Development of an allergen containing test-biscuit for special, traditional feeding of babies

Not Applicable

Recruiting

• Conditions: MICROBIOM; T78.4; T78.1; K02.9; Allergy, unspecified; Other adverse food reactions, not elsewhere classified; Dental caries, unspecified

• Registration Number: DRKS00027255
• Lead Sponsor: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Healthy, full-term born infants
2. Age 4 – 8 months at Screening
3. Positive family history for atopic diseases
4. Signed informed consent of parents
5. Parents/ caregivers have the mental and linguistic capability to follow the protocol requirements

Exclusion Criteria

1. Previous consumption of hen´s egg, cow´s milk (except infant formula), peanut or hazelnut
2. Wheat allergy
3. Any other condition (for example severe concurrent disease, infection, comorbidity, e.g. acute trauma, serious oncological disease, serious renal disease, relevant cardiovascular disease, autoimmune diseases) or reason that may interfere with the ability to participate in the study, cause undue risk, or complicate the interpretation of data, in the opinion of the investigator
4. Participation in another interventional trial
5. Mother/caregiver with food allergy against hen´s egg, cow´s milk, peanut, wheat or hazelnut
6. Mother/caregiver who is going to chew solids with (acute) oral infections according to physicians decision

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diversity of the intestinal microbiome in infants with risk for atopic diseases in Group A vs. Group B after introduction of solids. <br>

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include assessment of acceptance/ compliance of the feeding habit, assessment of food allergy and sensitization, assessment of safety and thriving, as well as the composition of the oral microbiome in association with the caries status of the infant after 6 - 8 month of feeding