Assessment and Management of Chronic Dyspepsia in Eastern Uganda

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Chronic dyspepsia, or a sensation of indigestion, remains an underdiagnosed and often inappropriately managed cause of morbidity in countries with limited medical resources. A recent questionnaire of Eastern Ugandan residents identified chronic dyspepsia as the most bothersome symptom in nearly 60% of respondents, resulting in significant morbidity and work days missed. One of the most common causes for chronic dyspepsia worldwide is infection with the stomach-adapted bacterium Helicobacter pylori (Hp), the most significant risk factor for the development of stomach cancer. In developing countries, particularly in sub-Saharan Africa, the prevalence of Hp has not been accurately determined, often owing to a lack of adequate diagnostic methods. More importantly, proper diagnosis and treatment of chronic dyspepsia would limit morbidity and mortality and help decrease the likelihood of progressing to stomach cancer.

The purposes of this study are to identify the prevalence of chronic dyspepsia among residents of eastern Uganda using a questionnaire, to assess how common Hp infection is using fecal Hp antigen test kits, and to evaluate the efficacy of Hp eradication using standard Ugandan treatment guidelines. Participants who test positive for Hp infection by fecal Hp antigen testing will be offered Hp eradication treatment in the form of two antibiotics (clarithromycin, amoxicillin) and an acid-suppression medication (omeprazole), according to the current Ugandan guidelines. Patients with chronic dyspepsia who are negative for Hp (by fecal antigen testing) will be given a one-month trial of omeprazole alone, according to current American College of Gastroenterology guidelines, and their symptoms will be reassessed. At the end of the treatment regimens, participants will have the option to complete a follow-up questionnaire and provide stool samples for fecal antigen testing (if they were Hp-positive).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Amoxicillin; Clarithromycin; Omeprazole

Criteria

Inclusion Criteria:

• All participants must be 18 years or older.

• All participants must provide informed consent.

• All participants receiving medications must be able to swallow pills.

Exclusion Criteria:

• A participant's inability to understand the questions or informed consent form, either in Lusoga (the regional dialect) or English (the official language of Uganda), as determined by the study team member administering the questionnaire/informed consent.

• Age less than 18 years old.

• Participants who have used any antibiotic(s) within the past 30 days.

• Participants who have used any proton pump inhibitors within the past 30 days.