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

NCT ID: NCT05442658

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Allergic Disorder Food Hypersensitivity Food Allergy in Children

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Food hypersensitivity, Food allergy

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.

Microbiota

Intervention Type OTHER

Healthy control

The control children came from an age-matched cohort and did not exhibit allergic manifestations or increased total or specific IgE levels.

Microbiota

Intervention Type OTHER

Interventions

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Microbiota

Intervention Type OTHER

Eligibility Criteria

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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.

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Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chien-Chang Chen, MD

Pediatrics, Chang Gung Children's Hospital, Chang Gung Memorial Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CMRPG4C0061_CORPG3F0071-3F0073

Identifier Type: -

Identifier Source: org_study_id

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