retention [Time frame: Web-based questionnaire at 4, 6, 9, and 12 month age follow-up]

Secondary outcome measures (1)

• 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)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Canada · 1 center

• McMaster University Medical Centre — Hamilton

Publications

• 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
• 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
• 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
• 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 trial PMID 32396244
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07489040 · 17785

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗