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Completed

NCT Number: NCT03857425

Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Clostridum Butyricum Capsule

Drug

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

Bacillus Coagulans Tablets

Drug

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

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

Primary outcomes

  1. helicobacter pylori eradication H.pylori eradication

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2019
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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