NCT04525664

Assessment and Management of Chronic Dyspepsia in Eastern Uganda

Helicobacter Pylori and Chronic Dyspepsia in Eastern Uganda

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

This will be a prospective, controlled study that will be conducted in the Namutumba district. This district was selected because in a preliminary study, the prevalence of dyspeptic symptoms in this district was found to be 57%. Namutumba District has a population of slightly over 210,000 people. The prevalence of chronic dyspepsia and their associated symptoms will be determined using a questionnaire administered to all willing participants. All participants, regardless of symptoms, will also be offered fecal Hp antigen testing. Participants found to be infected with Hp will be given a 14-day course of antibiotics, per the current Ugandan standards of care, and assessed one month following completion of treatment. Participants with chronic dyspepsia who are negative for Hp will be given daily omeprazole for one month, and their symptoms will be assessed after one month.

Conditions

• Helicobacter Pylori Infection
• Dyspepsia

Interventions

Type	Name	Description
DRUG	Clarithromycin 500mg	500 mg per os twice daily for 14 consecutive days.
DRUG	Amoxicillin 1000 MG	1000 mg per os twice daily for 14 consecutive days.
DRUG	Omeprazole 40 MG	40 mg per os twice daily for 14 consecutive days.
DRUG	Omeprazole 20 MG Oral Tablet	20 mg per os daily for 1 month; only for patients with chronic dyspepsia and who are negative for Helicobacter pylori.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-05-31
• Completion: 2020-06-30
• First posted: 2020-08-25
• Last updated: 2020-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study