A Prospective, Randomized, Investigator Blinded, Controlled Trial to Evaluate the Effectiveness of Dietary Modification in Patients With Functional Dyspepsia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Self report of adequate relief
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Low FODMAP
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.
Intervention: Low FODMAP Diet (Behavioral)
Choose My Plate
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.
Intervention: Choose My Plate Diet (Behavioral)
Outcomes
Primary Outcomes
Self report of adequate relief
Time Frame: 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 Outcomes
- Improvement in the NDI short form(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(Week 10 (after low FODMAP reintroduction))