the Relationship Between Helicobacter Pylori Infection an... | NCT04847401

Studies
the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome

NCT04847401

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Apr 19, 2021Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Irritable Bowel Syndrome

Interventions

H. pylori stool antigen

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

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

May 25, 2021Estimated

Primary Completion Date

Nov 1, 2021Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Apr 12, 2021

First Submission Date that Met QC Criteria

Apr 14, 2021

First Posted Date

Apr 19, 2021Actual

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

Apr 14, 2021

Last Update Posted Date

Apr 19, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Evaluating any possible relationship between irritable bowel syndrome occurrence and Helicobacter pylori infection

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		patients with Irritable Bowel Syndrome	Diagnostic Test: H. pylori stool antigen
Group 2		normal	Diagnostic Test: H. pylori stool antigen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
H. pylori stool antigen	Diagnostic Test	using H. pylori antigen kits in stool	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of irritable bowel syndrome patients who had H.pylori infection	H.pylori stool antigen kits	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients will be selected according to Rome IV criteria for the diagnosis of IBS, which include:

Recurrent abdominal pain at least 1 day/week in the last 3 months, with two or more of the following criteria:

Related to defecation
Associated with a change in frequency of stool
Associated with a change in form of stool. Criteria achieved for the last 3 months with symptom onset at least 6 months before diagnosis

Exclusion Criteria:

• Rectal bleeding
- Anemia
- Weight loss
- Onset after 50 years of age
- Recent antibiotic use
- Abnormal abdominal examination (organomegaly, lump)
- Family history of colorectal cancer.
- Family history of inflammatory bowel disease, or celiac disease.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

outpatient clinic patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reham Mohy Kamel, MBBCh	Contact	01274648573		reham.amin@med.sohag.edu.eg

Overall Officials

Not provided

Locations

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

Type	Date	Date Unknown
Release	May 31, 2022
Reset	Mar 3, 2023

Submission Tracking

Estimated Results First Submitted Date

May 31, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 31, 2022			Mar 3, 2023

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