Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Dyspepsia; Dietary Modification

Treatments: Behavioral: Low FODMAP Diet; Behavioral: Choose My Plate Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02863822

2015-203

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Low FODMAP

Experimental group

Description:

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.

Treatment:

Behavioral: Low FODMAP Diet

Choose My Plate

Active Comparator group

Description:

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.

Treatment:

Behavioral: Choose My Plate Diet