NCT04847401

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

April 12, 2021

Last Update Submit

April 14, 2021

Conditions

Keywords

Helicobacter PyloriIrritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • number of irritable bowel syndrome patients who had H.pylori infection

    H.pylori stool antigen kits

    through study completion, an average of 1 year

Study Arms (2)

Group 1

patients with Irritable Bowel Syndrome

Diagnostic Test: H. pylori stool antigen

Group 2

normal

Diagnostic Test: H. pylori stool antigen

Interventions

using H. pylori antigen kits in stool

Group 1Group 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

outpatient clinic patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Reham Mohy Kamel, MBBCh

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 19, 2021

Study Start

May 25, 2021

Primary Completion

November 1, 2021

Study Completion

January 1, 2022

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share