Food AllergyNCT03667118
Introduction and Maintenance of Still Eating Protein Blends in Support of Infant Nutritional Goals
A study testing Food Supplement in people with Food Allergy, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of the study is to test a food supplement to: Show that the food supplement is well tolerated and safe to feed to infants; Find out how often parents/caregivers feed their infants the food supplement; Find out how parents/caregivers usually add the food supplement to infants' regular solid or liquid food… Read more about this study
- Who is it for?
- Ages 5 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- Food Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 705 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2017to 9 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infants, ≥ 5 months but < 11 months of age whose parent/caregiver can provide, in English, consent, understand instructions and complete a daily diet diary for their child, answer questions about how much and in what food they mix the Food supplement, and report any reaction or adverse event. Pregnant women will not be excluded if they have a child who is eligible for the study.
Who cannot join
- - Any parent/caregiver who cannot provide consent.
- Any parent/caregiver who cannot understand or write English.
- A parent/caregiver who is in prison.
- Any infant who
- Has a previous or current diagnosis of food allergy, made by a board-certified allergy and immunology specialist;
- Was born before 37 weeks of pregnancy (premature birth);
Show all 14Show fewer
- Has severe eczema, as determined by two parent/caregiver questions:
- During the past 6-11months, have you been told by a doctor or other health professional that your infant has eczema or any kind of skin allergy? (National Health Interview Survey, 2012) If yes, go to Question 2.
- Would you describe (his/her) eczema or skin allergy as mild, moderate, or severe? (National Survey of Children's Health, 2007) If described as severe, infant is excluded.
- Has a current serious, chronic condition, as measured by:
- Does you infant have a health condition that has lasted for more than three (3) months? If yes, go to Question 2.
- Has your infant been hospitalized more than 2 times since birth for this condition? If yes to Question 1 and 2, infant is excluded.
- If a parent/caregiver has multiple birth infants (e.g., twins), only one eligible infant will be selected.
- Any person who works for Before Brands or who has a family member working for Before Brands.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daily Ingestion of a Multi-Allergen Food Supplement by Infants: Clinical Symptoms, Reactions, and Acceptability - A Randomized Trial
The purpose of the study is to test a food supplement to:
- Show that the food supplement is well tolerated and safe to feed to infants;
- Find out how often parents/caregivers feed their infants the food supplement;
- Find out how parents/caregivers usually add the food supplement to infants' regular solid or liquid food; and
- Learn what aspects of the food supplement are more or less attractive to infants and to parents/caregivers.
Read the detailed description
The study involves parents/caregivers of infants, ≥ 5 months but < 11 months of age. Parents who enrolled their infants complete a 1-month blinded placebo run-in period, followed by randomization to placebo or the food supplement.
During the intervention period, infants randomized to the food supplement are fed a once daily, individual packet of the food supplement mixed into liquid (e.g., breast milk, infant formula) or solid (e.g., applesauce, pureed carrots) foods being fed to the infant. The food supplement is a blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat] [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon]) combined with 400 IU of Vitamin D3. Parents complete a daily diary about any reactions or symptoms within 2 hours of ingesting the food supplement. Infants randomized to the placebo are also fed a once daily individual packet of the placebo mixed into liquid or solid foods being fed to the infant. Parents also complete a daily diary about any reactions or symptoms within 2 hours of ingesting the placebo.
- Conditions
- Food Allergy
- Being tested
- Food Supplement
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food SupplementDietary supplement
A powder blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat] [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon]) combined with 400 IU of Vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| Food Supplement | Experimental | Infants who received the active food supplement powder Receives: Dietary Supplement: Food Supplement |
| Placebo | Placebo comparator | Infants who received the placebo powder Receives: Dietary Supplement: Food Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic-type reaction
difference between the proportion of infants with allergic-type reaction within 2 hours of ingestion in the food supplement versus placebo arm
Measured: 1month
Secondary outcomes (1)
Symptom
difference between the proportion of infants with a symptom within 2 hours of ingestion of the food supplement versus placebo arm
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start18 Jun 2017
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Holl, Northwestern University
- Investigators
- Jane L Holl, MD MPH, Principal investigator, Professor of Pediatrics, Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667118
- Sponsor's protocol ID
- STU00205862
- Status last verified
- Mar 2019
- First submitted
- 10 Sep 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Demographic data about the study participants Outcomes of the study
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Ingestion of a Multi-Allergen Food Supplement by Infants: Clinical Symptoms, Reactions, and Acceptability - A Randomized Trial
- ClinicalTrials.gov ID
- NCT03667118
- Acronym / sponsor ID
- STU00205862
- Conditions
- Food Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 18 Jun 2017 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 12 Sep 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 the study is to test a food supplement to:
- Show that the food supplement is well tolerated and safe to feed to infants;
- Find out how often parents/caregivers feed their infants the food supplement;
- Find out how parents/caregivers usually add the food supplement to infants' regular solid or liquid food; and
- Learn what aspects of the food supplement are more or less attractive to infants and to parents/caregivers.
Detailed description
The study involves parents/caregivers of infants, ≥ 5 months but < 11 months of age. Parents who enrolled their infants complete a 1-month blinded placebo run-in period, followed by randomization to placebo or the food supplement.
During the intervention period, infants randomized to the food supplement are fed a once daily, individual packet of the food supplement mixed into liquid (e.g., breast milk, infant formula) or solid (e.g., applesauce, pureed carrots) foods being fed to the infant. The food supplement is a blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat] [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon]) combined with 400 IU of Vitamin D3. Parents complete a daily diary about any reactions or symptoms within 2 hours of ingesting the food supplement. Infants randomized to the placebo are also fed a once daily individual packet of the placebo mixed into liquid or solid foods being fed to the infant. Parents also complete a daily diary about any reactions or symptoms within 2 hours of ingesting the placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Supplement | Experimental | Dietary Supplement: Food SupplementInfants who received the active food supplement powder |
| Placebo | Placebo comparator | Dietary Supplement: Food SupplementInfants who received the placebo powder |
Who may qualify
- Ages
- 5 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy infants, ≥ 5 months but < 11 months of age whose parent/caregiver can provide, in English, consent, understand instructions and complete a daily diet diary for their child, answer questions about how much and in what food they mix the Food supplement, and report any reaction or adverse event. Pregnant women will not be excluded if they have a child who is eligible for the study.
Key exclusion criteria (14 listed)
- - Any parent/caregiver who cannot provide consent.
- Any parent/caregiver who cannot understand or write English.
- A parent/caregiver who is in prison.
- Any infant who
- If a parent/caregiver has multiple birth infants (e.g., twins), only one eligible infant will be selected.
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 |
|---|---|---|
| Food SupplementA powder blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat] [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon]) combined with 400 IU of Vitamin D3 | Dietary supplement | Food Supplement, Placebo |
Primary outcome
Allergic-type reaction
Time frame: 1month
difference between the proportion of infants with allergic-type reaction within 2 hours of ingestion in the food supplement versus placebo arm
1 secondary outcome
Symptom
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No. Demographic data about the study participants Outcomes of the study
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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.
Jane L Holl, MD MPH principal investigator
Professor of Pediatrics, Feinberg School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Supplement in people with Food Allergy, run by Northwestern University at 1 site 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 1 inclusion and 14 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: finished, as of the sponsor's last update on 13 Mar 2019. 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 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Allergic-type reaction (time frame: 1month). 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 13 Mar 2019.