Allergy and ImmunologySHAPENCT07489040
SHAPE Trial: Skin Health and Allergy Prevention Exposure
A study testing Multi-component environmental package in people with Allergy and Immunology, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Allergy and Immunology
- What is being tested?
- Multi-component environmental package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Tasnuva Ahmed, MPH, 905-525-9140 ext. 21349, ahmedt57@mcmaster.ca
Mackenzie Haggstrom, BHSc, 905-525-9140 ext. 21334, haggstrm@mcmaster.ca
About this study
Official title: 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
Read the 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
- Being tested
- Multi-component environmental package, standard of care
- Keywords
- Allergy, Allergy prevention, Skin health, Food allergy
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component environmental packageOther
Participants randomized to the intervention group (MEP) will be advised to follow the following 6 recommendations:
- Delay first bath until target of 7 days after birth and use only water for the first bath (i.e. no soap or cleanser).
- Bathe a target of once per week.
- Avoid bubble baths, harsh soaps and detergents (e.g. surfactants- or lye-containing agents detailed below).
- 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.
- 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).
- 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.
standard of careOther
If assigned to the control group, the parents will be advised to continue their preferred routine practices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Web-based questionnaires at 4, 6, 9 and 12 months will track adherence.
Recruitment
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.
Measured: 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).
Measured: 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
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.
Measured: Until 12 months of age (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start15 Jun 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Allergy and ImmunologyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1), assessor-blinded, parallel group, pilot (feasibility) trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek Chu, MD, PhD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489040
- Sponsor's protocol ID
- 17785
- Acronym
- SHAPE
- Status last verified
- Oct 2026
- First submitted
- 17 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators currently have no established plans to share participant data and no consent to share data as per the consent form.
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.
PubMed 26534744Ierodiakonou 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.
PubMed 27654604Tuballa 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.
PubMed 38123975de 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.
PubMed 32396244Marrs 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.
PubMed 23578298Tsuge 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.
PubMed 34828780Drislane 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.
PubMed 31622670Bjorksten 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.
PubMed 11590374
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-component Package for Skin Health and Allergen Exposure Strategy to Prevent Food Allergy
- ClinicalTrials.gov ID
- NCT07489040
- Acronym / sponsor ID
- SHAPE / 17785
- Conditions
- Allergy and Immunology
- Keywords
- Allergy, Allergy prevention, Skin health, Food allergy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized (1:1), assessor-blinded, parallel group, pilot (feasibility) trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Multi-component environmental packageDescription 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. |
| Control Group | Other | Other: standard of careIf assigned to the control group, the parents will be advised to continue their preferred routine practices. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-component environmental packageParticipants 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 | Intervention Group |
| standard of careIf assigned to the control group, the parents will be advised to continue their preferred routine practices. | Other | Control Group |
Primary outcome
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).
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.
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).
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 26534744De 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.
- Background: PubMed 27654604Ierodiakonou 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.
- Background: PubMed 38123975Tuballa 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.
- Background: PubMed 32396244de 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.
- Background: PubMed 23578298Marrs 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.
- Background: PubMed 34828780Tsuge 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.
- Background: PubMed 31622670Drislane 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.
- Background: PubMed 11590374Bjorksten 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.
- Individual participant dataSharing planned: No. Investigators currently have no established plans to share participant data and no consent to share data as per the consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Derek Chu, MD, PhD, FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component environmental package in people with Allergy and Immunology, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tasnuva Ahmed, MPH (905-525-9140 ext. 21349, ahmedt57@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Web-based questionnaires at 4, 6, 9 and 12 months will track adherence.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07489040, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.