Obesity, ChildhoodMATOMSNCT04451148
Gut Microbiome and Obesity
An observational study of Obesity, Childhood and Metabolic Syndrome, run by Federico II University at 1 site in Italy.
Trial summary
Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor for various chronic non-communicable diseases. Metabolic syndrome (MS) is the name for a group of risk factors that increase cardiovascular risk and other health problems characterized by the presence of abdominal obesity… Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Obesity, Childhood, Metabolic Syndrome
- What is being tested?
- Obese with or without metabolic syndromesubjects
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2020to 1 May 2022
- 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 10 to 16 years
- All sexes
- Child
Study population: Children/adolescents of both sexes, aged between 10-16 years, with obesity, obesity complicated by metabolic syndrome and healthy controls observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II)
Who may be able to join
- Subjects aged between 10-16 years,
- diagnosis of obesity or obesity complicated by metabolic syndrome
- healthy controls
Who cannot join
- Age at enrollment < 10 or >16 years,
- concomitant presence of chronic diseases,
- neoplasms,
- immunodeficiencies,
- chronic infections,
- autoimmune diseases,
Show all 15Show fewer
- chronic inflammatory bowel diseases,
- celiac disease, -genetic-metabolic diseases, -
- cystic fibrosis
- chronic lung diseases,
- malformations of the cardiovascular/respiratory/gastrointestinal system,
- neuropsychiatric disorders
- neurological pathologies,
- assumption of antibiotics and/or pre/pro/synbiotics
- onset of diarrhea or acute gastrointestinal disease during the 12 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Naples Federico II
Naples, 80131
Roberto Berni Canani, MD, PhD, +390817462680, berni@unina.it
About this study
Official title: Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome
Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor for various chronic non-communicable diseases. Metabolic syndrome (MS) is the name for a group of risk factors that increase cardiovascular risk and other health problems characterized by the presence of abdominal obesity, dyslipidemia, hyperglycaemia and high blood pressure. Numerous preclinical and clinical data suggest a potential role of the intestinal microbiota in these diseaes. Unfortunately, comparative studies of the gut microbiota are still scarce in pediatric subjects suffering from obesity than obesity complicated by MS. The aim is to study the metagenomics and metabolomics characteristics of the intestinal microbiota in obese children/adolescents with or without MS, that could provide useful data for innovative intervention strategies for these conditions.
- Conditions
- Obesity, Childhood, Metabolic Syndrome
- Being tested
- Obese with or without metabolic syndromesubjects
- Medical subject headings
- Pediatric Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obese with or without metabolic syndromesubjectsOther
Children with obesity and with or without metabolic syndrome
| Study group | Role | What they receive |
|---|---|---|
| Obese subjects | Subjects with obesity Receives: Other: Obese with or without metabolic syndromesubjects | |
| Obese plus metabolic syndrome subjects | Subjects with obesity and metabolic syndrome Receives: Other: Obese with or without metabolic syndromesubjects | |
| Healthy controls | Otherwise healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Evaluation of gut microbiota composition
Measured: at enrollment
Secondary outcomes (4)
Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Evaluation of butyrate
Measured: at enrollment
Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Evaluation of acetate
Measured: at enrollment
Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Evaluation of propionate
Measured: at enrollment
Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Evaluation of indole
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 May 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451148
- Sponsor's protocol ID
- 103/20
- Acronym
- MATOMS
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04451148
- Acronym / sponsor ID
- MATOMS / 103/20
- Conditions
- Obesity, Childhood, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 30 Jun 2020 (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.
Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor for various chronic non-communicable diseases. Metabolic syndrome (MS) is the name for a group of risk factors that increase cardiovascular risk and other health problems characterized by the presence of abdominal obesity, dyslipidemia, hyperglycaemia and high blood pressure. Numerous preclinical and clinical data suggest a potential role of the intestinal microbiota in these diseaes. Unfortunately, comparative studies of the gut microbiota are still scarce in pediatric subjects suffering from obesity than obesity complicated by MS. The aim is to study the metagenomics and metabolomics characteristics of the intestinal microbiota in obese children/adolescents with or without MS, that could provide useful data for innovative intervention strategies for these conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese subjects | – | Other: Obese with or without metabolic syndromesubjectsSubjects with obesity |
| Obese plus metabolic syndrome subjects | – | Other: Obese with or without metabolic syndromesubjectsSubjects with obesity and metabolic syndrome |
| Healthy controls | – | –Otherwise healthy subjects |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Children/adolescents of both sexes, aged between 10-16 years, with obesity, obesity complicated by metabolic syndrome and healthy controls observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II)
Key inclusion criteria (3 listed)
- Subjects aged between 10-16 years,
- diagnosis of obesity or obesity complicated by metabolic syndrome
- healthy controls
Key exclusion criteria (15 listed)
- Age at enrollment < 10 or >16 years,
- concomitant presence of chronic diseases,
- neoplasms,
- immunodeficiencies,
- chronic infections,
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 |
|---|---|---|
| Obese with or without metabolic syndromesubjectsChildren with obesity and with or without metabolic syndrome | Other | Obese plus metabolic syndrome subjects, Obese subjects |
Primary outcome
Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Time frame: at enrollment
Evaluation of gut microbiota composition
4 secondary outcomes
Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Time frame: at enrollment
Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Time frame: at enrollment
Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Time frame: at enrollment
Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
Time frame: at enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood and Metabolic Syndrome, run by Federico II University at 1 site in Italy.
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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls (time frame: at enrollment). 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 7 Jul 2020; AzTrials last refreshed its copy on 2 Nov 2026.