Assessment and Management of Chronic Dyspepsia in Eastern Uganda

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).

Conditions

• Helicobacter Pylori Infection
• Dyspepsia

Interventions

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.

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Jose B Saenz, MD, PhD · Washington University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-01

Primary Completion

2019-05-31

Completion

2020-06-30

FDA Drug

Yes

Countries

• United States

Study Locations