Food Allergy treatment with Butyrate (FAB)
| ISRCTN | ISRCTN16288291 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16288291 |
- Submission date
- 11/01/2021
- Registration date
- 22/02/2021
- Last edited
- 25/10/2024
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Other
Plain English Summary
Background and study aims
The prevalence of allergic diseases and asthma are increasing worldwide; they doubled in the last 20 years. Food allergy has recently started to increase too. In westernized countries, around 1 in 20 children is allergic to at least one food. Food allergy can cause life-threatening anaphylactic reactions. Moreover, several studies have shown that food allergy has a strong negative impact on the quality of life.
Nutrition is a crucial environmental factor in early life, influencing the development of the child’s microbiota and immune system. It has been shown that consumption of cow's milk products, such as yogurt and butter, might have preventive effects on the development of allergic diseases, such as food allergy. Yogurt and other milk products constitute favorable growth conditions for the gut microbiota. Furthermore, they contain high levels of the immunomodulatory molecules short-chain fatty acids (SCFAs), which are associated with protection against allergic diseases in children.
With the rising prevalence of food allergy, a potentially life-threatening disease, and its major impact on the quality of life, treatments for food allergy are needed.
The study aims to increase tolerance to food proteins using a strategy based on the consumption of a diet rich in butyrate. Butyrate is a dietary component commonly found in cow’s milk fat, such as cheese and butter. Increasing the threshold dose of butyrate could help to further develop protocols of food oral immunotherapy for patients (children) with food allergies.
Who can participate?
Children aged between 4 and 13 with food allergies. Recruitment will be from the Children’s Hospital of Eastern Switzerland in St. Gallen, University Children’s Hospital of Bern, and Hochgebirgsklinik (HGK) Davos.
What does the study involve?
The participants in the study will be randomly divided into two groups. One group will follow a diet with the addition of cow’s milk products into their normal diet. Only milk products that are available in Switzerland will be included in the diet. The amount of cow’s milk products introduced is related to a certain amount of butyrate, that the milk products contain. These additional cow’s milk products will be included in the diet of children for 5 weeks. This will be compared to the second group of children continuing their normal diet.
What are the possible benefits and risks of participating?
The participants have no clear direct benefits as a result of participating in the study. However, the results of the study might support the development of diet patterns that might reduce the symptoms of food allergic children.
Adverse events (AE) related to the study-specific diet will be reported in a daily diary by the participants during the study.
Where is the study run from?
The Children’s Hospital of Eastern Switzerland in St. Gallen (Switzerland)
When is the study starting and how long is it expected to run for?
From March 2020 to April 2024
Who is funding the study?
The Kühne Foundation (Switzerland) and the Ulrich Müller Allergy Foundation (Switzerland)
Who is the main contact?
Ms Caroline Roduit, caroline.roduit@kispi.uzh.ch
Contact information
Scientific
Children’s Hospital of Eastern Switzerland in St. Gallen
Claudiusstrasse 6
St. Gallen
9000
Switzerland
 ORCID ID |
0000-0002-5988-0570 |
|---|---|
| Phone | +41712431997 |
| caroline.roduit@kispisg.ch |
Study information
| Study design | Monocentric single-blind randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | 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 |
| Study acronym | FAB |
| Study hypothesis | A diet rich in butyrate will help to improve the oral tolerance to the incriminated food protein among children with food allergies. |
| Ethics approval(s) | Approved 23/12/2020, Ethikkommission Ostschweiz (Scheibenackerstrasse 4, 9000 St.Gallen, Switzerland; +41 58 411 2891; sekretariat@ekos.ch), ref: 2020-02045 |
| Condition | Food allergy among children |
| Intervention | 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 minimal daily total butyrate intake of 1.5 g for children aged 4 to 8 years, and 2 g for children aged 9 to 13 years 2. Control group, where participants will continue a normal diet low in cow’s milk products (corresponding to a daily butyrate level lower than 0.75 g for children aged 4 to 8 years, and lower than 1 g for children aged 9 to 13 years) An electronic list of dairy products high in butyrate will be provided by a dietician. CHildren will follow the diet for 5 weeks. The randomization will be done with a 1:1 ratio. The allocation will be stratified for the study sites and the two age/dosage groups (4 to <9 years, and 9 to 13 years), such that the two treatment arms are balanced with respect to the age/dosage groups. The trial statistician is responsible to create a corresponding randomization list and is responsible that the randomization list is available in concealed from, i.e. in sealed envelopes for each individual patient, to the study team at each site. |
| Intervention type | Supplement |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 01/03/2020 |
| Overall study end date | 30/04/2024 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant 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 |
| Participant 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) |
| Recruitment start date | 01/03/2021 |
| Recruitment end date | 28/02/2024 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Davos
7265
Switzerland
Sponsor information
Research organisation
Herman-Burchard-Str. 1
Davos Wolfgang
7265
Switzerland
| Phone | +41 81 410 13 00 |
|---|---|
| info@ck-care.ch | |
| Website | https://www.ck-care.ch/ |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CK-CARE
- Location
- Switzerland
Results and Publications
| Intention to publish date | 30/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Caroline.Roduit@kispi.uzh.ch. All of the individual participant data collected during the trial, after identification will be available immediately following peer-reviewed publication with no end date. There will be no access criteria data and data will be shared with anyone who wishes to access the data. Other available documents include the Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code, and ethical or legal restrictions. |
Editorial Notes
25/10/2024: The study was terminated due to difficulties in recruitment.
15/02/2023: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 30/04/2023 to 30/04/2024 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 30/04/2024 to 30/04/2025.
3. The recruitment end date has been changed from 28/02/2023 to 28/02/2024.
18/02/2021: Trial’s existence confirmed by Ethikkommission Ostschweiz.
