Study Description
Vitabiotic is a prospective, randomised, double-blind, placebo controlled, multicentre, parallel group, phase II study. The study will recruit 130 patients across 13 centres in Belgium and they will undergo 5 study visits, plus a follow-up phone call (if they agree to free-access to DDI-IBS-001 for 4 additional weeks) with a total duration of 14 weeks.
Study Design & Method
IBS is a common chronic gastrointestinal condition that affects approximately 10-20% of adults in Western countries for more than 10 years. Patients with IBS experience chronic, episodic abdominal pain/discomfort, bloating and constipation and/or diarrhoea. Over 80% of individuals with IBS report food-related symptoms leading in the 70% of these patients to self-imposed food restrictions and/or modifications of their diet.The study consists of a 2-week run-in period (between V0 and V1) followed by an 8-week treatment period with daily DDI-IBS-001 (between V1 and V3). At the V3, patients will be divided into responders and non-responders based on their global symptoms' relief score, completion of electronic patient-reported outcomes (ePRO) and study product compliance.
Study Details
- Type: Prospective, randomized, double blind, placebo, controlled
- Disease: Irritable Bowel Syndrome
- Sites: 13 Sites across Belgium
- Start: Phase 2: 30 Nov 2023
- Population: 130 patients
- Duration: 14 weeks