Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT04525664
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).
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
St Louis, Missouri, 63110, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
500 mg per os twice daily for 14 consecutive days.
1000 mg per os twice daily for 14 consecutive days.
40 mg per os twice daily for 14 consecutive days.
20 mg per os daily for 1 month; only for patients with chronic dyspepsia and who are negative for Helicobacter pylori.
Time frame: 4-6 weeks.
Participants who initially test positive for Helicobacter pylori by fecal antigen testing will receive treatment for 14 consecutive days. Two to four weeks following treatment completion, participants will repeat fecal antigen testing to confirm eradication of Helicobacter pylori. The primary outcome measure will be the percentage of participants who initially tested positive for Helicobacter pylori and were found to be negative at the end of the treatment regimen.
Time frame: 7 months
The prevalence of Helicobacter pylori within the study population will be determined by conducting fecal antigen testing in participants providing informed consent.
Time frame: 7 months
Based on a validated dyspepsia questionnaire, we will correlate the prevalence and severity of chronic dyspepsia with Helicobacter pylori status (determined by fecal antigen testing).
Time frame: 7 months
We will assess the efficacy of empiric omeprazole treatment in participants with chronic dyspepsia who are negative for Helicobacter pylori by fecal antigen testing. Efficacy of treatment will be determined by a comparison of dyspepsia scores before and after treatment, as assessed by the validated dyspepsia questionnaire.
Time frame: 7 months
Participants who are provided treatment for Helicobacter pylori will meet with study coordinators 3-5 times during the treatment regimen to assess tolerability and to report any side effects or adverse reactions to the medications. Any adverse reactions will be immediately reported to the study coordinator.
Washington University School of Medicine
Other
Helicobacter Pylori and Chronic Dyspepsia in Eastern Uganda
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