Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.
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|ClinicalTrials.gov Identifier: NCT02863822|
Recruitment Status : Withdrawn (no patients enrolled)
First Posted : August 11, 2016
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia Dietary Modification||Behavioral: Low FODMAP Diet Behavioral: Choose My Plate Diet||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective, Randomized, Investigator Blinded, Controlled Trial to Evaluate the Effectiveness of Dietary Modification in Patients With Functional Dyspepsia|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: 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.
Behavioral: Low FODMAP Diet
Subjects in the experimental arm, will be educated in the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet.
Active Comparator: 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.
Behavioral: Choose My Plate Diet
Subjects in the active comparator arm will be educated in the ChooseMyPlate.gov Diet.
- 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
- Improvement in the NDI short form [ Time Frame: 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 [ 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863822
|United States, Illinois|
|Advocate Lutheran General Hospital|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Hina Omar, MD||Advocate Lutheran General Hospital|
|Principal Investigator:||Marc Fine, MD||Advocate Lutheran General Hospital|