Impact of Diet on Functional Gastrointestinal Symptoms

Impact of Diet on Functional Gastrointestinal Symptoms; a National Population Based Survey

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Disorder, Functional

Detailed Description

Functional gastrointestinal disorders, involving symptoms such as gas/bloating, diarrhea, constipation and abdominal pain, are estimated to impact between 35 and 45 million Americans, an overwhelming 15-20% of the population. These symptoms are responsible for upwards of 20 billion dollars in healthcare costs and extensive loss of quality of life for sufferers. Moreover, many patients suffer in silence, with 67% of subjects waiting more than a year before treatment, and 11% waiting over 10 years. Irritable bowel syndrome is the most prevalent functional gastrointestinal disorder, and several recent studies support the idea that dietary modifications may be key to alleviating this condition.

The purpose of this study is to document gastrointestinal symptoms among the US population, as well as to ascertain awareness and utilization of dietary treatments that exist.

• Study Type: Observational
• Enrollment (Actual): 1881

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General popultion in the United States

Description

Inclusion Criteria:

-

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Functional GI Disorders	Percentages of self-reported functional GI disorders ( a subject can check more than one answer - Acid reflux (GERD), Irritable bowel syndrome (IBS), Celiac disease, Inflammatory bowel disease - Crohn's or Ulcerative Colitis, Diverticulities, Gastroparesis, Leaky gut, small intestinal bacterial overgrowth (SIBO), None of the above)	During the past 3 months before the survey

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2017
• Primary Completion (ACTUAL): September 15, 2017
• Study Completion (ACTUAL): September 15, 2017

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (ACTUAL): April 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 17-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No