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Clinical Trials in China / NCT07797491
Active, not recruiting Observational

Breath Gases, Gut Flora, and Immunity in Children With Constipation

NCT07797491 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Observational
Started
2026-01-01
Last updated
2026-09-01

Condition(s) studied

Constipation - Functional

Study summary

Constipation is a common problem in children that can affect their daily life, school performance, and social activities. Researchers have found that the bacteria living in our intestines (called "gut microbiome") may play an important role in constipation. However, we still do not fully understand exactly how these bacteria affect constipation in children.

This study aims to explore whether the gases children breathe out-including nitric oxide (NO), hydrogen sulfide (H₂S), hydrogen (H₂), and methane (CH₄)-can tell us something about the bacteria in their guts. By comparing children with constipation to healthy children, we hope to find out:

Whether the gases in their breath are different Whether the types of bacteria in their guts are different Whether there is a relationship between breath gases and gut bacteria If we find clear connections, this could lead to a simple, non-invasive breath test that doctors can use to understand a child's gut health without the need for more invasive procedures.

Eligibility

Sex
ALL
Min age
6 Years
Max age
14 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital Shanghai Shanghai Municipality

More Ruijin Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07797491 on ClinicalTrials.gov ↗ ← All trials in China