A breath test for gut health in kids? study explores the possibility
NCT ID NCT07797491
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This study compares breath gases and gut bacteria between children with functional constipation and healthy children. Researchers measure exhaled nitric oxide, hydrogen sulfide, hydrogen, and methane, and analyze stool samples for microbiome composition. The goal is to see if breath gas patterns correlate with gut bacteria and constipation. If so, it could lead to a simple, non-invasive breath test for pediatric gut health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Breath gas analysis (nitric oxide, hydrogen sulfide, hydrogen, methane) and gut microbiome profiling
- What this could lead to
- If clear links emerge, doctors might use a simple breath test to assess gut health in children with constipation, avoiding invasive procedures.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. The findings may not lead to a practical test, and breath gas levels can vary for many reasons.
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
-
About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
Children aged 6 to 14 years recruited from the outpatient clinic of the Department of Pediatrics at Ruijin Hospital (North Campus), Shanghai, China. The study population includes two groups: (1) children diagnosed with functional constipation according to Rome criteria, and (2) healthy children undergoing routine health check-ups with no chronic or acute digestive disorders. All participants must have no recent (within 4 weeks) exposure to antibiotics, probiotics, or medications affecting gastrointestinal motility. Informed consent is obtained from the legal guardian of each participant.
- Ages
-
6 to 14 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Children aged 6 to 14 years, male or female. * Legal guardian provides written informed consent. * No use of antibiotics, probiotics, lactulose, antacids, or gastrointestinal prokinetic agents within 4 weeks prior to enrollment. * For the constipation group: Clinical diagnosis of functional constipation according to Rome criteria, defined as meeting at least two of the following criteria for two consecutive months: (a) fewer than two bowel movements per week; (b) at least one episode of fecal incontinence per week; (c) history of massive fecal retention or posturing related to fecal retention; (d) history of painful or difficult defecation; (e) presence of a large fecal mass in the rectum; (f) passage of stools large enough to obstruct the toilet. Additionally, no enema or acute enteritis within 2 weeks prior to enrollment. * For the healthy control group: No chronic digestive diseases or acute illnesses; no enema or acute enteritis within 2 weeks prior to enrollment. Exclusion Criteria: * Use of antibiotics, probiotics, lactulose, antacids, or gastrointestinal prokinetic agents within 4 weeks prior to enrollment (if not already excluded at screening). * Clinically significant abnormalities in liver, kidney, neurological, respiratory, or coagulation function as determined by the investigator. * Unstable vital signs. * Presence of other underlying systemic diseases (e.g., metabolic, endocrine, or organic gastrointestinal disorders). * Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
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Other studies related to the condition(s) this trial covers.
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