Investigator(s)
| Submitter |
Passang Lhamo Sherpa Faculty of Nursing and Public Health, KGUMSB. Bhutan Faculty of Medicine, Oita University, Japan Passang Lhamo Sherpa 
|
| Principal Investigator |
Passang Lhamo Sherpa Faculty of Nursing and Public Health, KGUMSB. Bhutan Faculty of Medicine, Oita University, Japan Passang Lhamo Sherpa
|
| Co-Investigator(s) |
Takashi Matsumoto Oita University Takashi Matsumoto
|
| Co-Investigator(s) |
Guru Prasad Dhakal JDWNRH, KGUMSB Guru Prasad Dhakal
|
| Co-Investigator(s) |
Sangay Zangmo RCDC Sangay Zangmo
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| Co-Investigator(s) |
Chimi Dorji RCDC Chimi Dorji
|
Title(s) and abstract
| Scientific title | Evaluation of Immunochromatography stoll antigen test kit for detection of Helicobacter pylori infection and antibiotic adherance study |
| Public title | Detection of Helicobacter pylori infection and antibiotic adherance study |
| Background | Helicobacter pylori (H. pylori) is now confirmed as one of the causative factors for gastric cancer. Infection usually occurs during childhood and once infected, the human body cannot naturally eliminate the bacterium without appropriate antimicrobial therapy. The bacterium is a highly heterogeneous organism from which many virulence factors have been associated with development of gastric diseases including gastric cancer. Besides H. pylori being carcinogenic on its own, recent research reported that individuals with both an inherent pathogenic variant gene and H. pylori infection have more than 45% lifetime risk for developing gastric cancer. Additionally, individuals, without the mutations but with H. pylori infection faces more than 14% of the same risk. These findings underscore the importance of H. pylori eradication as a primary prevention strategy in preventing the burden of gastric cancer. Stool antigen test detects active infection in individuals and are recommended for screen and treat program. |
| Objectives | Therefore, the objective of this study is to detect H. pylori infections among Thimphu residence using immunochromatography test kit (ICT) for stool antigen and to evaluate the adherence to the standard triple therapy among those who will be tested positive using a cluster randomized control trial |
| Study Methods | This is a cross-sectional study followed by a cluster randomized control trial. The study will be conducted in two phases. The first phase consists of screening all eligible population between the age of 18 – 75 years. Following that, the positive cases will be provided with triple therapy treatment for 14 days and will be enrolled into the prospective CRT adherence study. The study sites will be the unit of randomization, and the tool of intervention is a mobile application that can be installed in an aneroid phone, tablet or iphone and participants can use to set up medication timing, record medication and its side effects. The control group receives identical treatment and health education using the standard care using paper-based prescription and verbal advice. After completing the 14-day therapy, participants will wait for a 30-day washout period. The second phase of study will screen the individuals post eradication to evaluate the efficacy of the therapy as well as to evaluate the effectiveness of the mobile application. The primary outcome of this study is to record H. pylori infection and the eradication rate, the secondary outcome is to record the antimicrobial adherence rate and to estimate the prevalence of antimicrobial resistance |
| Expected outcomes and use of results | - The primary outcome of this study is to measure the current prevalence of H. pylori infection and to measure the eradication rate after the standard triple therapy treatment. - The secondary outcomes are; (a) adherence to therapy by the participants as follows: o Valid - if they complete the medication in time (Adherence to specified timing) o Completed – (if they complete the medicine but forgot to mark in the application – intervention group, self-report by participants if they complete medication irrespective of adhering to specified timing) o Expire – if participants discontinue medications (record the reasons for not completing the medication – for intervention group it can be retrieve from the mobile application and for control group, interview the participants during the second screening) o (b) to record side effect of the drugs o (e) to record the types of side effects experienced by the participants Adherence outcome: we adapted the definition of adherence from Lefebvre et al. In our study adherence is defined as follows: a) perfect adherence if participants reports taking 100% (valid + complete) of the therapy (participants completes all drugs by day 14), and b) |
| Keywords | Helicobacter pylori, antimicrobials, adherance, antibiotics, Immunochromatography, stool antigen |
Research Details
| Student research | Yes |
| Institution: Poia University | |
| Academic degree: Ph.D. | |
| Supervisor of the student(s) | |
| Full Name and title: Yoshio Yamaoka | |
| Email: yyamaoka@oita-u.ac.jp | |
| Start Date | 04-Nov-2024 |
| End Date | 31-Jan-2025 |
| Key Implementing Institution | Self |
| Multi-country research | No |
| Nationwide research | Yes, with randomly selected geographical areas |
| Bhutan | |
| Research Domain(s) | Non-communicable diseases & Healthy Lifestyles |
| Research field(s) | Other (stomach cancer) |
| Involves human subjects | Yes |
| Population-Based Survey | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Approved |