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Effect of Vitamin D on Drug Resistant Helicobacter Pylori (HP) Eradication Study (vDHp)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03142620
Recruitment Status : Unknown
Verified May 2017 by Justin Che-Yuen Wu, Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Justin Che-Yuen Wu, Chinese University of Hong Kong

Brief Summary:

Background:

Helicobacter pylori infection, which affects over 50% of the global population, is one of the most prevalent infectious diseases in the world. H. pylori infection causes chronic active gastritis and is associated with peptic ulcer, lymphoma of the mucosa-associated lymphoid tissue and gastric cancer. The colonization of H. pylori in the hostile gastric environment is determined by the complex interactions among bacterial, environmental and host factors. Because of the emergence of antibiotic resistance and adverse drug reactions such as diarrhea, the successful rates with standard triple therapy for H. pylori eradication are falling.

Vitamin D or its analogues was found to induce autophagy in keratinocytes, macrophages, and various cancer cell types. Our preliminary findings indicated that 1α,25-dihydroxyvitamin D3 could induce cathelicidin expression and autophagy in cultured human gastric epithelial HFE-145 cells and reduced the intracellular survival of H. pylori in a co-culture system. It was also found that cathelicidin alone reduced the survival of drug-resistant strain of H. pylori. 1α,25-dihydroxyvitamin D3 also significantly reduced H. pylori colonization in mice, perhaps through the induction of cathelicidin in the stomach. These findings suggest that vitamin D not only could control H. pylori but also its drug-resistant strains in humans.

Emerging evidence suggest that vitamin D might be a cost-effective prophylactic and possibly therapeutic antimicrobial agent for the control and eradication of H. pylori. Since vitamin D acts through mechanisms independent of standard antibiotics, it is expected that vitamin D will be equally efficacious for controlling and eradicating drug-resistant strains of H. pylori. The investigators herein propose that vitamin D in combination of standard antimicrobial therapeutics could improve the eradication rates of drug-resistant H. pylori.


Condition or disease Intervention/treatment Phase
H. Pylori Infection Drug: Esomeprazole Drug: Amoxicillin-Potassium Clavulanate Combination Drug: Clarithromycin Drug: Vitamin D3 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delineation of Therapeutic Potential and the Causal Relationship Between Vitamin D and Helicobacter Pylori (HP) Infection and Gastritis
Study Start Date : March 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Triple Therapy 10 days
Esomeprazole 40mg, Amoxicillin-Potassium Clavulanate Combination 1000mg and clarithromycin 500mg for 10 days
Drug: Esomeprazole
40mg twice daily
Other Name: Nexium

Drug: Amoxicillin-Potassium Clavulanate Combination
1000mg twice daily
Other Name: Amoxicillin

Drug: Clarithromycin
500mg twice daily
Other Name: Klacid

Active Comparator: Triple Therapy 10 days+ vitamin D for 10

Esomeprazole 40mg, Amoxicillin-Potassium Clavulanate Combination 1000mg and clarithromycin 500mg for 10 days

+ vitamin D3 IU for 10 days

Drug: Esomeprazole
40mg twice daily
Other Name: Nexium

Drug: Amoxicillin-Potassium Clavulanate Combination
1000mg twice daily
Other Name: Amoxicillin

Drug: Clarithromycin
500mg twice daily
Other Name: Klacid

Drug: Vitamin D3
5000IU
Other Name: Cholecalciferol

Active Comparator: Triple Therapy 10 days+vitamin D for 28

Esomeprazole 40mg, Amoxicillin-Potassium Clavulanate Combination 1000mg and clarithromycin 500mg for 10 days

+ vitamin D3 IU for 28 days

Drug: Esomeprazole
40mg twice daily
Other Name: Nexium

Drug: Amoxicillin-Potassium Clavulanate Combination
1000mg twice daily
Other Name: Amoxicillin

Drug: Clarithromycin
500mg twice daily
Other Name: Klacid

Drug: Vitamin D3
5000IU
Other Name: Cholecalciferol




Primary Outcome Measures :
  1. The eradication status of H. pylori infection [ Time Frame: Week 4 ]
    The eradication status of H. pylori infection determined by histological examination of gastric tissues obtained by endoscopy at Week 4


Secondary Outcome Measures :
  1. Comparisons of the levels of 25-hydroxylvitamin D3 and 1,25-hydroxylvitamin D3, mRNA and protein expression of vitamin D receptors, CYP24A1, CYP27B1, vitamin-D binding protein and Cathelicidin before (Week 0) and after (Week 4) treatment [ Time Frame: Week 4 ]
    1. Plasma level of 25-hydroxylvitamin D3 by ELISA
    2. Gastric tissue levels of 1α,25-hydroxylvitamin D3 by ELISA
    3. Gastric mRNA and protein level of vitamin D receptors, CYP24A1, CYP27B1, vitamin-D binding protein and cathelicidin by Real Time-PCR and IHC.
    4. Clinical dyspeptic symptoms
    5. Gastric tissue of antibiotic resistant strains by antibiotic sensitivity test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with H. pylori infection who fails to eradicate by standard triple therapy as confirmed by Urea Breath Test. Age 18-80
  • Provision of written consent

Exclusion Criteria:

  • Current Use of Vitamin D supplement or any agents that can induce cathelicidin expression, e.g. butyrate related compounds
  • Subject of child-bearing potential who is pregnant or intends to become pregnant during the trial period,
  • Lactating female,
  • Known hypersensitivity to PPI or antibiotics,
  • Use of PPI or NSAID in the past 4 weeks,
  • Malignancy,
  • Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.

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): NCT03142620


Contacts
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Contact: Justin CY Wu, MBChB(CUHK) (852)3505 3476 justinwu@cuhk.edu.hk
Contact: Pui Kuan PK Cheong, Mphil (852)3505 3476 jcheong@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Justin C.Y. Wu, MBChB(CUHK)    (852)3505 3476    justinwu@cuhk.edu.hk   
Principal Investigator: Justin C.Y. Wu, MBChB(CUHK)         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Justin CY Wu, MBChB(CUHK) Chinese University of Hong Kong
Additional Information:
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Responsible Party: Justin Che-Yuen Wu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03142620    
Other Study ID Numbers: HPVD
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Justin Che-Yuen Wu, Chinese University of Hong Kong:
Drug resistant H.pylori infection
vitamin D
gastritis
Additional relevant MeSH terms:
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Infections
Vitamin D
Cholecalciferol
Amoxicillin
Clarithromycin
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Esomeprazole
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
beta-Lactamase Inhibitors