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Study on the adjuvant role of probiotics in anti-Helicobacter pylori therapy

Study on the adjuvant role of probiotics in anti-Helicobacter pylori therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071514
Enrollment
Unknown
Registered
2023-05-17
Start date
2023-05-11
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Helicobacter pylori infection

Interventions

Intervention group (probiotics + quadruple therapy):Probiotic intervention group + Standard bismuth quadruple therapy
Placebo group:Oral placebo for 6 weeks + Standard bismuth quadruple therapy

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Age is 18-60 years old, gender is not limited; (2) Permanent residents who have lived in the local area for more than half a year; (3) Hp infection (positive 13C or 14C urea breath test); (4) Patients with upper gastrointestinal symptoms, such as: abdominal pain, bloating, belching, acid reflux, heartburn, etc.; (5) have not previously received HP eradication therapy; (6) During the trial, participants agree not to take any drugs, supplements, or other dairy products, including yogurt drinks; Willing to comply with all test requirements and procedures; Willing to participate in other interventional clinical studies during the trial period; Be able to fully understand the nature, purpose, benefits, and possible risks and side effects of this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who have a history of allergy to any drug in this study; (2) Have recently (within 4 weeks) taken H2receptor antagonist (H2RA), Proton pump inhibitor (PPI) and other drugs used in eradication programs; (3) previous history of long-term use of nonsteroidal anti-inflammatory drugs; (4) Severe heart and lung diseases, and liver and kidney insufficiency; (5) Patients with malignant tumors; (6) Those with a history of upper gastrointestinal surgery; (7) pregnant or lactating women; (8) Those with poor compliance and unable to cooperate with the clinical research; (9) Patients who are participating in other clinical trials; Those who do not meet the inclusion criteria, do not eat in accordance with the regulations, and the incomplete information affects the judgment of the effect.

Design outcomes

Primary

MeasureTime frame
Rate of adverse effect;Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Changes in the intestinal flora;Serum C-reactive protein levels;Procalcitonin level;Liver function;Kidney function;

Countries

China

Contacts

Public ContactWu Peiying

Shanghai General Hospital

13361879197@163.com+86 133 6187 9197

Outcome results

None listed

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