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Refractory gastroesophageal reflux disease: clinical characteristics and mechanistic links to small intestinal bacterial overgrowth

Refractory gastroesophageal reflux disease: clinical characteristics and mechanistic links to small intestinal bacterial overgrowth

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112032
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Gastroesophageal reflux disease

Interventions

Observation group:None

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age requirement: >=18 years old; 2. Confirmed gastroesophageal reflux disease diagnosis: a) Endoscopically proven reflux esophagitis (Los Angeles classification grade B-D); b) Pathologic acid exposure (acid exposure time > 4%) or reflux episodes > 80 on 24-hour impedance-pH monitoring; 3. Persistent symptoms: Typical reflux symptoms (regurgitation, heartburn, or chest pain); 4. Completed optimal proton pump inhibitors (PPI) therapy (double-dose PPI for >= 8 weeks)

Exclusion criteria

Exclusion criteria: 1. Surgical history: Previous digestive tract surgery (excluding appendectomy or splenectomy); 2. Endoscopically Organic lesions (including Barrett's esophagus or reflux-induced esophageal stenosis); 3. Esophageal motility disorders (e.g., achalasia, Jackhammer esophagus); 4. Systemic comorbidities: Severe cardiac/hepatic/pulmonary/renal disorders, Hematologic/endocrine/neurologic diseases, Active mental illness; 5. Connective tissue disease and uncontrolled diabetes; 6. Special populations: Pregnancy/lactation; 7. Recent antibiotics/acid suppressants use (> 3 consecutive days in past month); 8. Recent probiotics/laxatives/prokinetics use (within 2 weeks); 9. Drug hypersensitivity: Rifaximin/rifamycin allergy history; 10. Declined informed consent.

Design outcomes

Primary

MeasureTime frame
Treatment response rate (defined as a >=50% reduction in RDQ score);

Countries

China

Contacts

Public ContactLiping Duan

Peking University Third Hospital

duanlp@bjmu.edu.cn+86 139 0100 9183

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026