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

June 30, 2022 updated by: Chien-Chang Chen, MD, Chang Gung Memorial Hospital

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microbiota
Time Frame: "baseline, pre-intervention"
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
Time Frame: "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.
"baseline, pre-intervention"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

July 31, 2019

Study Completion (ACTUAL)

July 31, 2019

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (ACTUAL)

July 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CMRPG4C0061_CORPG3F0071-3F0073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Food Hypersensitivity

Clinical Trials on Microbiota

3
Subscribe