Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

NCT03857425 | Completed Phase 4

• 1 other identifier: KY20192009-F-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastritis; H Pylori Infection; Dyspepsia

Keywords

Gastritis; H Pylori Infection

Outcome Measures

Primary Outcomes (1)

• helicobacter pylori eradication H.pylori eradication

  Rate of H.pylori eradication Assessed by urea breath test，rapid urease test or helicobacter pylori stool antigen test after the end of treatment.

  8 weeks

Study Arms (3)

Clostridum Butyricum Capsule

EXPERIMENTAL

Clostridum Butyricum Capsule 3\*420mg, twice daily for 8 weeks

Drug: Clostridum Butyricum Capsule

Bacillus Coagulans Tablets

EXPERIMENTAL

Bacillus Coagulans Tablets 3\*350mg, three times daily for 8 weeks

Drug: Bacillus Coagulans Tablets

Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets

EXPERIMENTAL

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

Drug: Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets

Interventions

Clostridum Butyricum Capsule DRUG

Clostridum Butyricum Capsule 3\*420mg,twice daily for 8 weeks

Clostridum Butyricum Capsule

Bacillus Coagulans Tablets DRUG

Bacillus Coagulans Tablets 3\*350mg, three times daily for 8 weeks

Bacillus Coagulans Tablets

Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets DRUG

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

Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18\~70,both gender.
• Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
• Patients are willing to receive eradication treatment.
• Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

You may not qualify if:

• Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
• Contraindications to study drugs.
• Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
• Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
• Pregnant or lactating women.
• Patients were diagnosed with gastroduodenal ulcer and MALT lymphoma.
• Underwent upper gastrointestinal Surgery.
• Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
• Evidence of bleeding or iron efficiency anemia.
• A history of malignancy.
• Drug or alcohol abuse history in the past 1 year.
• Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
• Enrolled in other clinical trials in the past 3 months.
• Patients who has psychological problem or poor compliance.
• Refuse to sign informed consent.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Zhang J, Guo J, Li D, Chen M, Liu J, Feng C, He Q, Zhao J, Zhang L, Chen J, Shi Y. The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study. Medicine (Baltimore). 2020 Nov 6;99(45):e22976. doi: 10.1097/MD.0000000000022976.

  PMID: 33157939 DERIVED

MeSH Terms

Conditions

Gastritis; Dyspepsia

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: March 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: September 15, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)