Helicobacter Pylori InfectionEarly Phase 1NCT04525664
Assessment and Management of Chronic Dyspepsia in Eastern Uganda
A Early Phase 1 study testing Clarithromycin 500mg, Amoxicillin 1000 MG and Omeprazole 40 MG in people with Helicobacter Pylori Infection and Dyspepsia, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Dyspepsia
- What is being tested?
- Clarithromycin 500mg, Amoxicillin 1000 MG and Omeprazole 40 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Jun 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants must be 18 years or older.
- All participants must provide informed consent.
- All participants receiving medications must be able to swallow pills.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Helicobacter Pylori and Chronic Dyspepsia in Eastern Uganda
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).
Read the 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.
- Conditions
- Helicobacter Pylori Infection, Dyspepsia
- Being tested
- Clarithromycin 500mg, Amoxicillin 1000 MG, Omeprazole 40 MG, Omeprazole 20 MG Oral Tablet
- Keywords
- helicobacter pylori, dyspepsia, prevalence
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin 500mgDrug
500 mg per os twice daily for 14 consecutive days.
Amoxicillin 1000 MGDrug
1000 mg per os twice daily for 14 consecutive days.
Omeprazole 40 MGDrug
40 mg per os twice daily for 14 consecutive days.
Omeprazole 20 MG Oral TabletDrug
20 mg per os daily for 1 month; only for patients with chronic dyspepsia and who are negative for Helicobacter pylori.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Omeprazole 20 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 months
Secondary outcomes (2)
Correlation between dyspeptic symptoms from dyspepsia questionnaire and positivity for Helicobacter pylori based on fecal antigen testing
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).
Measured: 7 months
Efficacy of omeprazole for treating dyspepsia in Helicobacter pylori-negative participants.
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Oct 2018
- Primary completion31 May 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Saenz, Washington University School of Medicine
- Investigators
- Jose B Saenz, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525664
- Sponsor's protocol ID
- 201807047
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data related to the study protocol, statistical analysis plan, and informed consent will be shared with other researchers if and when it is requested from the study's Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori and Chronic Dyspepsia in Eastern Uganda
- ClinicalTrials.gov ID
- NCT04525664
- Acronym / sponsor ID
- 201807047
- Conditions
- Helicobacter Pylori Infection, Dyspepsia
- Keywords
- helicobacter pylori, dyspepsia, prevalence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants who test positive for Helicobacter pylori | Experimental | Drug: Clarithromycin 500mg, Drug: Amoxicillin 1000 MG, Drug: Omeprazole 40 MGParticipants 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. |
| Patients with dyspepsia and negative for Helicobacter pylori | Experimental | Drug: Omeprazole 20 MG Oral TabletParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All participants must be 18 years or older.
- All participants must provide informed consent.
- All participants receiving medications must be able to swallow pills.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clarithromycin 500mg500 mg per os twice daily for 14 consecutive days. | Drug | Participants who test positive for Helicobacter pylori |
| Amoxicillin 1000 MG1000 mg per os twice daily for 14 consecutive days. | Drug | Participants who test positive for Helicobacter pylori |
| Omeprazole 40 MG40 mg per os twice daily for 14 consecutive days. | Drug | Participants who test positive for Helicobacter pylori |
| Omeprazole 20 MG Oral Tablet20 mg per os daily for 1 month; only for patients with chronic dyspepsia and who are negative for Helicobacter pylori. | Drug | Patients with dyspepsia and negative for Helicobacter pylori |
Primary outcome
Eradication of Helicobacter pylori among Helicobacter pylori positive participants as assessed by negative fecal antigen testing at the end of the treatment regimen
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.
Number of total participants at the beginning of the study who are positive for Helicobacter pylori, as assessed by fecal antigen testing
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.
2 secondary outcomes
Correlation between dyspeptic symptoms from dyspepsia questionnaire and positivity for Helicobacter pylori based on fecal antigen testing
Time frame: 7 months
Efficacy of omeprazole for treating dyspepsia in Helicobacter pylori-negative participants.
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: Yes. Data related to the study protocol, statistical analysis plan, and informed consent will be shared with other researchers if and when it is requested from the study's Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose B Saenz, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Clarithromycin 500mg, Amoxicillin 1000 MG and Omeprazole 40 MG in people with Helicobacter Pylori Infection and Dyspepsia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of Helicobacter pylori among Helicobacter pylori positive participants as assessed by negative fecal antigen testing at the end of the treatment regimen (time frame: 4-6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.