NCT04759378

Brief Summary

assess the incidence of the entire spectrum of esophageal disorders and possible theories for overlap in IBS patients using different diagnostic modalities.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

January 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

January 12, 2021

Last Update Submit

February 13, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of GERD in IBS patients who have upper GIT symptoms

    use the result of the comprehensive examination, upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.

    baseline

  • Incidence of Functional esophageal disorders in IBS patient who have upper GIT symptoms.

    use the result of the comprehensive examination, including upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.

    baseline

Study Arms (1)

IBS patients who have upper GIT symptoms

EXPERIMENTAL
Diagnostic Test: Upper endoscopy, esophageal manometry, 24-hour pH monitoring

Interventions

upper endoscopy determines if there are structural abnormalities in upper Git. esophageal manometry determines if there are motility disorders. 24-hour pH monitoring determines if acid reflux is present or not, and specifies its rate and duration.

IBS patients who have upper GIT symptoms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established diagnosis of IBS (according to the Rome criteria of the III revision).
  • Upper GIT symptoms in the form of heartburn (sometimes belching), a lump in the throat, and non-cardiac chest pain.

You may not qualify if:

  • History of thoracic, esophageal, or gastric surgery.
  • Presence of duodenal or gastric ulcer on upper endoscopy.
  • Presence of duodenal or gastric cancer on upper endoscopy.
  • Conditions that prevent the installation of a nasogastric tube (nasopharyngeal formation, severe lumen-facial trauma).
  • mental disorders state and disability.
  • Pregnancy and breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal RefluxNon-Erosive Reflux DiseaseIrritable Bowel Syndrome

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

bishoy s shehata, doctor

CONTACT

hossam m Abdelwahaab, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Assiut Univeristy Hospotal

Study Record Dates

First Submitted

January 12, 2021

First Posted

February 18, 2021

Study Start

February 25, 2021

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

February 18, 2021

Record last verified: 2021-02