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Exploring the intestinal microbiological mechanism underlying the efficacy of stress-based mindfulness intervention in treating functional gastrointestinal disorders in children

Exploring the intestinal microbiological mechanism underlying the efficacy of stress-based mindfulness intervention in treating functional gastrointestinal disorders in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119937
Enrollment
Unknown
Registered
2026-03-05
Start date
2026-03-05
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rome-IV functional gastrointestinal disorders (FGIDs)

Interventions

Control group :The control group undertakes an identical time-frequency schedule of progressive muscle relaxation and guided imagery exercises (same instructor, same

Sponsors

Beijing Childrens Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria (all must be met simultaneously): 1. Age 8-12 years old, gender not restricted; 2. Meet the diagnostic criteria for functional gastrointestinal disorders in children according to the Rome IV criteria: 1) Functional abdominal pain disorder: Abdominal pain does not meet the diagnostic criteria for other functional gastrointestinal disorders; the pain is not related to eating or defecation; the symptoms persist for at least 2 months, with at least 4 occurrences per month; 2) Irritable bowel syndrome: At least 4 days of abdominal pain per month; accompanied by at least two of the following: related to defecation, change in defecation frequency, change in stool consistency; the symptoms persist for at least 2 months, with at least 4 occurrences per month; 3) Functional dyspepsia: Post-meal fullness, early satiety, upper abdominal pain or burning sensation, at least 4 days per month; the symptoms are not related to defecation; the symptoms persist for at least 2 months; 4) Abdominal migraine: At least 2 occurrences in the past 6 months; episodic, severe periumbilical or midline abdominal pain, lasting for 1 hour or more; no symptoms between attacks; often accompanied by nausea, vomiting, photophobia, etc. 3. Guardians and children give informed consent and voluntarily participate in this study; 4. Have basic reading and writing skills in Chinese and can cooperate to complete scale assessment and intervention training. Whether you can participate in the study requires final decision by a doctor after examination.

Exclusion criteria

Exclusion criteria: Exclusion criteria (any one of the following conditions will disqualify one from participating): 1. Having severe organic diseases (such as inflammatory bowel disease, metabolic diseases, neurological disorders, etc.); 2. Having a clear diagnosis of mental disorder at present or in the past (such as depression, anxiety disorder, autism spectrum disorder, etc.); 3. Having received systematic psychological treatment or participated in other intervention-based clinical studies in the recent 3 months; 4. The researcher deems that there are any other circumstances that make one ineligible to participate in this study.

Design outcomes

Primary

MeasureTime frame
Salivary cortisol level;

Secondary

MeasureTime frame
Adverse reactions related to mindfulness practice;Diary of Abdominal Pain Symptoms;Serious Adverse Event (SAE);SCARED Anxiety Scale Score;Vital signs;Children's Blood Pressure Scale Score;DSRSC Depression Scale Score;Adverse event;Intestinal microbiota alpha diversity;

Countries

China

Contacts

Public ContactYing Li

Beijing Childrens Hospital,Capital Medical University

liying@bch.com.cn+86 10 59617496

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026