Helicobacter Pylori Eradication and Irritable Bowel Syndr... | NCT04512898

Studies
Helicobacter Pylori Eradication and Irritable Bowel Syndrome: A Prospective Study

NCT04512898

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 14, 2020Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Irritable Bowel Syndrome

Interventions

Triple therapy for H.pylori

Countries

Not provided

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2020Estimated

Primary Completion Date

Nov 10, 2020Estimated

Completion Date

Nov 10, 2020Estimated

First Submitted Date

Aug 3, 2020

First Submission Date that Met QC Criteria

Aug 11, 2020

First Posted Date

Aug 14, 2020Actual

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

Aug 11, 2020

Last Update Posted Date

Aug 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haidi Karam, Lecturer of Tropical Medicine and Gastroenterology, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut 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

H. Pylori is frequently observed in patients with irritable bowel syndrome(IBS). However, the effect of H. pylori eradication on IBS is not clear.

Detailed Description

Patients with IBS symptoms using Rome IV criteria will be included. Testing for H. pylori will be done. Patients with H. pylori will receive triple therapy and followed after two weeks for eradication and assessment of IBS symptoms.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with IBS	Experimental	Patients with IBS and positive H. pylori.	Drug: Triple therapy for H.pylori

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Triple therapy for H.pylori	Drug	Triple therapy of proton pump inhibitors, clarithromycin and metronidazole.	Patient with IBS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Questionnaire for Rome IV criteria	Symptoms of IBS	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of life questionnaire	Quality of life.	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients newly diagnosed with IBS and H.pylori

Exclusion Criteria:

Patients received previous treatment of H.pylori
Patients receiving treatment for IBS.

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided