Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet in functional dyspepsia (FD). The investigators will compare education in the low FODMAP diet to a standard healthy diet for improving symptoms in FD.

Detailed Description
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Functional Dyspepsia (FD) is defined by the Rome III criteria as bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning in the absence of structural or systemic disease that can explain the symptoms. These symptoms have been present for at least 3 months with symptom onset 6 months prior to the diagnosis. The low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet has been studied in irritable bowel syndrome (IBS) patients and has been shown to have modest benefit in a limited number of small studies. The diet is generally started by complete elimination of fructose, lactose, fructans, galactans, and polyols. Following symptom improvement, these groups are reintroduced one at a time while the patient monitors for symptoms. Although the low FODMAP diet has never been formally studied in patients with functional dyspepsia, we have noted the FD patients report improvement in their symptoms on the diet. This improvement could be explained by reduction in duodenal and gastric distention with the low FODMAP diet or a change in the duodenal flora. To date, there have been no randomized trials evaluating dietary modification in FD. The purpose of this study is to evaluate the efficacy of the low FODMAP diet in functional dyspepsia. The investigator's hypothesis is that the addition of the FODMAP diet to standard medical treatment will result in improved symptom control in patients with functional dyspepsia.

Official Title
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A Prospective, Randomized, Investigator Blinded, Controlled Trial to Evaluate the Effectiveness of Dietary Modification in Patients With Functional Dyspepsia

Conditions
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Dyspepsia, Dietary Modification

Intervention / Treatment
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* Behavioral: Low FODMAP Diet
* Behavioral: Choose My Plate Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 18 years and older Diagnosis of FD with either PDS or EPS as measured by Rome III Criteria Patients describing inadequate relief of dyspepsia symptoms Endoscopy performed in the last 3 years and negative for an organic cause for dyspeptic symptoms H pylori negative by non-invasive testing or biopsy. Patients with a history of successfully eradicated H pylori will be included if follow-up testing by stool antigen, urea breath testing, or biopsy is negative Celiac disease excluded by serologies or biopsy Exclusion Criteria: Patients with IBS predominant symptoms that are not well controlled Patients with a diagnosis of GERD who have uncontrolled heartburn History of esophagitis, ulcer disease, or other organic upper GI disease, including a diagnosis of celiac disease, gastroparesis, or vascular disorders of the upper GI tract History of surgery involving the esophagus, stomach, or duodenum Known lactose intolerance, unless symptoms persist on a lactose free diet Known fructose intolerance unless symptoms persist on a fructose free diet Patients undergoing active titration of any medications Pregnant or breastfeeding women Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low FODMAP<br>Subjects will be given dietary education in the low FODMAP diet, which they will continue for 4 weeks. Subjects will then followup with the dietician and subjects with a symptomatic response will be given instructions for reintroduction. | Behavioral: Low FODMAP Diet<br>* Subjects in the experimental arm, will be educated in the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet.<br>|
| Active Comparator: Choose My Plate<br>Subjects will receive dietary counseling in the choose my plate diet as defined by choosemyplate.gov. Subjects will also receive 2 dietician visits, 4 weeks apart. | Behavioral: Choose My Plate Diet<br>* Subjects in the active comparator arm will be educated in the ChooseMyPlate.gov Diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self report of adequate relief | Self report of adequate relief of dyspepsia symptoms for the previous 7 days. This information will be collected at week 7. This measure is considered clinically relevant and has been tested for responsiveness in FD | Week 7 (after 4 weeks of diet modification) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the NDI short form | The NDI short form is a validated questionnaire used to determine the severity of symptoms related to dyspepsia. It can be used to evaluate change over time. | Week 7 (after 4 weeks of diet modification) | 
| Improvement in the Global Overall Symptom Scale |  | Week 7 (after 4 weeks of diet modification) | 
| Continued Improvement in the Global Overall Symptom Scale |  | Week 10 (after low FODMAP reintroduction) | 
| Continued Improvement in the NDI short form | The NDI short form is a validated questionnaire used to determine the severity of symptoms related to dyspepsia. It can be used to evaluate change over time. | Week 10 (after low FODMAP reintroduction) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Dyspepsia, Low FODMAP, Dietary Modification