NCT03857425

Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims at evaluating efficacy Clostridum Butyricum Capsule and Bacillus Coagulans Tablets in H. pylori eradication. It is hypothesized that Clostridum Butyricum Capsule , Bacillus Coagulans Tablets monotherapy or Clostridum Butyricum Capsule plus Bacillus Coagulans may have some positive effect on H. pylori eradication.

Detailed description

The study will include three phases: screening, treatment and follow-up. Screening: during this phase subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations. Treatment: Subjects are randomly assigned to treatment and will be treated for 8weeks. Follow-up: includes one visits. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Conditions

• Gastritis
• H Pylori Infection
• Dyspepsia

Interventions

Type	Name	Description
DRUG	Clostridum Butyricum Capsule	Clostridum Butyricum Capsule 3\*420mg,twice daily for 8 weeks
DRUG	Bacillus Coagulans Tablets	Bacillus Coagulans Tablets 3\*350mg, three times daily for 8 weeks
DRUG	Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets	Clostridum Butyricum Capsule 3\*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3\*350mg, three times daily for 8 weeks

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-08-31
• Completion: 2019-09-15
• First posted: 2019-02-28
• Last updated: 2019-09-25

Locations

1 site across 1 country: China