Functional Dyspepsia | Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Functional Dyspepsia research study
What is the primary objective of this study?
Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal, hypersensitivity of the afferent nerves of the gut, psychological disturbances and central nervous system dysfunction have been proposed. Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only small benefits relative to placebo have been found with histamine H2 receptor antagonists, proton pump inhibitor and Helicobacter pylori eradication. Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is currently indicated for patients with various upper GI symptoms. This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking test)and symptoms in FD patients
Who is eligible to participate?
Inclusion Criteria: 1. All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered 2. Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test. 3. duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology 4. A normal upper abdominal ultrasound 5. Willing to participate and give consent for participation in the study. Exclusion Criteria: 1. Age <18 years 2. Helicobacter Pylori positive on gastric biopsy and / or UBT. 3. Taking other medications that alter gastric motility like macrolide - anti-emetics and antibiotics . 4. Pregnant or breast-feeding females.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Itopride,Itopride,50 mg capsules,thrice a day,for Four weeks
Drug:Placeboplacebo capsules,thrice a day for four weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1.Itopride GroupThe itopride group will receive itopride 150mg per day(50mg TDS)for four weeks
2.Control placebo groupThe control group will receive placebo tablets for four weeks
Start Date: February 2009
Completed Date: May 2011
Primary Outcome: To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia
Secondary Outcome: To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia
Study sponsors, principal investigator, and references
Principal Investigator: Shahab Abid, MD
Lead Sponsor: Aga Khan University