Food Allergy treatment with Butyrate (FAB)

Not Applicable

• Conditions: Food allergy among children; Not Applicable; Childhood food allergy

• Registration Number: ISRCTN16288291
• Lead Sponsor: Christine Kühne – Center for Allergy Research and Education (CK-CARE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-22
• Last Update Posted: 27 February 2023
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Aged 4-13 years
2. Food allergy (defined as a positive food challenge and positive sensitization to the same food allergen)
3. Staying at the rehabilitation clinic Hochgebirgsklinik (HGK), in Davos, for =6 weeks, seen by local pediatric physicians in Davos or Klosters, or recruited in the pediatric outpatient clinics of the University Children’s Hospital of Bern or the Children’s Hospital of Eastern Switzerland in St. Gallen

Exclusion Criteria

1. History of severe anaphylaxis defined by significant hypotension
2. Milk allergy (as the intervention will be based on a diet with dairy products)
3. Severe and uncontrolled asthma
4. Severe cardiac diseases
5. Treatment with beta-blockers
6. Pre-existing doctor diagnosis of immunodeficiencies
7. Children that already at the beginning of the study consume a high amount of cow’s milk products (corresponding to a butyrate level lower than 0.75 g for children aged 4-8, and lower than 1g for children aged 9-13)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Minimum amount of food protein needed to provoke an allergic reaction, defined as achieving an increase of 1 dose-level of the LOAEL (lowest observable adverse event level), measured using a standard oral food challenge (OFC) with the food allergen, at baseline and 5 weeks. The OFC will be done with the incriminated food, following a standard procedure with 7 dose-levels of food protein (3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 1000 mg, and 3000 mg) at an interval of at least 20 min.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Frequency of gastrointestinal side effects measured using the change of short-chain fatty acid (SCFA) level in fecal samples using ultra-high performance liquid chromatography (UHPLC) from baseline to 18 days, and 28 to 42 days<br> 2. Immune parameter levels measured using blood samples (sIgE, T cells population) from baseline to between 28 and 42 days<br>