Importance and Association of Gut Microbiota and Biochemical Metabolites on Children Allergic Disorder

Completed

• Conditions: Allergic Disorder; Food Allergy in Children; Food Hypersensitivity
• Interventions: Other: Microbiota

• Registration Number: NCT05442658
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Food allergies account for only a small percentage of all adverse reactions to foods and their prevalence has increased over the past 10-15 years, particularly in industrialized countries: 3-6% of children under 3 years of age and 1-3% of adults. Food allergens in children are represented by milk, egg, wheat, soy, peanuts, tree nuts, fish, and shellfish. The majority of allergic processes that develop during the childhood tend to abate with age, whereas those that occur during adulthood tend to persist. Hypersensitivity refers to an excessive immunological reaction to food antigens with undesirable consequences.

The first aim of our study is to evaluate the role of intestinal microbiota and their relationship with immune tolerance or allergic disorder. The second aim of our study is determining the biochemical metabolites on the host (human being) in allergic disorder, and these biochemical metabolites can be measured in fecal or urine samples by metabolomics methods. We try to seek to gain an advanced understanding of gut microbiota and biochemical metabolites associated with mucosal immune responses in the host. These findings could be useful for developing strategies to modify the gut microbiota or medical applications (e.g. healthy microbe preparations) involving beneficial microorganisms to control the development of allergic disorders.

Detailed Description

Intestinal microbiota are directly involved in the development of innate and acquired mucosal immune response. The gut microbiota also have metabolic, synthetic, and processing functions in close liaison with the human body's metabolic processes. They are excellent energy anaerobic bioreactors, and they can consume, store, and redistribute the energy produced. The gut microbiota also allow us to extract energy from substances not otherwise useful in terms of energy, such as indigestible carbohydrates.

Intestinal microflora are able to use the substances consumed in the diet: bacteria can transform complex polysaccharides and monosaccharides in short-chain fatty acids. Short-chain fatty acids are a source of energy for colonocytes and directly affect the storage of lipids and the absorption and metabolism of food, creating the so-called 'second meal effect'.

Qualitative and quantitative alterations of commensal flora may result in various gastrointestinal and extraintestinal diseases. Food hypersensitivity and allergies are an emerging entity in the microbial related diseases universe.

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2022-06
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-30
• Last Update Submitted: 2022-06-30
• Study First Posted: 2022-07-05
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Children with immune tolerance; Children with food hypersensitivity Children with food allergy Children with allergic disorder Healthy volunteers (Children)

Exclusion Criteria

Exclusively vegetarian was not enrolled in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Food hypersensitivity, Food allergy	Microbiota	younger children undergo complete screening of the fecal microbiota and determination of total serum IgE and specific IgE levels. The specific IgE antibodies that were measured included those for the following food allergens: egg white, cow milk, wheat, peanut, soy, and gluten. Subjects with FH were defined as those with a total IgE level of over 100 IU/ml and a level of at least one specific IgE of greater than 0.35 IU/ml.
Healthy control	Microbiota	The control children came from an age-matched cohort and did not exhibit allergic manifestations or increased total or specific IgE levels.

Primary Outcome Measures

Name	Time	Method
microbiota	"baseline, pre-intervention"	Taxonomy-based analyses were performed by classifying each sequence using the RDP Naïve Bayesian rRNA Classifier Version 2.5 program
Biochemical Metabolites	"baseline, pre-intervention"	The identity of compounds will be confirmed by LC/MS/MS by using a QTOF (model 6510,Agilent). The water-soluble fraction of the fecal samples will be analyzed using 1H Nuclear magnetic resonance (NMR) spectroscopy.