Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.

Wake Forest University Health Sciences

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Dyspepsia Dietary Modification

Interventions

Low FODMAP DietBEHAVIORAL

Subjects in the experimental arm, will be educated in the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet.

Choose My Plate DietBEHAVIORAL

Subjects in the active comparator arm will be educated in the ChooseMyPlate.gov Diet.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Outcomes

Primary Outcomes

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

Time frame: Week 7 (after 4 weeks of diet modification)

Secondary Outcomes

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.

Time frame: Week 7 (after 4 weeks of diet modification)

Improvement in the Global Overall Symptom Scale

Time frame: Week 7 (after 4 weeks of diet modification)

Continued Improvement in the Global Overall Symptom Scale

Time frame: 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.

Time frame: Week 10 (after low FODMAP reintroduction)

Data from ClinicalTrials.gov

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