Assessment and Management of Chronic Dyspepsia in Eastern Uganda

NCT04525664 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 201807047
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

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).

Conditions

Helicobacter Pylori Infection; Dyspepsia

Keywords

helicobacter pylori; dyspepsia; prevalence

Outcome Measures

Primary Outcomes (2)

• Eradication of Helicobacter pylori among Helicobacter pylori positive participants as assessed by negative fecal antigen testing at the end of the treatment regimen

  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.

  4-6 weeks.

• Number of total participants at the beginning of the study who are positive for Helicobacter pylori, as assessed by fecal antigen testing

  The prevalence of Helicobacter pylori within the study population will be determined by conducting fecal antigen testing in participants providing informed consent.

  7 months

Secondary Outcomes (2)

• Correlation between dyspeptic symptoms from dyspepsia questionnaire and positivity for Helicobacter pylori based on fecal antigen testing

  7 months

• Efficacy of omeprazole for treating dyspepsia in Helicobacter pylori-negative participants.

  7 months

Other Outcomes (1)

• Safety and tolerability of treatment regimen for Helicobacter pylori.

  7 months

Study Arms (2)

Participants who test positive for Helicobacter pylori

EXPERIMENTAL

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.

Drug: Clarithromycin 500mg; Drug: Amoxicillin 1000 MG; Drug: Omeprazole 40 MG

Patients with dyspepsia and negative for Helicobacter pylori

EXPERIMENTAL

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.

Drug: Omeprazole 20 MG Oral Tablet

Interventions

Clarithromycin 500mg DRUG

500 mg per os twice daily for 14 consecutive days.

Participants who test positive for Helicobacter pylori

Amoxicillin 1000 MG DRUG

1000 mg per os twice daily for 14 consecutive days.

Participants who test positive for Helicobacter pylori

Omeprazole 40 MG DRUG

40 mg per os twice daily for 14 consecutive days.

Participants who test positive for Helicobacter pylori

Omeprazole 20 MG Oral Tablet DRUG

20 mg per os daily for 1 month; only for patients with chronic dyspepsia and who are negative for Helicobacter pylori.

Patients with dyspepsia and negative for Helicobacter pylori

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must be 18 years or older.
• All participants must provide informed consent.
• All participants receiving medications must be able to swallow pills.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Clarithromycin; Amoxicillin; Omeprazole; Tablets

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jose B Saenz, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 25, 2020
• Study Start: October 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: June 30, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)