Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.

NCT02863822 | Withdrawn

• 1 other identifier: 2015-203
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia; Dietary Modification

Keywords

Functional Dyspepsia; Low FODMAP; Dietary Modification

Outcome Measures

Primary Outcomes (1)

• Self report of adequate relief

  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

  Week 7 (after 4 weeks of diet modification)

Secondary Outcomes (4)

• 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)

Study Arms (2)

Low FODMAP

EXPERIMENTAL

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

Choose My Plate

ACTIVE COMPARATOR

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

Interventions

Low FODMAP Diet BEHAVIORAL

Subjects in the experimental arm, will be educated in the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet.

Low FODMAP

Choose My Plate Diet BEHAVIORAL

Subjects in the active comparator arm will be educated in the ChooseMyPlate.gov Diet.

Choose My Plate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Related Publications (7)

• Staudacher HM, Lomer MC, Anderson JL, Barrett JS, Muir JG, Irving PM, Whelan K. Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome. J Nutr. 2012 Aug;142(8):1510-8. doi: 10.3945/jn.112.159285. Epub 2012 Jun 27.

  PMID: 22739368 BACKGROUND

• Ong DK, Mitchell SB, Barrett JS, Shepherd SJ, Irving PM, Biesiekierski JR, Smith S, Gibson PR, Muir JG. Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Aug;25(8):1366-73. doi: 10.1111/j.1440-1746.2010.06370.x.

  PMID: 20659225 BACKGROUND

• Kerckhoffs AP, Samsom M, van der Rest ME, de Vogel J, Knol J, Ben-Amor K, Akkermans LM. Lower Bifidobacteria counts in both duodenal mucosa-associated and fecal microbiota in irritable bowel syndrome patients. World J Gastroenterol. 2009 Jun 21;15(23):2887-92. doi: 10.3748/wjg.15.2887.

  PMID: 19533811 BACKGROUND

• Talley NJ, Dennis EH, Schettler-Duncan VA, Lacy BE, Olden KW, Crowell MD. Overlapping upper and lower gastrointestinal symptoms in irritable bowel syndrome patients with constipation or diarrhea. Am J Gastroenterol. 2003 Nov;98(11):2454-9. doi: 10.1111/j.1572-0241.2003.07699.x.

  PMID: 14638348 BACKGROUND

• Talley NJ, Van Zanten SV, Saez LR, Dukes G, Perschy T, Heath M, Kleoudis C, Mangel AW. A dose-ranging, placebo-controlled, randomized trial of alosetron in patients with functional dyspepsia. Aliment Pharmacol Ther. 2001 Apr;15(4):525-37. doi: 10.1046/j.1365-2036.2001.00941.x.

  PMID: 11284782 BACKGROUND

• Talley NJ, Locke GR, Saito YA, Almazar AE, Bouras EP, Howden CW, Lacy BE, DiBaise JK, Prather CM, Abraham BP, El-Serag HB, Moayyedi P, Herrick LM, Szarka LA, Camilleri M, Hamilton FA, Schleck CD, Tilkes KE, Zinsmeister AR. Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Gastroenterology. 2015 Aug;149(2):340-9.e2. doi: 10.1053/j.gastro.2015.04.020. Epub 2015 Apr 25.

  PMID: 25921377 BACKGROUND

• Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form. Aliment Pharmacol Ther. 2001 Feb;15(2):207-16. doi: 10.1046/j.1365-2036.2001.00900.x.

  PMID: 11148439 BACKGROUND

MeSH Terms

Conditions

Dyspepsia

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hina Omar, MD

  Advocate Lutheran General Hospital

  PRINCIPAL INVESTIGATOR

• Marc Fine, MD

  Advocate Lutheran General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: August 11, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 3, 2024

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)