H Pylori GastritisCETRNCT04721704
Comparison of Efficacy of Triple Regimen Based on Clarithromycin VS Metronidazole in Children
A study testing Clarithromycin+ Amoxicillin + Omeprazole and Metronidazole +Amoxicillin + Omeprazole in people with H Pylori Gastritis, run by Shaheed Zulfiqar Ali Bhutto Medical University at 2 sites in Pakistan.
Trial summary
All children from 1day to 18years of age, diagnosed with peptic ulcer disease due to H pylori at Pakistan Institute of Medical Sciences, Islamabad, from July 2020 to December 2021 will be included in the study. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- H Pylori Gastritis
- What is being tested?
- Clarithromycin+ Amoxicillin + Omeprazole and Metronidazole +Amoxicillin + Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesPakistan
- Study dates
- 14 Sep 2020to 14 Sep 2022
- Phase
- Interventional
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. All children age 1-12 years having H-pylori gastritis
Who cannot join
- drug induced gastritis critically ill child
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Pakistan Institute of Medical Sciences,SZABMU
Islamabad, Capital Territory, 44000
Nadia W,aheed, FCPS, 923334461116, drnadiasalman@gmail.com
Nighat Haider, FCPS, 923212125768, nighathaider@hotmail.com
- Recruiting
Pakistan Institute of Medical Sciences, Islamabad
Islamabad, Islamabad, 44000
Nadia W,aheed, FCPS, 923334461116, drnadiasalman@gmail.com
Nighat Haider, FCPS, 923212125768, nighathaider@hotmail.com
About this study
Official title: Comparison of Efficacy and Safety of Triple Regimen Based on Clarithromycin VS Metronidazole in Pediatric Population in Pakistan
All children from 1day to 18years of age, diagnosed with peptic ulcer disease due to H pylori at Pakistan Institute of Medical Sciences, Islamabad, from July 2020 to December 2021 will be included in the study. After informed written consent from parents/ guardians patients' bio data along with history and examination will be recorded on a proforma. They will be allocated into two groups, group A and group B randomly based on treatment regimen offered.
Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI) Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI The history will include presenting symptoms along duration, remission of symptoms after therapy and clinical outcome will also be recorded.
Read the detailed description
Helicobacter pylori is a gram-negative bacillus responsible for one of the most common infections found in humans worldwide1. In general, the prevalence is high in developing countries and the infection is acquired at a young age. Most children infected with H pylori are asymptomatic. Antral gastritis is the most common manifestation in children. Duodenal and gastric ulcers may be associated with H pylori gastritis in 1.8 % children2. Antibiotic resistance is the major cause of failure in the treatment of H pylori infection3. Most of the studies worldwide confirmed an increase in macrolide resistance, while metronidazole resistance either decreased or remained stable. In a prospective multicenter European study, primarily comprised of adults, found a 31.8% resistance rate to clarithromycin and 25.7% to metronidazole in the study4.
If the strain is resistant to one of the antibiotics used, treatment success will be compromised5. As a result therapies that are recommended should be based on antibiotic susceptibility testing. If this testing is not available, then clarithromycin-based triple therapy should not be used as part of first-line therapy due to high rates of clarithromycin resistance rates6 The European Society for Paeditric Gastroenterology Hepatology and Nutrition/North American Society for Pediatric Gastroenterology, Hepatology and Nutrition made the recommendations in 2017 for the Management of Helicobacter pylori in Children that antimicrobial sensitivity should be obtained for the infecting H pylori to tailor eradication therapy accordingly and the effectiveness of first-line therapy should be evaluated in national/regional centers7.
If the strain is susceptible to clarithromycin (CLA) and to metronidazole (MET), triple therapy (PPI, amoxicillin [AMO], CLA) for 14 days and doses of proton pump inhibitor and antibiotics should be calculated based on the bodyweight8.
We aim to study efficacy and safety of clarithromycin vs metronidazole based triple regimen for the eradication of H pylori in children with peptic ulcer disease.
- Conditions
- H Pylori Gastritis
- Being tested
- Clarithromycin+ Amoxicillin + Omeprazole, Metronidazole +Amoxicillin + Omeprazole
- Keywords
- H-pylori gastritis, eradication therapy, triple regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin+ Amoxicillin + OmeprazoleDrug
Also called Klaricid + Amoxil + Risek
In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children
Metronidazole +Amoxicillin + OmeprazoleDrug
Also called Flagyl + Amoxil + Risek
Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will be given Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI based triple regimen Receives: Drug: Clarithromycin+ Amoxicillin + Omeprazole |
| Group B | Experimental | Group B will be given Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI based triple regimen Receives: Drug: Metronidazole +Amoxicillin + Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Clarithromycin vs Metronidazole based triple regimen in treatment of H-pylori in induced Acid peptic disease in children in terms of reduction in duration of symptoms and negative Stool H-Pylori-Ag
All children age 1-12 years diagnosed with acid peptic disease with positive H-pylori Ag in stool will be randomized in to Group A \& Group B and will be given either CLA or MET based triple eradication regimen. After 4 weeks of complication of triple regimen patients form both groups will be re-tested for H-pylori Ag in stool. The efficacy of both regimen will be compare in terms of duration of resolution of symptoms of Acid peptic disease and number of patients having negative stool H pylori Ag post treatment.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start14 Sep 2020
- Primary completion14 Sep 2022 (estimated)
- Study completion14 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H Pylori GastritisStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Nadia waheed, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Nadia Waheed, Principal investigator, PIMS, SZABMU,ISLAMABAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721704
- Sponsor's protocol ID
- F-.1-1/2015/ERB/SZABMU/646
- Acronym
- CETR
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: SPSS DATA SHEETS WILL BE SHARED
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Triple Regimen Based on Clarithromycin VS Metronidazole in Pediatric Population in Pakistan
- ClinicalTrials.gov ID
- NCT04721704
- Acronym / sponsor ID
- CETR / F-.1-1/2015/ERB/SZABMU/646
- Conditions
- H Pylori Gastritis
- Keywords
- H-pylori gastritis, eradication therapy, triple regimen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 14 Sep 2022 (estimated)
- Study completion
- 14 Sep 2022 (estimated)
- First posted
- 25 Jan 2021 (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.
All children from 1day to 18years of age, diagnosed with peptic ulcer disease due to H pylori at Pakistan Institute of Medical Sciences, Islamabad, from July 2020 to December 2021 will be included in the study. After informed written consent from parents/ guardians patients' bio data along with history and examination will be recorded on a proforma. They will be allocated into two groups, group A and group B randomly based on treatment regimen offered.
Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI) Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI The history will include presenting symptoms along duration, remission of symptoms after therapy and clinical outcome will also be recorded.
Detailed description
Helicobacter pylori is a gram-negative bacillus responsible for one of the most common infections found in humans worldwide1. In general, the prevalence is high in developing countries and the infection is acquired at a young age. Most children infected with H pylori are asymptomatic. Antral gastritis is the most common manifestation in children. Duodenal and gastric ulcers may be associated with H pylori gastritis in 1.8 % children2. Antibiotic resistance is the major cause of failure in the treatment of H pylori infection3. Most of the studies worldwide confirmed an increase in macrolide resistance, while metronidazole resistance either decreased or remained stable. In a prospective multicenter European study, primarily comprised of adults, found a 31.8% resistance rate to clarithromycin and 25.7% to metronidazole in the study4.
If the strain is resistant to one of the antibiotics used, treatment success will be compromised5. As a result therapies that are recommended should be based on antibiotic susceptibility testing. If this testing is not available, then clarithromycin-based triple therapy should not be used as part of first-line therapy due to high rates of clarithromycin resistance rates6 The European Society for Paeditric Gastroenterology Hepatology and Nutrition/North American Society for Pediatric Gastroenterology, Hepatology and Nutrition made the recommendations in 2017 for the Management of Helicobacter pylori in Children that antimicrobial sensitivity should be obtained for the infecting H pylori to tailor eradication therapy accordingly and the effectiveness of first-line therapy should be evaluated in national/regional centers7.
If the strain is susceptible to clarithromycin (CLA) and to metronidazole (MET), triple therapy (PPI, amoxicillin [AMO], CLA) for 14 days and doses of proton pump inhibitor and antibiotics should be calculated based on the bodyweight8.
We aim to study efficacy and safety of clarithromycin vs metronidazole based triple regimen for the eradication of H pylori in children with peptic ulcer disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Clarithromycin+ Amoxicillin + OmeprazoleGroup A will be given Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI based triple regimen |
| Group B | Experimental | Drug: Metronidazole +Amoxicillin + OmeprazoleGroup B will be given Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI based triple regimen |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. All children age 1-12 years having H-pylori gastritis
Key exclusion criteria (1 listed)
- drug induced gastritis critically ill child
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+ Amoxicillin + OmeprazoleAlso: Klaricid + Amoxil + RisekIn Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children | Drug | Group A |
| Metronidazole +Amoxicillin + OmeprazoleAlso: Flagyl + Amoxil + RisekGroup B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI | Drug | Group B |
Primary outcome
Efficacy of Clarithromycin vs Metronidazole based triple regimen in treatment of H-pylori in induced Acid peptic disease in children in terms of reduction in duration of symptoms and negative Stool H-Pylori-Ag
Time frame: 2 weeks
All children age 1-12 years diagnosed with acid peptic disease with positive H-pylori Ag in stool will be randomized in to Group A \& Group B and will be given either CLA or MET based triple eradication regimen. After 4 weeks of complication of triple regimen patients form both groups will be re-tested for H-pylori Ag in stool. The efficacy of both regimen will be compare in terms of duration of resolution of symptoms of Acid peptic disease and number of patients having negative stool H pylori Ag post treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: Yes. SPSS DATA SHEETS WILL BE SHARED
Related trials for H Pylori Gastritis
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingObservational study
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Helicobacter Pylori, Atrophic Gastritis
Not yet recruitingObservational study
NLR and PLR in H. Pylori-Associated Gastritis
Helicobacter Pylori Infection, Gastritis
RecruitingObservational study
The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies
Functional Dyspepsia, Gastritis
RecruitingObservational study
A Prospective Cohort Study on Endoscopic Features of Upper Gastrointestinal Tract at High Altitude (Zaduo County)
Reflux Esophagitis
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.
Nadia Waheed principal investigator
PIMS, SZABMU,ISLAMABAD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clarithromycin+ Amoxicillin + Omeprazole and Metronidazole +Amoxicillin + Omeprazole in people with H Pylori Gastritis, run by Shaheed Zulfiqar Ali Bhutto Medical University at 2 sites in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Waheed (923334461116, drnadiasalman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Clarithromycin vs Metronidazole based triple regimen in treatment of H-pylori in induced Acid peptic disease in children in terms of reduction in duration of symptoms and negative Stool H-Pylori-Ag (time frame: 2 weeks). 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 26 Jan 2021.