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Probiotics in the Reduction of Adverse Effects and Dysbiosis of H. Pylori Eradication

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ClinicalTrials.gov Identifier: NCT03722433
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
The investigators aimed to assess the effect of probiotic supplementation with Vigiis 101-LAB during H. pylori eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Vigiis 101-LAB and sequential therapy Drug: Placebo and sequential therapy Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Efficacy of Probiotic Supplementation in the Reduction of Adverse Effects and Dysbiosis of Helicobacter Pylori Eradication Therapy - A Double Blind, Multi-center Randomized, Placebo Controlled Trial
Actual Study Start Date : August 29, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020

Arm Intervention/treatment
Experimental: probiotic plus 14-day sequential therapy
D1-D56: probiotics 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Drug: Vigiis 101-LAB and sequential therapy
Vigiis 101-LAB is the probiotic containing Lactobacillus paracasei subsp. Paracasei, which is the isolate from Taiwanese by Prof. Pan. This strain is resistant to gastric acid and bile acid. Therefore, its survival rate in the gastrointestinal tract could be as high as 95%. Previous studies showed that Vigiis 101-LAB can modulate the gut microbiota, with 10% increase in Bifidobacterium species and 20% reduction in Clostridium difficile.

Placebo Comparator: placebo plus 14-day sequential therapy
D1-D56: placebo 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Drug: Placebo and sequential therapy
Placebo without Vigiis 101-LAB component




Primary Outcome Measures :
  1. Incidence of adverse effects in the first line therapy in the two treatment groups [ Time Frame: 8 weeks ]
    At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events and compliance at the end of treatment. Patients with low compliance as defined by taking less than 80% of the pills and those lost to follow up will be excluded from the per-protocol analysis.


Secondary Outcome Measures :
  1. Eradication rates in the first line treatment in the two treatment groups [ Time Frame: 6 weeks ]
    Urea breath testing will be done at least 6 weeks after completion of eradication therapy.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment.

Exclusion Criteria:

  • children and teenagers aged less than 20 years
  • history of gastrectomy
  • gastric malignancy, including adenocarcinoma and lymphoma
  • previous allergic reaction to antibiotics (amoxicillin, metronidazole, clarithromycin, probiotics) and PPI (esomeprazole)
  • contraindication to treatment drugs
  • pregnant or lactating women
  • severe concurrent disease
  • concomitant use of clopidogrel
  • unwilling to accept random assignment of subjects

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): NCT03722433


Contacts
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Contact: Jyh-Ming Liou, MD 23123456 ext 63541 jyhmingliou@gmail.com

Locations
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Taiwan
Jyh-Ming Liou Recruiting
Taipei, Taiwan, Taiwan, 10002
Contact: Jyh-Ming Liou       jyhmingliou@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03722433     History of Changes
Other Study ID Numbers: 201706036MIPA
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Helicobacter Infections
Dysbiosis
Gram-Negative Bacterial Infections
Bacterial Infections
Pathologic Processes