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

NCT05442658 | Completed

• 1 other identifier: CMRPG4C0061_CORPG3F0071-3F0073
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Disorder; Food Hypersensitivity; Food Allergy in Children

Keywords

Food sensitization; Food hypersensitivity; Food allergy

Outcome Measures

Primary Outcomes (2)

• microbiota

  Taxonomy-based analyses were performed by classifying each sequence using the RDP Naïve Bayesian rRNA Classifier Version 2.5 program

  "baseline, pre-intervention"

• Biochemical Metabolites

  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.

  "baseline, pre-intervention"

Study Arms (2)

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.

Other: Microbiota

Healthy control

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

Other: Microbiota

Interventions

Microbiota OTHER

Food hypersensitivity, Food allergy; Healthy control

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Younger children to undergo complete screening of the fecal microbiota and determination of total serum IgE and specific IgE levels. Fecal samples were immediately frozen at -20 °C after collection and were later stored at -70 °C. Before the enrollment of participants, food categories intakes were record. Exclusively vegetarian was not enrolled in this study. Healthy, age-matched children with no history of food allergy and those eating an unrestricted diet were recruited and used as healthy controls.

You may qualify if:

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

You may not qualify if:

• Exclusively vegetarian was not enrolled in this study.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

human feces, stool

MeSH Terms

Conditions

Hypersensitivity; Food Hypersensitivity

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrics, Chang Gung Children's Hospital, Chang Gung Memorial Hospital

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 5, 2022
• Study Start: August 1, 2016
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: July 5, 2022

Record last verified: 2022-06