MICROBIOM T78.4 T78.1 K02.9
Conditions
Interventions
Group 1: Group A receives via kiss-feeding a sugar free, grind biscuit containing small and increasing amounts of the following food allergens: peanut, hazelnut, hen's egg and cow's milk in addition t
Sponsors
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Eligibility
Sex/Gender
All
Age
4 Months to 8 Months
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diversity of the intestinal microbiome in infants with risk for atopic diseases in Group A vs. Group B after introduction of solids. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed