Impact of Diet on Functional Gastrointestinal Symptoms

Completed

• Conditions: Gastrointestinal Disorder, Functional

• Registration Number: NCT03102411
• Lead Sponsor: TriHealth Inc.

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.

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 Timeline

• Study Start: 2017-03-09
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-05
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Status Verified: 2018-05
• Results First Submitted: 2018-05-14
• Results First Submitted QC: 2018-08-02
• Results First Posted: 2019-01-18
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1881

Inclusion Criteria

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Most Common Triggers for Food-related GI Symptoms (Top 5)	During the past 3 months before the survey	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)

Secondary Outcome Measures

Name	Time	Method
Self-reported Functional GI Disorders	During the past 3 months before the survey	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)

Trial Locations

Locations (1)

Cincinnati Urogynecology Associates; 🇺🇸 Cincinnati, Ohio, United States