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Research on the Correlation between Small Intestinal Bacterial Overgrowth and Functional Gastrointestinal Disorders

Research on the Correlation between Small Intestinal Bacterial Overgrowth (SIBO) and Functional Gastrointestinal Disorders: A Prospective Case-Control Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129685
Enrollment
Unknown
Registered
2026-08-07
Start date
2025-04-18
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Functional Gastrointestinal Disorders

Interventions

FGIDs Patient Group:None
Healthy Control Group:None

Sponsors

Hainan West Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: FGIDs Patient Group: 1. Aged 18-60 years, regardless of gender; inpatients and outpatients presenting at the Gastroenterology Department of our hospital, with a preliminary diagnosis of Functional Gastrointestinal Disorders (FGIDs) based on medical history and clinical symptoms. 2. Underwent complete gastroscopy and colonoscopy with no significant organic abnormalities; based on one-on-one clinical interviews and questionnaire surveys, the diagnostic results met the Rome IV criteria for at least one of the following functional gastrointestinal disorders: Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD), Functional Diarrhea (FDr), and Functional Constipation (FC). 3. Voluntarily agreed to participate in this study and signed the written informed consent form. Healthy Control Group: 1. Aged 18-60 years, regardless of gender; healthy individuals recruited from the Physical Examination Center of our hospital or the local community. 2. Underwent complete gastroscopy and colonoscopy with no significant organic abnormalities; based on one-on-one clinical interviews and questionnaire surveys, they did not meet the Rome IV criteria for any functional gastrointestinal disorders, and had no other digestive system diseases. 3. Voluntarily agreed to participate in this study and signed the written informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for FGIDs Patient Group: 1. Patients with severe cardiopulmonary dysfunction. 2. Patients with uncontrolled hypertension. 3. Patients with lactulose intolerance. 4. Pregnant or lactating women. 5. Patients with other severe diseases (including severe infection, severe cardiac, respiratory, renal, neuropsychiatric diseases, etc.) or complicated with active tumors. 6. Patients with psychiatric disorders that impede study cooperation, those unwilling to sign the written informed consent form, individuals concurrently enrolled in other clinical trials, as well as other patients deemed unsuitable for enrollment by the investigators. Exclusion Criteria for Healthy Control Group: 1. Individuals with severe cardiopulmonary dysfunction. 2. Individuals with uncontrolled hypertension. 3. Individuals with lactulose intolerance. 4. Pregnant or lactating women. 5. Individuals with other severe diseases (including severe infection, severe cardiac, respiratory, renal, neuropsychiatric diseases, etc.) or complicated with active tumors. 6. Individuals with psychiatric disorders that impede study cooperation, those unwilling to sign the written informed consent form, individuals concurrently enrolled in other clinical trials, as well as other individuals deemed unsuitable for enrollment by the investigators.

Design outcomes

Primary

MeasureTime frame
Hydrogen Concentration in Expired Breath;

Secondary

MeasureTime frame
Methane Concentration in Expired Breath;

Countries

China

Contacts

Public ContactPeng Cheng

Hainan West Central Hospital

imettoo@163.com+86 186 1689 4990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026