Impact of Diet on Functional Gastrointestinal Symptoms; a National Population Based Survey
Conditions: Gastrointestinal Disorder, Functional
Sponsor: TriHealth Inc.

Pauls GI symptom and nutrition survey 1 
 
 
 
RESEARCH PROTOCOL 
 
Date 
3/1/17 
Title 
Impact of diet on functional gastrointestinal symptoms; a national 
population based survey 
Principal Investigator 
Rachel N. Pauls, MD 
Sub-Investigators 
Joshua Max, MD 
Research Specialist 
Eunsun Yook, MS 
Department 
Department of OB/Gyn, Division of Urogynecology and 
Reconstructive Pelvic Surgery; 
TriHealth Digestive Institute, Division of Gastroenterology 
Hatton # 
17-006 
 
Purpose of Study:  
 To delineate the role of diet in functional gastrointestinal (GI) symptoms.  
 To determine the prevalence of functional GI disorders in the general population. 
o Primary Aim: To describe common triggers for food-related GI symptoms. 
o Secondary Aims: To assess prevalence of self-reported functional GI disorders 
and awareness of dietary modification programs for GI symptoms. 
 
Hypothesis or Research Question  
 We hypothesize that functional GI symptoms are very common, and may not be 
associated with formal diagnoses. 
 We further hypothesize that certain foods may be triggers for symptoms, and that 
food ‘sensitivity’ is common in the population. 
 Finally, we hypothesize that the majority of people are aware of gluten-free eating 
but are less aware of other dietary treatments for GI symptoms. 
 
Background  
 
Hippocrates said “Let food be thy medicine, and medicine be thy food”1.  This quote rings true 
today, more than ever before.  Functional GI 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 sufferers2,3.  Moreover, many patients suffer in silence, with 67% of subjects waiting 
more than a year before treatment, and 11% waiting over 10 years4. Irritable bowel syndrome 
or IBS is the most prevalent functional GI disorder5, and several recent studies support the idea 
that dietary modifications may be  key to alleviating this condition6-16.   
 
Food sensitivities and reported intolerance to lactose, gluten, wheat, and carbohydrates are 
increasing globally.  While the mechanism is unclear, restriction of particular foods or food 
groups may alleviate functional GI symptoms.  Indeed, both gluten-free and low-FODMAP diets 

Pauls GI symptom and nutrition survey 1 
 
have been shown to reduce symptoms in affected patients, and not exclusively in those with 
celiac disease or lactose intolerance16,17.  
 
The low-FODMAP diet was initially described in 2006, and to date, dozens of well-designed 
studies have confirmed its benefit for IBS11,13-15,18-27. FODMAP is an acronym standing for 
Fermentable, Oligo, Di, and Mono-saccharides and Polyols.  These short-chain carbohydrates 
are poorly digested and can lead to symptoms of gas, bloating, diarrhea and constipation.  
Other disorders showing benefit from FODMAP restriction include inflammatory bowel 
disorders (Crohn’s disease and colitis), gastroparesis, diverticulitis, post-gastric resection and 
small intestinal bacterial overgrowth (SIBO)9,12,28-32.  Benefit from this eating plan has surpassed 
touted success of medications commonly prescribed for IBS, without the side effects and high 
cost1. 
 
Thus, the purpose of this study is to document GI symptoms among the US population, as well 
as to ascertain awareness and utilization of dietary treatments that exist.  Similar research has 
been conducted on small samples sizes in the United Kingdom17 but is lacking in the US.  This 
information is important in identifying knowledge gaps and will aid both physicians and 
dietitians to educate their patients about these programs.  Furthermore it is important for 
health care providers to understand the a priori knowledge and utilization of dietary 
modifications amongst sufferers of functional GI disorders. 
 
Research Plan  
 Study Design  
 This cross-sectional survey study will be administered through a secure online server 
at SurveyMonkey®. 
 
 Participants  
 The survey will be administered to men and women between the ages of 18 and 80.  
 Subjects will be recruited via email.   
 A cover email will explain how to access the survey and that participation is 
voluntary. 
 Email addresses will be obtained through  SurveyMonkey®. 
 The investigators will not have access to the email addresses or the subject contact 
information. 
 Exclusion Criteria: 
o Visual impairment. 
o Inability to read. 
o Inability to understand English. 
o Inability to use a computer to respond to questions. 
 
 Data Collection 
 The survey consists of questions regarding GI symptoms33, strategies for managing 
symptoms, foods that may trigger symptoms, and awareness of dietary plans for GI 
symptoms.   
 Demographic information will also be obtained. 

Pauls GI symptom and nutrition survey 1 
 
 The survey instrument is attached. 
 
 Intervention or experimental aspect of the study 
 There is no intervention. 
 
 
Statistical Analysis 
 Demographic data will be described using frequency (percentage) for categorical 
variables and mean (standard deviation) or median (interquartile range) for 
continuous variables.   
 Categorical data will be analyzed using Pearson’s chi-square or Fisher’s exact test; 
continuous data will be analyzed using Student’s t-test.  
o A goal of greater than 500 subjects is sought.  Sufficient emails will be obtained 
from SurveyMonkey® to accomplish this sample size. 
 
Ethical Considerations 
 Informed consent  
 By completing the survey, providers will be giving their consent to participate. No 
separate informed consent will be administered. 
 
 Privacy information 
 The surveys are completely confidential. No identifying information will be obtained.  
 
Cost/Budget 
 Approximately $3500 for the use of the email addresses. 
 
Estimated Period of Time to Complete Study 
When will study begin? 
2/1/2017 
Protocol Development 
Completed 
2 weeks 
Admin Review Time 
2 weeks  
IRB Approval 
3 weeks  
Data collection 
8 weeks 
Data analysis 
4 weeks 
Presentation development 
(if applicable) 
N/A 
Manuscript Development 
(if applicable) 
4 weeks 
Journal submission process 
(if applicable) 
6 months 
Study closure 
2 months 
 
  
 

Pauls GI symptom and nutrition survey 1 
 
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