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Study on the effects of prebiotic-and-probiotic fermented milk combined with Helicobacter pylori eradication treatment on gastrointestinal and oral flora

Study on the effects of prebiotic-and-probiotic fermented milk combined with Helicobacter pylori eradication treatment on gastrointestinal and oral flora

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094737
Enrollment
Unknown
Registered
2024-12-26
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Helicobacter pylori infection

Interventions

Standard treatment group:Patients in the standard treatment group were treated with standard eradication therapy for 2 weeks, and UBT was re-examined after 4 weeks of drug withdrawal
Concomitant treatment group:The fermented milk was taken at the same time as the eradication treatment drug for 2 weeks, and the UBT was re-examined 4 weeks after all treatment.
Sequential treatment group:The fermented milk was taken for 2 weeks before standard eradication therapy, and the UBT was re-examined 4 weeks after all drugs was stopped

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Treatment-naïve (untreated) patients with Hp infection diagnosed by molecular pathology or C13 breath test (13C-UBT); (2) Age 18-75 years old; (3) Agree and conditionally retain fecal and saliva samples; (4) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Severe liver and kidney insufficiency, cardiopulmonary insufficiency, malignant tumors, autoimmune diseases, mental or cognitive dysfunction; (2) Patients with gastric or esophageal surgery; (3) Pregnant and lactating women (women of childbearing age should take contraceptive measures during medication); (4) Known allergy to one or more of P-CAB and bismuth; (5) Use of antibiotics, bismuth, probiotics within 4 weeks or H2 receptor antagonists, proton pump inhibitors (PPIs) or P-CABs within 2 weeks.

Design outcomes

Primary

MeasureTime frame
Changes in intestinal and oral microbiota composition and metabolites;

Secondary

MeasureTime frame
Eradication rates;GSRS score;

Countries

China

Contacts

Public ContactShiyu Du

China-Japan Friendship Hospital

dushiyu1975@126.com+86 139 1153 1937

Outcome results

None listed

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