Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children

Sponsor

Finni Kollins (Other)

Overall Status

Completed

CT.gov ID

NCT05861687

Collaborator

(none)

Enrollment

Locations

Arms

9.6

Actual Duration (Months)

25.5

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to compare the recurrence rates of Esomeprazole and Lansoprazole in triple combination therapy to eradicate H.pylori infection in children. The participants were divided into two groups, those who received Esomeprazole and those who received Lansoprazole

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Esomeprazole Drug: Lansoprazole Drug: Amoxicillin Drug: Clarithromycin	Phase 2/Phase 3

Detailed Description

pylori eradication therapy is still contentious. A treatment that is uncomplicated, well-tolerated, and boasts an efficiency rate of more than 80% is recommended.

PPIs are a type of acid-sensitive drug which is most beneficial in preventing the degradation of drugs in the stomach. In developing countries, Esomeprazole and Lansoprazole were mainly selected as a drug of choice. Major influential factors such as Esomeprazole's additional antioxidant ability, are comparable to vitamin C. This is due to its ability to scavenge Diphenyl Picrylhydrazyl (DPPH) free radicals at low concentrations. Lansoprazole also possess similar ability, albeit needs a slightly higher concentration to reach a similar effect. In terms of IC50 values, both drugs have a substantial advantage over vitamin C, earning them the title of 'potentially ideal' agents in the treatment algorithm. Furthermore, numerous studies mention that children better tolerate PPIs.

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparative Recurrence Rate Investigation of Esomeprazole Versus Lansoprazole in Triple-Combination Therapy to Eradicate Helicobacter Pylori Infection Among Pediatrics: Multicentre, Randomized, and Controlled Trials

Actual Study Start Date :

Aug 1, 2021

Actual Primary Completion Date :

Dec 7, 2021

Actual Study Completion Date :

May 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Esomeprazole in combination with Amoxicillin and Clarithromycin Esomeprazole : once a day per oral; 0.4 mg/kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg	Drug: Esomeprazole Administered once a day per-oral (PO) with the dose of 0.4 mg/kg Drug: Amoxicillin Administered thrice a day per-oral (PO) with the dose of 25 mg/kg Drug: Clarithromycin Administered twice a day per-oral with the dose of 7.5 mg/kg
Active Comparator: Lansoprazole in combination with Amoxicillin and Clarithromycin Lansoprazole: once a day per oral; 15 mg if body weight < 30 kg and 30 mg if body weight > 30 kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg	Drug: Lansoprazole Administered once a day per-oral (PO) with the dose of 15 mg if individual's body mass was <30 kg, and 30 mg if it was >30 kg Drug: Amoxicillin Administered thrice a day per-oral (PO) with the dose of 25 mg/kg Drug: Clarithromycin Administered twice a day per-oral with the dose of 7.5 mg/kg

Arm

Intervention/Treatment

Experimental: Esomeprazole in combination with Amoxicillin and Clarithromycin

Esomeprazole : once a day per oral; 0.4 mg/kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg

Drug: Esomeprazole

Administered once a day per-oral (PO) with the dose of 0.4 mg/kg

Drug: Amoxicillin

Administered thrice a day per-oral (PO) with the dose of 25 mg/kg

Drug: Clarithromycin

Administered twice a day per-oral with the dose of 7.5 mg/kg

Active Comparator: Lansoprazole in combination with Amoxicillin and Clarithromycin

Lansoprazole: once a day per oral; 15 mg if body weight < 30 kg and 30 mg if body weight > 30 kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg

Drug: Lansoprazole

Administered once a day per-oral (PO) with the dose of 15 mg if individual's body mass was <30 kg, and 30 mg if it was >30 kg

Drug: Amoxicillin

Administered thrice a day per-oral (PO) with the dose of 25 mg/kg

Drug: Clarithromycin

Administered twice a day per-oral with the dose of 7.5 mg/kg

Outcome Measures

Primary Outcome Measures

Helicobacter pylori Stool Antigen Test [15 days]
The stool of the subjects will be assessed on day-15 after drug administration. A negative result indicates that patient is infection-free

Secondary Outcome Measures

Helicobacter pylori Stool Antigen Test [75 days]
The stool of the subjects will be analyzed on day-90 after drug administration to assess whether a reinfection is present. A negative result indicates that patient is infection-free

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject has positive clinical symptoms (gastrointestinal pain, nausea, vomiting, hematemesis, or melena)
Subject had been diagnosed with H.pylori infection prior to endoscopy and rapid urease testing

Exclusion Criteria:

subject has a history of using antibiotics or non-steroidal anti-inflammatory medicines (NSAIDs) within 14 days prior to surgery
subject has a concomitant systemic disease (e.g., renal failure, liver cirrhosis, cancer, etc.) that could theoretically affect the subject's response to treatment
Incomplete triple pharmacologic treatment due to the subject's lack of medication adherence