Food Allergy treatment with Butyrate (FAB)

Monocentric, randomised single-blind, placebo-controlled clinical study to assess whether a Multicentric, randomised clinical pilot-study to assess whether a diet rich in milk products could increase oral tolerance to the incriminated food protein in food allergy children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16288291

Enrollment

Registered

2021-02-22

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food allergy among children Not Applicable Childhood food allergy

Interventions

Children with food allergy confirmed by an oral food challenge will be randomly allocated to either: 1. Intervention group, where participants will receive cow’s milk products daily corresponding to a

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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 2. Immune parameter levels measured using blood samples (sIgE, T cells population) from baseline to between 28 and 42 days	—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026