Clinical trial NCT04525664: Assessment and Management of Chronic Dyspepsia in Eastern Uganda
Official title: Helicobacter Pylori and Chronic Dyspepsia in Eastern Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Helicobacter Pylori Infection
Dyspepsia
Keywords: helicobacter pylori
dyspepsia
prevalence
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will use the lot quality assurance sampling (LQAS) method. Households will be selected through random sampling, and each household will be asked for a list of all people over eighteen years old. Then, a person in the household will be selected using random sampling methods and be asked if they wish to participate in the study. Willing participants will provide informed consent and will be given a questionnaire to identify common symptoms of dyspepsia . All participants who complete the questionnaire will also provide a stool specimen (if willing) for fecal antigen testing. Participants who underwent Hp eradication therapy or empiric omeprazole treatment will also be given the opportunity to complete a follow-up questionnaire following completion of their treatment regimen.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eradication of Helicobacter pylori among Helicobacter pylori positive participants as assessed by negative fecal antigen testing at the end of the treatment regimen
timeFrame: 4-6 weeks.
measure: Number of total participants at the beginning of the study who are positive for Helicobacter pylori, as assessed by fecal antigen testing
timeFrame: 7 months
Secondary outcomes:
measure: Correlation between dyspeptic symptoms from dyspepsia questionnaire and positivity for Helicobacter pylori based on fecal antigen testing
timeFrame: 7 months
measure: Efficacy of omeprazole for treating dyspepsia in Helicobacter pylori-negative participants.
timeFrame: 7 months
Other outcomes:
measure: Safety and tolerability of treatment regimen for Helicobacter pylori.
timeFrame: 7 months
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jose B Saenz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: