Allergic DisorderNCT05442658
Importance and Association of Gut Microbiota and Biochemical Metabolites on Children Allergic Disorder
An observational study of Allergic Disorder and Food Hypersensitivity, run by Chang Gung Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Disorder, Food Hypersensitivity, Food Allergy in Children
- What is being tested?
- Microbiota
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Children with immune tolerance; Children with food hypersensitivity Children with food allergy Children with allergic disorder Healthy volunteers (Children)
Who cannot join
- Exclusively vegetarian was not enrolled in this study.
- -
About this study
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.
Read the 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.
- Being tested
- Microbiota
- Keywords
- Food sensitization, Food hypersensitivity, Food allergy
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrobiotaOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiota
Taxonomy-based analyses were performed by classifying each sequence using the RDP Naïve Bayesian rRNA Classifier Version 2.5 program
Measured: "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.
Measured: "baseline, pre-intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Aug 2016
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DisorderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Chang Chen, MD, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442658
- Sponsor's protocol ID
- CMRPG4C0061_CORPG3F0071-3F0073
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance and Association of Gut Microbiota and Biochemical Metabolites on Children Allergic Disorder
- ClinicalTrials.gov ID
- NCT05442658
- Acronym / sponsor ID
- CMRPG4C0061_CORPG3F0071-3F0073
- Keywords
- Food sensitization, Food hypersensitivity, Food allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food hypersensitivity, Food allergy | – | Other: Microbiotayounger 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 | – | Other: MicrobiotaThe control children came from an age-matched cohort and did not exhibit allergic manifestations or increased total or specific IgE levels. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children with immune tolerance; Children with food hypersensitivity Children with food allergy Children with allergic disorder Healthy volunteers (Children)
Key exclusion criteria (2 listed)
- Exclusively vegetarian was not enrolled in this study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota | Other | Food hypersensitivity, Food allergy, Healthy control |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Disorder and Food Hypersensitivity, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiota (time frame: "baseline, pre-intervention"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.