NCT04512898

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.

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
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_4

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

August 3, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 3, 2020

Last Update Submit

August 11, 2020

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Questionnaire for Rome IV criteria

    Symptoms of IBS

    2 weeks

Secondary Outcomes (1)

  • Quality of life questionnaire

    2 weeks

Study Arms (1)

Patient with IBS

EXPERIMENTAL

Patients with IBS and positive H. pylori.

Drug: Triple therapy for H.pylori

Interventions

Triple therapy for H.pyloriDRUG

Triple therapy of proton pump inhibitors, clarithromycin and metronidazole.

Patient with IBS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients newly diagnosed with IBS and H.pylori

You may not qualify if:

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

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients with IBS and have H. pylori
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical Medicine and Gastroenterology

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 14, 2020

Study Start

August 10, 2020

Primary Completion

November 10, 2020

Study Completion

November 10, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share