Allergic DiseasesEarly Phase 1NCT03567707
Vaginal Microbiome Exposure and Immune Responses in C-section Infants
A Early Phase 1 study testing Vaginal seeding and Post-seeding Care in people with Allergic Diseases and Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
The purpose of this research study is to assess at how differences in the microbiome (naturally occurring bacteria) of a baby may protect, or put a baby at risk, for allergic problems. The microbiome refers to the thousands of bacteria and molds that live in and on our bodies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Allergic Diseases, Asthma
- What is being tested?
- Vaginal seeding and Post-seeding Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Nov 2018to Jan 2027
- Phase
- Early Phase 1
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman must be able to understand and provide informed consent;
- Pregnant women with singleton pregnancies with a non-anomalous, appropriately-grown fetus; and
- Atopic disease (asthma, allergic rhinoconjunctivitis, or atopic dermatitis) or food allergy in a first-degree relative of the infant to-be-delivered (for exception, see exclusion criteria*).
Who cannot join
- For C-Section Mothers:
- In labor with evidence of cervical change prior to the scheduled C-section;
- Rupture of the amniotic sac; or
- Vaginal pH > 4.5 on the day of delivery.
- For Vaginal Delivery Mothers:
- Use of induction agents for cervical ripening (cervical prostaglandin or Foley catheter).
Show all 32Show fewer
- For All Mothers and Their Infants:
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
- History of moderate to severe atopic dermatitis within the past year in the mother;
- Express no intention to breastfeed;
- History of diabetes mellitus or gestational diabetes mellitus;
- History of inflammatory bowel disease (IBD) (e.g., Crohn's Disease or ulcerative colitis);
- Evidence of an active sexually transmitted infection (STI) (e.g., primary herpes or genital warts, or trichomonas), yeast infection, or vaginosis on the day of delivery;
- Evidence of prior or current hepatitis B or C infection as demonstrated by the presence of the hepatitis B surface antigen, antibody positivity against the hepatitis B core antigen, or antibody positivity against the hepatitis C virus;
- --Assessment for active hepatitis B and hepatitis C infection will be repeated for this study even if prior testing during the current pregnancy was negative;
- Evidence of Human Immunodeficiency Virus (HIV) infection (e.g., positive HIV serology or detectable viral load);
- Positive Group B Streptococcus (GBS) test results by rectovaginal swab performed within 5 weeks of delivery, a prior infant with invasive GBS disease, or GBS bacteriuria at any point during pregnancy;
- Evidence of N. gonorrhoeae or C. trachomatis infection by testing performed within 5 weeks of delivery;
- History of antibiotic administration during the third trimester of the current pregnancy;
- Mothers with serious chronic conditions during pregnancy;
- Mothers with complicated pregnancies including pre-eclampsia, chorioamnionitis, placenta previa, vasa previa, placental abruption, or active vaginal bleeding;
- Maternal fever on the day of delivery (visit 0);
- Infants with complications during delivery, such that the infant requires more than the standard neonatal resuscitation after delivery;
- Infants delivered prior to 37 weeks of gestation;
- Thick particulate meconium noted upon delivery of the infant;
- Presence of a congenital abnormality in the infant for which study participation is not recommended;
- Current, diagnosed mental illness or current, diagnosed or self-reported drug or alcohol abuse in the mother that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements;
- Use of investigational drugs during the third trimester of pregnancy; or
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator may:
- Pose additional risks from participation in the study,
- Interfere with the participant's ability to comply with study requirements, or
- May impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai West
New York, New York, 10019
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Exposure to Vaginal Microbiome in C-section Infants at High-risk for Allergies - A Pilot Study
The purpose of this research study is to assess at how differences in the microbiome (naturally occurring bacteria) of a baby may protect, or put a baby at risk, for allergic problems. The microbiome refers to the thousands of bacteria and molds that live in and on our bodies. The microbiome plays an important role in our health. Differences in the microbiome can affect our immune system in ways that might make some people more likely to get allergies and asthma.
Early life events and exposures are very important for establishing the human microbiome. The newborn baby's microbiome changes very quickly during the first weeks and months of life. There is information that suggests C-section birth is associated with higher risk of certain diseases, including allergies and asthma. Some researchers think one reason for this is that passing through the mother's vaginal canal during birth exposes the baby to bacteria that promote healthy immune system development, something that C-section babies don't get. Transferring these potentially beneficial vaginal bacteria to C-section babies may help prevent some diseases later.
Read the detailed description
This is a pilot study of 120 pregnant women and their infants conducted at hospitals in the Mount Sinai Health System in New York, NY. Eighty women will deliver via elective, unlabored C-section, and 40 will undergo spontaneous vaginal delivery. The 80 women undergoing C-section will be randomized in a masked (blinded) 1:1 fashion to have their neonates undergo vaginal seeding or placebo seeding immediately after birth (within 10 minutes) followed by standard care.The infants of the 40 women undergoing spontaneous vaginal delivery will receive usual standard care.
All 120 pregnant women will have biospecimens collected to assess their vaginal, skin, gut, placental, breast milk, and oral microbiome. All infants will have biospecimens collected to assess their gut, skin, nasal, and oral microbiome, as well as blood to assess allergen sensitization and immune markers. Infants will be followed with at-home stool collections and questionnaires weekly for the first 4 weeks and at weeks 8, 26, and 39. An in-person study visit will occur at 13 weeks and 52 weeks, and the primary endpoint will be assessed at 52 weeks. Study enrollment is projected to occur over 24 months.
- Conditions
- Allergic Diseases, Asthma
- Being tested
- Vaginal seeding, Placebo Seeding, Standard care, Post-seeding Care
- Keywords
- Vaginal seeding, Immune responses, Allergen sensitization
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal seedingDrug
Also called vaginal microbiota, maternal vaginal microbiota
Mother-infant pair randomized to vaginal microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the vaginal microbiota soaked gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.
Placebo SeedingDrug
Also called placebo microbiota, placebo vaginal microbiota
Mother-infant pair randomized to placebo microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the placebo gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.
Standard careOther
Also called standard of care
Mother-infant pair, with both receiving standard of care which includes standard physical exams, vital signs monitoring and medication administration given as standard care for the delivery
Post-seeding CareOther
Following the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery.
| Study group | Role | What they receive |
|---|---|---|
| C-section -Vaginal seeding | Experimental | Pregnant women who undergo C-section and (neonate) vaginal seeding.
Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with gauze containing their mother's vaginal microbiota just after delivery. Receives: Drug: Vaginal seeding; Other: Standard care; Other: Post-seeding Care |
| C-section - Placebo Seeding | Experimental | Pregnant women who undergo C-section and (neonate) placebo seeding.
Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with sterile gauze (placebo). Receives: Drug: Placebo Seeding; Other: Standard care; Other: Post-seeding Care |
| Vaginal Delivery | Active comparator | Pregnant women who undergo spontaneous vaginal delivery (of neonate). Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Sensitization to at Least One Food Allergen at 12 months of age - by Treatment Group
Evaluation for the presence of food allergens (egg, milk, and peanut) in infants at 12 months of age. Sensitization is defined by a serum IgE ≥ 0.1 kUA/mL for each allergen.
Measured: Infants at 12 months of age (=Month 12 visit)
Secondary outcomes (6)
Occurrence of Adverse Events (AEs) -by Treatment Group
Adverse events reported as possibly related, probably related, or definitely related to study participation.
Measured: From birth to 12 months of age (=Month 12 visit)
Presence of Sensitization to at Least One Aeroallergen at 12 months of age - by Treatment Group
Evaluation for the presence of aeroallergens (house dust mite (Dermatophagoides pteronyssinus), cat (Felis domesticus), and/or cockroach (Blattella germanica)), in infants at 12 months of age as determined by serum IgE assessment. Sensitization is defined by a serum IgE ≥ 0.1 kUA/mL for each allergen.
Measured: Infants at 12 months of age (=Month 12 visit)
Level of Allergen-Specific Atopy at 12 months of age - by Treatment Group
Defined by serum IgE levels. Sensitization is defined by a serum IgE ≥ 0.1 kUA/mL for each allergen. The following allergen-specific IgE levels will be included: egg, milk, peanut, house dust mite (Dermatophagoides pteronyssinus), cat (Felis domesticus) and cockroach (Blattella germanica).
Measured: Infants at 12 months of age (=Month 12 visit)
Level of Combined Allergen-Specific Atopy at 12 Months of Age - by Treatment Group
Defined as the sum of the serum IgE levels to: egg, milk, peanut, house dust mite (Dermatophagoides pteronyssinus), cat (Felis domesticus), and cockroach (Blattella germanica).
Necessary for inclusion in this outcome measure: Available results for all six allergen-specific IgE levels.
Measured: Infants at 12 months of age (=Month 12 visit)
Number of Food Allergens and Aeroallergens Each Infant is Sensitized to at 12 Months of Age-by Treatment Group
Defined by serum IgE levels. Sensitization is defined by a serum IgE ≥ 0.1 kUA/mL.
Measured: Infants at 12 months of age (=Month 12 visit)
Severity of Atopic Dermatitis - by Treatment Group
Severity will be measured using the Eczema Area and Severity Index (EASI), a standardized investigator-assessed instrument.
Measured: Infants at 3 months and 12 months of age (=Month 3 and -12 visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start28 Nov 2018
- Primary completion30 Jan 2025
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will enroll pregnant women during the third trimester of pregnancy whose infants have a first-degree relative ( the mother, biological father, or full sibling) with atopic disease or food allergy.The study excludes women with a history of active atopic dermatitis within the past 5 years to avoid the potential transfer of vaginal microbiota to the infant that may predispose to atopic disease.Women undergoing elective, unlabored C-section will be randomized to have their infants undergo vaginal seeding or placebo seeding plus standard of care. Women and infants who undergo placebo seeding will serve as a control population.In addition, women and infants undergoing vaginal delivery will also be included as a second control group, in part to determine if vaginal seeding will decrease allergen sensitization rates to a level similar to vaginally delivered infants, and also to serve as a comparator group for gut microbiome development during the infant's first year of life.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
- Responsible party
- Sponsor
- Investigators
- Hugh A. Sampson, MD, Study chair, Icahn School of Medicine at Mount SinaiJose C. Clemente, PhD, Study chair, Icahn Institute for Genomics & Multiscale Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567707
- Sponsor's protocol ID
- DAIT ITN079AD
- Other IDs
- ACTIVATE
- Status last verified
- Nov 2025
- First submitted
- 13 Jun 2018
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to share data upon completion of the study in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Vaginal Microbiome in C-section Infants at High-risk for Allergies - A Pilot Study
- ClinicalTrials.gov ID
- NCT03567707
- Acronym / sponsor ID
- DAIT ITN079AD
- Conditions
- Allergic Diseases, Asthma
- Keywords
- Vaginal seeding, Immune responses, Allergen sensitization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Jun 2018 (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 purpose of this research study is to assess at how differences in the microbiome (naturally occurring bacteria) of a baby may protect, or put a baby at risk, for allergic problems. The microbiome refers to the thousands of bacteria and molds that live in and on our bodies. The microbiome plays an important role in our health. Differences in the microbiome can affect our immune system in ways that might make some people more likely to get allergies and asthma.
Early life events and exposures are very important for establishing the human microbiome. The newborn baby's microbiome changes very quickly during the first weeks and months of life. There is information that suggests C-section birth is associated with higher risk of certain diseases, including allergies and asthma. Some researchers think one reason for this is that passing through the mother's vaginal canal during birth exposes the baby to bacteria that promote healthy immune system development, something that C-section babies don't get. Transferring these potentially beneficial vaginal bacteria to C-section babies may help prevent some diseases later.
Detailed description
This is a pilot study of 120 pregnant women and their infants conducted at hospitals in the Mount Sinai Health System in New York, NY. Eighty women will deliver via elective, unlabored C-section, and 40 will undergo spontaneous vaginal delivery. The 80 women undergoing C-section will be randomized in a masked (blinded) 1:1 fashion to have their neonates undergo vaginal seeding or placebo seeding immediately after birth (within 10 minutes) followed by standard care.The infants of the 40 women undergoing spontaneous vaginal delivery will receive usual standard care.
All 120 pregnant women will have biospecimens collected to assess their vaginal, skin, gut, placental, breast milk, and oral microbiome. All infants will have biospecimens collected to assess their gut, skin, nasal, and oral microbiome, as well as blood to assess allergen sensitization and immune markers. Infants will be followed with at-home stool collections and questionnaires weekly for the first 4 weeks and at weeks 8, 26, and 39. An in-person study visit will occur at 13 weeks and 52 weeks, and the primary endpoint will be assessed at 52 weeks. Study enrollment is projected to occur over 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- This study will enroll pregnant women during the third trimester of pregnancy whose infants have a first-degree relative ( the mother, biological father, or full sibling) with atopic disease or food allergy.The study excludes women with a history of active atopic dermatitis within the past 5 years to avoid the potential transfer of vaginal microbiota to the infant that may predispose to atopic disease.Women undergoing elective, unlabored C-section will be randomized to have their infants undergo vaginal seeding or placebo seeding plus standard of care. Women and infants who undergo placebo seeding will serve as a control population.In addition, women and infants undergoing vaginal delivery will also be included as a second control group, in part to determine if vaginal seeding will decrease allergen sensitization rates to a level similar to vaginally delivered infants, and also to serve as a comparator group for gut microbiome development during the infant's first year of life.
| Arm | Type | Receives |
|---|---|---|
| C-section -Vaginal seeding | Experimental | Drug: Vaginal seeding, Other: Standard care, Other: Post-seeding CarePregnant women who undergo C-section and (neonate) vaginal seeding. Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with gauze containing their mother's vaginal microbiota just after delivery. |
| C-section - Placebo Seeding | Experimental | Drug: Placebo Seeding, Other: Standard care, Other: Post-seeding CarePregnant women who undergo C-section and (neonate) placebo seeding. Infants that are scheduled to be born in a hospital by standard C-section procedure (e.g., elective, unlabored C-section) will be wiped with sterile gauze (placebo). |
| Vaginal Delivery | Active comparator | Other: Standard carePregnant women who undergo spontaneous vaginal delivery (of neonate). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant woman must be able to understand and provide informed consent;
- Pregnant women with singleton pregnancies with a non-anomalous, appropriately-grown fetus; and
- Atopic disease (asthma, allergic rhinoconjunctivitis, or atopic dermatitis) or food allergy in a first-degree relative of the infant to-be-delivered (for exception, see exclusion criteria*).
Key exclusion criteria (32 listed)
- In labor with evidence of cervical change prior to the scheduled C-section;
- Rupture of the amniotic sac; or
- Vaginal pH > 4.5 on the day of delivery.
- Use of induction agents for cervical ripening (cervical prostaglandin or Foley catheter).
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
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 |
|---|---|---|
| Vaginal seedingAlso: vaginal microbiota, maternal vaginal microbiotaMother-infant pair randomized to vaginal microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the vaginal microbiota soaked gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once. | Drug | C-section -Vaginal seeding |
| Placebo SeedingAlso: placebo microbiota, placebo vaginal microbiotaMother-infant pair randomized to placebo microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the placebo gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once. | Drug | C-section - Placebo Seeding |
| Standard careAlso: standard of careMother-infant pair, with both receiving standard of care which includes standard physical exams, vital signs monitoring and medication administration given as standard care for the delivery | Other | C-section - Placebo Seeding, C-section -Vaginal seeding, Vaginal Delivery |
| Post-seeding CareFollowing the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery. | Other | C-section - Placebo Seeding, C-section -Vaginal seeding |
Primary outcome
Presence of Sensitization to at Least One Food Allergen at 12 months of age - by Treatment Group
Time frame: Infants at 12 months of age (=Month 12 visit)
Evaluation for the presence of food allergens (egg, milk, and peanut) in infants at 12 months of age. Sensitization is defined by a serum IgE ≥ 0.1 kUA/mL for each allergen.
6 secondary outcomes
Occurrence of Adverse Events (AEs) -by Treatment Group
Time frame: From birth to 12 months of age (=Month 12 visit)
Presence of Sensitization to at Least One Aeroallergen at 12 months of age - by Treatment Group
Time frame: Infants at 12 months of age (=Month 12 visit)
Level of Allergen-Specific Atopy at 12 months of age - by Treatment Group
Time frame: Infants at 12 months of age (=Month 12 visit)
Level of Combined Allergen-Specific Atopy at 12 Months of Age - by Treatment Group
Time frame: Infants at 12 months of age (=Month 12 visit)
Number of Food Allergens and Aeroallergens Each Infant is Sensitized to at 12 Months of Age-by Treatment Group
Time frame: Infants at 12 months of age (=Month 12 visit)
Severity of Atopic Dermatitis - by Treatment Group
Time frame: Infants at 3 months and 12 months of age (=Month 3 and -12 visits)
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 5 Nov 2025.
- ITN website for trialLink provided by the sponsor.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Immune Tolerance Network (ITN)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The plan is to share data upon completion of the study in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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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. This study is not recruiting at the moment.
Hugh A. Sampson, MD study chair
Icahn School of Medicine at Mount Sinai
Jose C. Clemente, PhD study chair
Icahn Institute for Genomics & Multiscale Biology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vaginal seeding and Post-seeding Care in people with Allergic Diseases and Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
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 32 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Sensitization to at Least One Food Allergen at 12 months of age - by Treatment Group (time frame: Infants at 12 months of age (=Month 12 visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2025.