Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.

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.

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