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Effect of probiotics on symptom and gut microbiota in rabeprazole treated patients with gastroesophageal reflux: A randomized, double-blind, placebo-controlled study

Effect of probiotics on symptom and gut microbiota in rabeprazole treated patients with gastroesophageal reflux: A randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038409
Enrollment
Unknown
Registered
2020-09-22
Start date
2021-05-16
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

gastroesophageal reflux

Interventions

experimental group:1-8 weeks: Rabeprazole and probiotics
9-12 weeks: probiotics
control group:1-8 weeks: Rabeprazole and probiotics placebo
9-12 weeks: probioics placebo

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The following conditions satisfy one of them (1) Esophagitis was detected by gastroscopy in domestic tertiary hospitals within the past 3 months (2) Esophagitis wasnt detected by gastroscopy in domestic tertiary hospitals within the past 3 months, but patients have Symptoms of heartburn, acid reflux, and posterior sternal burning, etc., and the score of Reflux diagnostic questionnaire is >= 12; 2. Age is from 18 to 65 years; both male or female can be included; 3. Sign informed Consent.

Exclusion criteria

Exclusion criteria: 1. In the recent two weeks, patients took gastroesophageal reflux disease treatment drugs (including acid inhibitors, antacids, power promoting drugs, gastric mucosa protective agents and Traditional Chinese medicine, etc.), probiotics and probiotic-related preparations. 2. Complicated with any of the following symptoms or diseases: (1) Hepatic insufficiency, which is defined as aminotransferase (AST) greater than 2 x ULN (upper limit of normal value); (2) Renal insufficiency, defined as serum creatinine (Scr) > ULN; (3) Patients with heart failure and abnormal electrocardiogram; 3. Gastroscopy in domestic tertiary or higher hospitals revealed any of the following diseases within the last 2 months: peptic ulcer, bleeding, gastritis, esophageal and gastric varices, upper gastrointestinal malignant lesions; 4. Patients with myocardial infarction, stroke or malignant tumor; 5. A history of gastroesophageal or duodenal surgery; 6. Recent preparing for pregnancy (including male and female), pregnant or lactating women; 7. Uncooperative patients, such as unwilling to provide personal information, cannot understand informed consent; 8. Allergic to study drugs (rabeprazole) or probiotics. 9. Esophagitis caused by gastric retention and pyloric obstruction.

Design outcomes

Primary

MeasureTime frame
the score of Reflux diagnostic questionnaire;

Secondary

MeasureTime frame
gut microbiota analysis: Intestinal flora diversity;the score of Gastrointestinal Symptom Rating Scale questionnaire;Fecal metabolomics analysis: differences in fecal metabolites and metabolic pathways;body mass index;Changes in grading of esophagitis;

Countries

China

Contacts

Public ContactLyu Nonghua

The First Affiliated Hospital of Nanchang University

lunonghua@163.com+86 791 8869 2705

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026