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A randomized, controlled clinical study of Bifidobacterium triple live bacteria enteric coated tablets (Bifid) combined with quadruple therapy for the treatment of Helicobacter pylori positive chronic gastritis.

A randomized, controlled clinical study of Bifidobacterium triple live bacteria enteric coated tablets (Bifid) combined with quadruple therapy for the treatment of Helicobacter pylori positive chronic gastritis.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085283
Enrollment
Unknown
Registered
2024-06-04
Start date
2024-06-10
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Helicobacter pylori positive chronic gastritis

Interventions

A Group:Bifidobacterium triple live bacteria enteric coated capsules 420mg Twice a day+Quadruple therapy
B Group:Bifidobacterium triple live bacteria enteric coated capsules 840mg Twice a day+Quadruple therapy
C Group:Quadruple therapy

Sponsors

The Fourth Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) HP positive chronic gastritis patients who meet the indications for HP eradication (2) All selected diagnoses must be obtained through gastroscopy examination (within 1 month) (3) Positive results in rapid urease test, urea breath test within 2 weeks before gastroscopy, or within 1 month after gastroscopy (4) Age range from 18 to 65 years old, regardless of gender (5) Has not received formal HP eradication treatment in the past (6) I haven't taken any probiotic preparations recently (7) Sign informed consent form

Exclusion criteria

Exclusion criteria: (1) Individuals who have used probiotics, antibiotics, bismuth supplements within 4 weeks prior to treatment, or who have used H2RA and PPI within 2 weeks prior to treatment; Long term use of non steroidal anti-inflammatory drugs in the past. (2) Pregnant or lactating women (3) The patient also has other serious diseases that affect the evaluation of this study, such as severe liver disease, heart disease, cerebrovascular disease, kidney disease, malignant tumors, and alcoholism (4) Individuals who are allergic to the drugs used in this study (5) Participated in other drug studies within the three months prior to using the investigational drug (6) Patients may not be able to express their complaints correctly, such as mental illness, severe neurosis, or inability to cooperate with this trial. (7) Patients with severe immunodeficiency who are prone to fungal infections

Design outcomes

Primary

MeasureTime frame
13 carbon breath test;Loss of appetite;Taste disorders;Early satiety;Nausea and vomiting;abdominal distension;abdominal pain;Acid reflux;Heartburn;diarrhea;constipation;fever;rash;Dizziness and headache;Compliance evaluation;Degree of symptom improvement;

Countries

China

Contacts

Public ContactKang Qile

the Fourth Affiliated Hospital of Nanchang University

1351146732@qq.com+86 188 7898 3433

Outcome results

None listed

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