Dyspepsia Clinical Trial
Official title:
A Prospective, Randomized, Investigator Blinded, Controlled Trial to Evaluate the Effectiveness of Dietary Modification in Patients With Functional Dyspepsia
Verified date | April 2018 |
Source | Advocate Health Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Advocate Lutheran General Hospital | Park Ridge | Illinois |
Lead Sponsor | Collaborator |
---|---|
Advocate Health Care |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Improvement in the NDI short form | 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. | Week 7 (after 4 weeks of diet modification) | |
Secondary | Improvement in the Global Overall Symptom Scale | Week 7 (after 4 weeks of diet modification) | ||
Secondary | Continued Improvement in the Global Overall Symptom Scale | Week 10 (after low FODMAP reintroduction) | ||
Secondary | Continued Improvement in the NDI short form | 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. | Week 10 (after low FODMAP reintroduction) |
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