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

Food Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05442658
• Other study ID #: CMRPG4C0061_CORPG3F0071-3F0073
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: June 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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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Related Conditions & MeSH terms

• Allergic Disorder
• Food Allergy in Children
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Microbiota

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microbiota	Taxonomy-based analyses were performed by classifying each sequence using the RDP Naïve Bayesian rRNA Classifier Version 2.5 program	"baseline, pre-intervention"
Primary	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"