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Completed

NCT Number: NCT03102411

Impact of Diet on Functional Gastrointestinal Symptoms

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.

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Key information

Conditions

Gastrointestinal Disorder, Functional Digestive System Diseases Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Self-reported Functional GI Disorders

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2017
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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