Assessment and Management of Chronic Dyspepsia in Eastern Uganda

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Helicobacter Pylori Infection; Dyspepsia

Treatments: Drug: Amoxicillin 1000 MG; Drug: Clarithromycin 500mg; Drug: Omeprazole 40 MG; Drug: Omeprazole 20 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04525664

201807047

Details and patient eligibility

About

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).

Full 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.

Enrollment: 376 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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376 participants in 2 patient groups

Participants who test positive for Helicobacter pylori

Experimental group

Description:

Participants who test positive for Helicobacter pylori by fecal antigen testing will be offered treatment with triple therapy (clarithromycin 500 mg per os twice daily, amoxicillin 1 g per os twice daily, omeprazole 40 mg per os twice daily) for 14 consecutive days. Two to four weeks following the completion of treatment, participants will repeat fecal antigen testing to confirm whether they eradicated the Helicobacter pylori.

Treatment:

Drug: Amoxicillin 1000 MG

Drug: Clarithromycin 500mg

Drug: Omeprazole 40 MG

Patients with dyspepsia and negative for Helicobacter pylori

Experimental group

Description:

Participants who report chronic dyspepsia but are negative for Helicobacter pylori by fecal antigen testing will receive daily omeprazole (20 mg per os) for one month. Their symptoms will be reassessed after completion of the month treatment.

Treatment:

Drug: Omeprazole 20 MG Oral Tablet