NCT03102411

Brief Summary

This cross-sectional survey study is to determine the prevalence of functional gastrointestinal (GI) disorders in the general population and to describe common triggers for food-related GI symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,881

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 9, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 18, 2019

Completed
Last Updated

January 25, 2019

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

March 14, 2017

Results QC Date

May 14, 2018

Last Update Submit

January 23, 2019

Conditions

Gastrointestinal Disorder, Functional

Outcome Measures

Primary Outcomes (1)

  • Most Common Triggers for Food-related GI Symptoms (Top 5)

    Percentages for foods chosen as triggers ( a subject can check more than one answer - Bread, Oats, Chili, Corn, Onion, Garlic, Beans, Chocolate, Fried or greasy foods, Eggs, Soy, Red meat, Fish or shellfish, Dairy products, Nuts and seeds, Apples, Bananas, Citrus fruit, Alcohol, Coffee, Carbonated drinks, Sugar-free gum)

    During the past 3 months before the survey

Secondary Outcomes (1)

  • Self-reported Functional GI Disorders

    During the past 3 months before the survey

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General popultion in the United States

You may not qualify if:

  • Visual impairment
  • Inability to read
  • Inability to understand English
  • Inability to use a computer to respond to questions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

Title
Rachel Pauls MD
Organization
TriHealth Inc.
Rachel_Pauls@trihealth.com
513-463-4300

Study Officials

  • Rachel Pauls, MD

    TriHealth - Cincinnati Urogynecology Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2017

First Posted

April 5, 2017

Study Start

March 9, 2017

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

January 25, 2019

Results First Posted

January 18, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)