Assessment and Management of Chronic Dyspepsia in Eastern Uganda - Trial NCT04525664

Timeline & Enrollment

Primary Outcome

Eradication of Helicobacter pylori among Helicobacter pylori positive participants as assessed by negative fecal antigen testing at the end of the treatment regimen,Number of total participants at the beginning of the study who are positive for Helicobacter pylori, as assessed by fecal antigen testing

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).

ICD-10 Classifications