The VIVA trial is a 12-week, randomized, interventional study comparing vonoprazan monotherapy versus vonoprazan plus itopride combination therapy in adults with functional dyspepsia (FD). FD is a common digestive disorder causing upper stomach discomfort, fullness after meals, and early satiety.
The study aims to determine if adding itopride, a prokinetic that improves stomach emptying, to vonoprazan, a strong acid-suppressing drug, provides better symptom relief than vonoprazan alone. Participants will be randomly assigned to receive either treatment, and their symptoms, quality of life, and safety outcomes will be monitored throughout the study.
The trial will help guide the best management strategy for FD by targeting both acid-related and motility-related symptoms.
Confirmed Functional Dyspepsia (FD): As per Rome IV criteria: Symptoms for ≥3 days/week over the last 3 months.
Prior endoscopy with normal findings or minor gastritis within the last 3 months.
Negative Helicobacter pylori test (Rapid urease test) or urea breath test
The patient should be off Proton pump inhibitors for 2 weeks
Evidence of structural/biochemical issues like peptic ulcer, erosive esophagitis, gastric/esophageal malignancy, pancreato-biliary disorders Overlapping functional GI Disorders: IBS
Uncontrolled systemic diseases (e.g., uncontrolled diabetes), major psychiatric disorders (e.g., severe depression), or neurological disorders affecting Gastrointestinal motility.
Use of medications that affect gastrointestinal motility or symptom perception (e.g., chronic opioid analgesics, anticholinergic drugs, benzodiazepines).
Pregnancy or Lactation
Parallel
Vonoprazan plus Itopride combination
DrugParticipants will receive vonoprazan 20 mg orally once daily (preferably in the morning) for 12 weeks, plus itopride 50 mg orally thrice daily before meals for 12 weeks. The vonoprazan dose of 20 mg daily is chosen as it is the standard dose shown to provide potent acid suppression
Vonoprazan
DrugParticipants will receive vonoprazan 20 mg orally once daily for 12 weeks
Symptom Relief in Functional Dyspepsia
Proportion of participants achieving significant improvement in dyspepsia symptoms, assessed by the Leeds Dyspepsia Questionnaire (LPDS) score -The scale range from 0 to 7 7 is the highest score of anxiety/ depression, 0 is the least score.
Quality of Life Improvement
Change in Nepean Dyspepsia Index (NDI) scores , the scale range from 10 (Gastrointestinal symptoms effecting low level to the patient , 50 (Gastrointestinal symptoms affecting badly to the patinet) baseline to week 12.
Responder Rate
Proportion of participants with ≥50% improvement in Leuven post prandial distress score (nausea, belching, heartbun scores questionares 4 indicates severe, 0 indicates no symtoms)
Safety and Tolerability
Incidence of adverse events and laboratory abnormalities in each group.
Rescue Medication Use
To calculate the frequency of antacid or analgesic use during the study period.
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