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Trial Outcomes & Findings for Impact of Diet on Functional Gastrointestinal Symptoms (NCT NCT03102411)

NCT ID: NCT03102411

Last Updated: 2019-01-25

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

1881 participants

Primary outcome timeframe

During the past 3 months before the survey

Results posted on

2019-01-25

Participant Flow

The online survey took place from 3/9/2017 to 3/11/2017 through SurveyMonkey® (Palo Alto, CA, USA). The survey was distributed securely to a representative sample of the US population. 1881 subjects responded to the survey with 1718 completing all the questions (91% completers).

Participant milestones

Participant milestones
Measure
GI Symptoms Survey
The survey participants are men and women between the ages of 18 and 80 in the United States
Overall Study
STARTED
1881
Overall Study
COMPLETED
1718
Overall Study
NOT COMPLETED
163

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

8 subject didn't answer the question of asking "Gender".

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
GI Symptoms Survey Population
n=1718 Participants
The Survey participants are men and women between the ages of 18 and 80 in the United States
Age, Customized
18-30 years
347 Participants
n=1718 Participants
Age, Customized
31-45 years
506 Participants
n=1718 Participants
Age, Customized
46-60 years
502 Participants
n=1718 Participants
Age, Customized
61-80 years
351 Participants
n=1718 Participants
Age, Customized
Prefer not to answer
12 Participants
n=1718 Participants
Sex: Female, Male
Female
911 Participants
n=1710 Participants • 8 subject didn't answer the question of asking "Gender".
Sex: Female, Male
Male
799 Participants
n=1710 Participants • 8 subject didn't answer the question of asking "Gender".
Race/Ethnicity, Customized
Caucasian/White
1365 Participants
n=1718 Participants
Race/Ethnicity, Customized
African American/Black
111 Participants
n=1718 Participants
Race/Ethnicity, Customized
Native American
21 Participants
n=1718 Participants
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
10 Participants
n=1718 Participants
Race/Ethnicity, Customized
Asian
70 Participants
n=1718 Participants
Race/Ethnicity, Customized
Prefer not to answer
41 Participants
n=1718 Participants
Race/Ethnicity, Customized
Other
100 Participants
n=1718 Participants
Region of Enrollment
United States
1718 participants
n=1718 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
GI Symptom Survey Population
n=1718 Participants
The survey participants are men and women between the ages of 18 and 80 in the United States.
Most Common Triggers for Food-related GI Symptoms (Top 5)
Fried or greasy foods
881 Participants
Most Common Triggers for Food-related GI Symptoms (Top 5)
Dairy products
494 Participants
Most Common Triggers for Food-related GI Symptoms (Top 5)
Beans
469 Participants
Most Common Triggers for Food-related GI Symptoms (Top 5)
Chili peppers
460 Participants
Most Common Triggers for Food-related GI Symptoms (Top 5)
Alcohol
354 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
GI Symptom Survey Population
n=1718 Participants
The survey participants are men and women between the ages of 18 and 80 in the United States.
Self-reported Functional GI Disorders
Acid reflux (GERD)
411 Participants
Self-reported Functional GI Disorders
Irritable bowel syndrome (IBS)
161 Participants
Self-reported Functional GI Disorders
Celiac diseas
23 Participants
Self-reported Functional GI Disorders
Inflammatory bowel disease
33 Participants
Self-reported Functional GI Disorders
Diverticulitis
72 Participants
Self-reported Functional GI Disorders
Gastroparesis
26 Participants
Self-reported Functional GI Disorders
Leaky gut
20 Participants
Self-reported Functional GI Disorders
Small intestinal bacterial overgrowth (SIBO)
12 Participants
Self-reported Functional GI Disorders
None of the above
1116 Participants

Adverse Events

GI Symptoms Survey Population

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Pauls MD

TriHealth Inc.

Phone: 513-463-4300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place