Effect of Vitamin D on Drug Resistant Helicobacter Pylori (HP) Eradication Study
vDHp
Delineation of Therapeutic Potential and the Causal Relationship Between Vitamin D and Helicobacter Pylori (HP) Infection and Gastritis
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 5, 2017
May 1, 2017
2.8 years
February 9, 2015
May 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The eradication status of H. pylori infection
The eradication status of H. pylori infection determined by histological examination of gastric tissues obtained by endoscopy at Week 4
Week 4
Secondary Outcomes (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
Week 4
Study Arms (3)
Triple Therapy 10 days
ACTIVE COMPARATOREsomeprazole 40mg, Amoxicillin-Potassium Clavulanate Combination 1000mg and clarithromycin 500mg for 10 days
Triple Therapy 10 days+ vitamin D for 10
ACTIVE COMPARATOREsomeprazole 40mg, Amoxicillin-Potassium Clavulanate Combination 1000mg and clarithromycin 500mg for 10 days \+ vitamin D3 IU for 10 days
Triple Therapy 10 days+vitamin D for 28
ACTIVE COMPARATOREsomeprazole 40mg, Amoxicillin-Potassium Clavulanate Combination 1000mg and clarithromycin 500mg for 10 days \+ vitamin D3 IU for 28 days
Interventions
40mg twice daily
1000mg twice daily
500mg twice daily
5000IU
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong, Hong Kong
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin CY Wu, MBChB(CUHK)
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 9, 2015
First Posted
May 5, 2017
Study Start
March 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 5, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share