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A randomized, double-blind, controlled clinical study on the effect of Limosilactobacillus reuteri LR-G100 combined with bismuth quadruple therapy on Helicobacter pylori eradication

A randomized, double-blind, controlled clinical study on the effect of Limosilactobacillus reuteri LR-G100 combined with bismuth quadruple therapy on Helicobacter pylori eradication

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099092
Enrollment
Unknown
Registered
2025-03-18
Start date
2025-03-18
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Helicobacter pylori infection

Interventions

Bismuth quadruple regimen + placebo group:Esomeprazole 20mgBid + amoxicillin 1.0g Bid+ clarithromycin 500mg Bid+ bismuth potassium citrate 220mgBid The course of treatment was 2 weeks. For patients al
Placebo was given orally in maltodextrin-containing capsules once a day for 4 weeks
Bismuth quadruple regimen + inactive bacteria intervention group:Bismuth quadruplex program + inactivated bacteria intervention group: Esomeprazole 20mgBid + amoxicillin 1.0g Bid+ clarithromycin 500mg
Bismuth quadruple regimen +active bacteria intervention group:Esomeprazole 20mgBid + amoxicillin 1.0g Bid+ clarithromycin 500mg Bid+ bismuth potassium citrate 220mgBid for 2 weeks. For patients allerg

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >18 years old. 2.Confirmed Helicobacter pylori infection (C13/14 breath test, rapid urease test, pathological examination). 3.Subject is able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion criteria

Exclusion criteria: 1. Patients who have used antibiotics or probiotics within 4 weeks. 2.Pregnant and lactating women. 3.Use of PPI, H2R, bismuth preparations within 4 weeks 4.Failure of first-line treatment of Helicobacter pylori infection within 3 months. 5.Previous allergy to probiotics. 6.History of gastrointestinal surgery. 7.Patients with a history of acute gastroenteritis within 4 weeks. 8.Patients with serious heart, liver, kidney and other organs and systemic diseases. 9.There are other circumstances in which the investigational drug is not considered appropriate for use by the investigator.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Gastrointestinal symptom score;Quality of life score;Intestinal microecology;

Countries

China

Contacts

Public ContactWensong Ge

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

gewensong@xinhuamed.com.cn+86 158 0187 3708

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026