Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04525664
Status:
COMPLETED
Last Update Posted:
2020-08-25
First Post:
2020-08-18
Brief Title:
Assessment and Management of Chronic Dyspepsia in Eastern Uganda
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Helicobacter Pylori and Chronic Dyspepsia in Eastern Uganda
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 210000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None