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Multicenter, randomized, open controlled study of standard PPI triple therapy combined with Bioflor for Hp eradication

Multicenter, randomized, open controlled study of standard PPI triple therapy combined with Bioflor for Hp eradication

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008610
Enrollment
Unknown
Registered
2016-06-07
Start date
2016-07-11
Completion date
Unknown
Last updated
2017-11-27

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

Conditions

Helicobacter pylori infection

Interventions

Group A:Bioflor+Rabeprazole+Amoxicillin+Clarithromycin (d1~d10), Bioflor (d11~d14)
Group B:Rabeprazole+Bismuth potassium citrate+Amoxicillin+Clarithromycin (d1~d10)
Group C:Rabeprazole+Amoxicillin+Clarithromycin (d1~d10)

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Hp positive NUD patients in line with HP eradication indications; (2) All selected candidates must obtain a diagnosis by endoscopy (within 1 month); (3) the rapid urease test was positive, or urea breath test was positive within 2 weeks before endoscopy or within 1 month after endoscopy; (4) Aged 18 to 65 years old, male or female; (5) Havnt received formal HP eradication therapy; (6) Havnt taking any probiotic recently; (7) Signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Have taken antibiotics or bismuth agent within 4 weeks before treatment, or have taken H2RA or PPI within 2 weeks before treatment; (2) Pregnancy or breast-feeding women; (3) Patients have any other serious illness that would affect the study, such as severe liver disease, heart disease, cerebrovascular disease, kidney disease, cancer or alcoholism disorders; (4) Allergy to drugs using in this study; (5) Have participated in other drug study within 3 months before this trial; (6) Patients who is unable to express their main complaint properly, such as psychosis, severe neurosis or who cannot cooperate in this trial; (7) Patients with severe immune deficiencies or easily lead to fungal infections.

Design outcomes

Primary

MeasureTime frame
Hp eradication rate;

Secondary

MeasureTime frame
epigastric distention;belching;epigastric pain;poor appetite;diarrhea;

Countries

China

Contacts

Public ContactFulian Hu

Peking University First Hospital

djjyhu@163.com+86 13651136860

Outcome results

None listed

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