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Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02863822
Recruitment Status : Withdrawn (no patients enrolled)
First Posted : August 11, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hina Omar,MD, Advocate Health Care

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Dietary Modification Behavioral: Low FODMAP Diet Behavioral: Choose My Plate Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Improvement in the Global Overall Symptom Scale [ Time Frame: Week 7 (after 4 weeks of diet modification) ]
  3. Continued Improvement in the Global Overall Symptom Scale [ Time Frame: Week 10 (after low FODMAP reintroduction) ]
  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Illinois
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Advocate Health Care
Investigators
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Principal Investigator: Hina Omar, MD Advocate Lutheran General Hospital
Principal Investigator: Marc Fine, MD Advocate Lutheran General Hospital
Publications:

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Responsible Party: Hina Omar,MD, Hina Omar, MD Chief Resident, Advocate Health Care
ClinicalTrials.gov Identifier: NCT02863822    
Other Study ID Numbers: 2015-203
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: No plan to make individual participant data available. Poster presentation, Manuscript publication, oral presentations are planned.
Keywords provided by Hina Omar,MD, Advocate Health Care:
Functional Dyspepsia
Low FODMAP
Dietary Modification
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive