Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.

Not Applicable

Withdrawn

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Low FODMAP	Low FODMAP Diet	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.
Choose My Plate	Choose My Plate Diet	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.

Primary Outcome Measures

Name	Time	Method
Self report of adequate relief	Week 7 (after 4 weeks of diet modification)	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

Secondary Outcome Measures

Name	Time	Method
Improvement in the NDI short form	Week 7 (after 4 weeks of diet modification)	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.
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	Week 10 (after low FODMAP reintroduction)	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.

Locations (1): Advocate Lutheran General Hospital
🇺🇸
Park Ridge, Illinois, United States