A Comparative Study Between Concomitant Versus Load Thera... | NCT06050824

Studies
A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection

NCT06050824

Sponsor

Helwan University

Status

Completed

Last Update Posted

Sep 26, 2023Actual

Enrollment

200Actual

Phase

Phase 4

Conditions

H. Pylori Infection

Interventions

Comparing Load and Concomitant therapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2022Actual

Primary Completion Date

Jul 19, 2023Actual

Completion Date

Jul 19, 2023Actual

First Submitted Date

Sep 16, 2023

First Submission Date that Met QC Criteria

Sep 16, 2023

First Posted Date

Sep 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2023

Last Update Posted Date

Sep 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hala Hany Shehata, Principle Investigator, Helwan UniversityPrincipal Investigator

Lead Sponsor

Helwan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies.

The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.

About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.

All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.

Biopsies will be classified using the Updated Sydney system of classification of gastritis

Detailed Description

The patients will be randomized (closed envelopes) into one of two groups:

patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.
patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.

H. Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
concomitant	Active Comparator	Clarithro -pantoprazole- Metronidazole - Amoxicyllin	Drug: Comparing Load and Concomitant therapy
LOAD	Active Comparator	Levofloxacin -omeprazole- nitazoxanide- Doxycycline	Drug: Comparing Load and Concomitant therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparing Load and Concomitant therapy	Drug	Levofloxacin - Omeprazole - nitazoxanide - doxycycline	LOAD concomitant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eradication of H. pylori infection after treatment	Negative stool antigen test for H.pylori	4 weeks after end of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who presented with epigastric pain and dyspeptic symptoms

Exclusion Criteria:

Patients recently (within 6 months) treated with anti-H. pylori therapy.
Allergy to any drugs used in our protocol
Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.
Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).
Presence of GI malignancy.
Pregnancy or lactating women.
Unable or refuse to give consent. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Helwan University		Cairo		11795	Egypt