Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 228 for:    yeast

Evaluation of Saccharomyces Boulardii Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688828
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
Wuhan Union Hospital, China
Xiaogan Central Hospital
Xiaogan First People's Hospital
Hubei Aerospace Hospital
The third people's Hospital of Hubei Province
Wuhan University
Anlu Puai Hospital
Information provided by (Responsible Party):
Bin Cheng, Tongji Hospital

Brief Summary:
The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therap.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Saccharomyces boulardii Drug: Esomeprazole Drug: Amoxicillin Drug: Clarithromycin Drug: Bismuth potassium citrate Not Applicable

Detailed Description:
In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Several studies previously suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events with PPI-based triple therapy. But, their effect for eradication of Hp is not yet conclusive. And the experiments now available about efficacy of Saccharomyces Boulardii were mainly combined with triple therapy. The aims of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 776 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation of Saccharomyces Boulardii Sachets Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori: a Prospective, Multi-Center Trial
Actual Study Start Date : November 11, 2018
Estimated Primary Completion Date : October 10, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Probiotics
Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Drug: Saccharomyces boulardii
500mg bid
Other Name: Brad's yeast powder;Biocodex, Paris, France

Drug: Esomeprazole
20mg bid

Drug: Amoxicillin
1.0g bid

Drug: Clarithromycin
0.5g bid

Drug: Bismuth potassium citrate
0.22g bid

Active Comparator: Quadruple Therapy
Esomeprazole + Amoxicillin + Clarithromycin + Bismuth potassium citrate
Drug: Esomeprazole
20mg bid

Drug: Amoxicillin
1.0g bid

Drug: Clarithromycin
0.5g bid

Drug: Bismuth potassium citrate
0.22g bid




Primary Outcome Measures :
  1. Helicobacter pylori eradication [ Time Frame: 6 weeks after treatment initiation ]
    to investigate the efficacy of Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple therapy.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 2 weeks and 4-12 weeks after treatment initiation ]
    to investigate the efficacy of Saccharomyces Boulardii sachets for reduction of incidence of adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Helicobacter pylori infected patients
  • 13C DOB>8
  • age 22~65

Exclusion Criteria:

  • prior Hp eradication therapy including amoxicillin and clarithromycin
  • previous gastric resection
  • allergic to the drugs used in this study
  • previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study
  • Patients who were pregnant or lactating
  • Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy,diabete mellitus, hypertension…) effect the evaluation of this study
  • Can't express the complaint correctly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688828


Contacts
Layout table for location contacts
Contact: Bin Cheng, Doctor 027-83663334 bcheng@tjh.tjmu.edu.cn
Contact: Yuchong Zhao, Doctor 027-83663334 zhaoyuchongtj@163.com

Locations
Layout table for location information
China, Hubei
Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Yuchong Zhao, Doctor    13006128635    zhaoyuchongtj@163.com   
Contact: Bin Cheng, Professor    +86 27 83663595    b.cheng@tjh.tjmu.edu.cn   
Sponsors and Collaborators
Huazhong University of Science and Technology
Wuhan Union Hospital, China
Xiaogan Central Hospital
Xiaogan First People's Hospital
Hubei Aerospace Hospital
The third people's Hospital of Hubei Province
Wuhan University
Anlu Puai Hospital
Investigators
Layout table for investigator information
Principal Investigator: Bin Cheng, Doctor Tongji Hospital
Study Chair: Yuchong Zhao, Doctor Tongji Hospital

Publications:
Layout table for additonal information
Responsible Party: Bin Cheng, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03688828     History of Changes
Other Study ID Numbers: BoulardiitoHp2018
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bin Cheng, Tongji Hospital:
Saccharomyces Boulardii
Standard Quadruple Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Amoxicillin
Clarithromycin
Potassium Citrate
Esomeprazole
Bismuth
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents