Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy

NCT05237115 | Completed Phase 4

• 1 other identifier: K111111
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at evaluating efficacy and safety of probiotics combined with triple therapy (Clostridium butyricum capsule and Bacillus coagulans tablets, esomeprazole, clarithromycin and amoxicillin) versus bismuth-containing quadruple therapy (bismuth,esomeprazole,clarithromycin and amoxicillin) in H. pylori eradication. It is hypothesized that probiotics combined with triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

Conditions

Gastritis; Peptic Ulcer; Dyspepsia

Keywords

Helicobacter pylori; Probiotics-combining triple therapy; Bismuth-combining quadruple therapy

Outcome Measures

Primary Outcomes (1)

• helicobacter pylori eradication

  The primary end point of this study is H.pylori eradication,established by negative \[13C\] urea breath test 28 days after the end of eradication.

  28 days after treatment

Secondary Outcomes (2)

• symptoms effective rates

  14 days of treatment, and 28 days after treatment

• adverse events

  14 days of treatment, and 28 days after treatment

Study Arms (3)

Clostridium butyricum group

EXPERIMENTAL

given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Drug: Clostridium butyricum capsule; Drug: esomeprazole; Drug: amoxicillin; Drug: clarithromycin

Bacillus clotting group

EXPERIMENTAL

given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Drug: esomeprazole; Drug: amoxicillin; Drug: clarithromycin; Drug: Bacillus clotting

bismuth quadruple therapy

ACTIVE COMPARATOR

given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Drug: esomeprazole; Drug: amoxicillin; Drug: clarithromycin; Drug: Bismuth

Interventions

Clostridium butyricum capsule DRUG

Clostridium butyricum group: given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Clostridium butyricum group

esomeprazole DRUG

Esmeprazole 40mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

Also known as: Nexium

Bacillus clotting group; Clostridium butyricum group; bismuth quadruple therapy

amoxicillin DRUG

Amoxicillin 500 mg 2 capsules BID plus esmeprazole 40mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

Also known as: Amoxy ( Uni-Amocin )

Bacillus clotting group; Clostridium butyricum group; bismuth quadruple therapy

clarithromycin DRUG

Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 40mg 1tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or Bacillus coagulans tablets 350mg 3 capsules BID and Clostridium butyricum capsule 420mg 3 capsules BID as a dose given for bismuth-containing quadruple therapy or probiotics combined with triple therapy.

Bacillus clotting group; Clostridium butyricum group; bismuth quadruple therapy

Bacillus clotting DRUG

given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Bacillus clotting group

Bismuth DRUG

given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Also known as: Bitnal

bismuth quadruple therapy

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\~75,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 or allergies to research drugs.
• Substantial organ impairment(eg liver cirrhosis, uremia, etc.), 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).
• Definite diagnosis of gastroduodenal ulcer and MALT's lymphoma.
• Pregnant or lactating women.
• Underwent upper gastrointestinal Surgery.
• highly atypical hyperplasia, have symptom of dysphagia.
• Evidence of bleeding or iron eficiency 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).
• a person with a mental disorder
• Enrolled in other clinical trials in the past 3 months.
• Refusal to sign informed consent.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Gastritis; Peptic Ulcer; Dyspepsia

Interventions

Esomeprazole; Amoxicillin; Clarithromycin; Bismuth

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals

Study Officials

• Yongquan Shi, Ph. D

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

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: Professor/Chief Physician

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: February 11, 2022
• Study Start: May 5, 2020
• Primary Completion: December 5, 2020
• Study Completion: December 5, 2020
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

CN (1)