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Gut microbes and inflammation: the hidden clues in childhood obesity

NCT ID NCT05920785

NEW Knowledge-focused Sponsor: Samara State Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 16, 2026 · Last updated Oct 16, 2026

Summary

Researchers at Samara State Medical University are studying school-age children with obesity to understand how their clinical, metabolic, immune, and gut microbe profiles relate to one another. The study enrolls 50 children aged 7 to 16, plus a small group of healthy children of similar age for comparison. Participants undergo blood tests, stool analysis for gut bacteria, and other standard checks, and some are followed for six months while receiving usual care such as diet and exercise guidance. The goal is to find markers that might help doctors tailor obesity management for children.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the study identifies markers tied to metabolic syndrome, doctors could one day use them to spot which obese children face the highest risk and tailor their care earlier.
What could go wrong
This is a small observational study of 50 children at one center, so any patterns may not hold for all children with obesity. It tests no treatment, so it cannot show that any therapy works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

50 people

The number who actually took part.

Started

Apr 2023

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

a group of obese school-age children (n=120) with the study of their clinical, metabolic, immunological and microbiological status. The control group will consist of healthy children of the appropriate age who are not overweight (n= 20).

Ages

7 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The presence of a diagnosis of "obesity of egzogenic-constitutional genesis" (according to the criteria of WHO anthropometric standards with the calculation of the standard sigma deviation - SDS using the WHO-AnthroPlus program). 2. The age of children from 7 to 16 years inclusive. 3. Absence of clinically significant concomitant somatic diseases that have a potential impact on the growth, weight and physical development of the child, as well as syndromic or monogenic forms of obesity (Prader-Willi syndrome, Alstrom, etc.) 4. The availability of voluntary informed consent of the legal representative or a child (over 14 years old) for the processing, storage and analysis of personal data obtained during the study. Exclusion Criteria: 1. The presence in the anamnesis of any acute infectious diseases, exacerbations of chronic infectious diseases, as well as concomitant diseases affecting the physical development of the child. 2. The presence of syndromic and monogenic forms of obesity. 3. Taking medications that affect the child's appetite (glucocorticosteroids, neuroleptics, antidepressants, etc.). 4. Lack of signed informed consent for inclusion in the study.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Pediatric Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Samara State Medical University

    Samara, Samara Oblast, 443079, Russia

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