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