NCT03102411

Completed

Impact of Diet on Functional Gastrointestinal Symptoms

TriHealth Inc.Source

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Other study identifiers

Sponsor study identifier

17-006

Study Type

observational

Actual enrollment (reported)

1,881

Locations

1 country

Sites

1

Timeline

Study Start

March 9, 2017

Actual (reported)

Primary Completion

September 15, 2017

Actual (reported)

Study Completion

September 15, 2017

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 1,881 participants
Study completion date: September 15, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 9, 2017
Actual (reported)
First Submitted
March 14, 2017
Actual (reported)
First Posted
April 5, 2017
Actual (reported)
Primary Completion
September 15, 2017
Actual (reported)
Study Completion
September 15, 2017
Actual (reported)
Results Posted
January 18, 2019
Actual (reported)

Last Updated: January 25, 2019
Status Verified: May 2018
Results QC Date: August 2, 2018
Last Update Submitted: 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

Sponsors & Collaborators

TriHealth Inc.
Otherlead

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

Title: Rachel Pauls MD
Organization: TriHealth Inc.

Study Officials

Rachel Pauls, MD
TriHealth - Cincinnati Urogynecology Associates
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

1,881 participants (actual enrollment reported by the registry).

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

Actual (reported)

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Inability to read

Inability to understand English

Inability to use a computer to respond to questions.

Contact the study team to confirm eligibility.

Primary Completion

September 15, 2017

Actual (reported)

Study Completion

September 15, 2017

Actual (reported)

Last Updated

January 25, 2019

Results First Posted

January 18, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03102411
Data provider: ClinicalTrials.gov
Source updated: 2019-01-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:19 UTC

Documents

Study Protocol and Statistical Analysis Plan
ProtocolSAP2017-03-01

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations