Immune-supportive Diet and Gut Permeability in Allergic Children

NCT05667610 | Recruiting DMC

• 2 other identifiers: NL80586.100.22W21.302
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Peanut and nut allergy can be life threatening. Some patients have very low threshold levels (i.e. the amounts of peanut and nuts to which the patients react), others react to higher doses. The reasons for these differences in threshold are not well understood. Patients with peanut and nut allergy often suffer from other allergic diseases (atopic dermatitis, hay fever and asthma). A disturbed gut microbiota composition and an increased gut permeability may explain the development of allergic disease. We hypothesize that increased gut permeability is related to low threshold levels to peanuts or nuts. In addition, as it is known that nutrition can influence our gut permeability, we also hypothesize that a healthful immune-supportive diet restores gut permeability and alleviates symptoms. Therefore, the purpose of the study is to study in peanut and nut allergic children:

1. 1.the relationship between gut permeability and threshold levels to peanut or nuts;
2. 2.the effect of an immune-supportive diet on gut permeability, gut microbiome composition, coexisting allergic symptoms and quality of life

Conditions

Peanut Allergy; Nut Allergy

Keywords

Gut permeability; Immune-supportive diet; Thresholds

Outcome Measures

Primary Outcomes (1)

• Changes in small intestine permeability between baseline and after 4 months of dietary intervention as expressed by the Raffinose/Mannitol ratio in urine

  We will measure the ratio of Raffinose/Mannitol in urine at baseline and after 4 months of dietary intervention

  4 months

Secondary Outcomes (15)

• Relationship between gut permeability and the severity of atopic dermatitis

  At baseline

• Relationship between gut permeability and patient reported outcomes of asthma and allergic rhinitis

  At baseline

• Relationship between gut permeability and patient reported outcomes of gastrointestinal symptoms

  At baseline

• Relationship between gut permeability and treshold levels to peanut or nuts

  At baseline

• Differences in gut microbiota composition

  At baseline and after 4 months

Study Arms (2)

Intervention group (immune-supportive diet)

EXPERIMENTAL

* Immune-supportive diet (for 4 months) on top of peanut and/or nut free diet. Foods are allocated into 3 food groups: 1. Recommended in ample amounts: with an acknowledged beneficial role in immune health (first choice foods); 2. Recommended in limited amounts: with an acknowledged beneficial role in immune health when used in limited amounts (second choice foods). 3. Not recommended: with an acknowledged unfavourable role in immune health (third choice foods) * Self-assessed feasibility and adherence to the Immune-supportive diet (intervention group only) a by Likert scale after 2,5 and 4 months of dietary intervention; * Dietary adherence will be determined by the researchers after 4 months by calculating the number of first and second choice foods based on the food diaries after dietary intervention.

Other: Immune-supportive diet

Control group

ACTIVE COMPARATOR

\- Peanut and/or nut free diet only

Other: Standard care

Interventions

Immune-supportive diet OTHER

The intervention includes a immune-supportive diet over a period of 4 months

Intervention group (immune-supportive diet)

Standard care OTHER

Standard care: Peanut or nut free diet

Control group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who are potty trained or house trained;
• Presence of IgE to peanut ≥0.35 kilo units per liter (kU/l) or skin prick test \> 3 mm to peanut or nut, \< 12 months prior to challenge.

You may not qualify if:

• Only mild symptoms in the oral cavity to peanut or nut due to pollen food syndrome;
• A negative peanut or nut challenge;
• Children who are not potty trained (house trained);
• Gastro-intestinal diseases (e.g. Morbus Crohn, coeliac disease, Colitis Ulcerosa), lactose intolerance
• severe cow's milk allergy -because of possible traces of cow's milk in lactose in the SAT), syndromes, infectious/immunology diseases other than atopy, or diabetes;
• Laxative treatment, such as lactulose;
• Not able to read or write Dutch.

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead
• Ekhaga foundation: collaborator
• Rijnstate Hospital: collaborator
• Noordwest Ziekenhuisgroep: collaborator
• Erasmus Medical Center: collaborator
• Wageningen University: collaborator
• Amsterdam UMC: collaborator
• Utrecht Institute for Pharmaceutical Sciences: collaborator
• Diakonessenhuis, Utrecht: collaborator
• Deventer Ziekenhuis: collaborator
• Harvard University: collaborator

Study Sites (1)

OLVG

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Peanut Hypersensitivity; Nut Hypersensitivity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Berber Vlieg-Boerstra

CONTACT

+31620965612; b.vlieg-boerstra@olvg.nl

Chantal den Elzen, MSc

CONTACT

+31627538421; c.denelzen@olvg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The participants are randomly assigned to an intervention group or control group via castor.edc.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children in the intervention group will receive written and oral dietary advice by an allergy-specialist dietitian regarding their peanut or nut free diet according to standard care and, in addition, instructions on an individually tailored immune-supportive diet, including sample menus, recipes, shopping guide and product information. The dietitian will contact the patients every two to four-weeks as needed, either face-to-face, by video consult or using email or what app. Dietary compliance is orally checked by the dietitian, self-assessed dietary adherence and feasibility are score by Likert scale after 6 weeks and 3 months and dietary adherence is calculated by food diaries after 3 months. In addition, 22 healthy controls (without allergies),aged 4 to 12 years, will also be included.

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: December 28, 2022
• Study Start: September 8, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

NL (1)