At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 472 enrolled
Drug / intervention
Otilonium Bromide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial to Evaluate the Short-term Efficacy and Long-term Health Economic Impact of a Dietary Intervention Compared to Pharmacotherapy With a Musculotropic Spasmolytic Agent for Newly Diagnosed or Newly Treated Irritable Bowel Syndrome in Primary Care
In Brief
A Phase 4 clinical trial evaluating IBS Diet and Otilonium Bromide for Irritable Bowel Syndrome. Completed, enrolled 472 participants across 1 site.
Detailed Summary
A randomized controlled trial to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic agent for newly diagnosed or newly treated irritable bowel syndrome in primary care.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesBelgium
Collaborators--
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
Enrollment StartJul 2018
First PostedFeb 2020
Primary CompletionMay 2020
Study CompletionJul 2020
TodayJul 2026
First PostedFeb 17, 2020
Enrollment StartJul 26, 2018
Primary CompletionMay 4, 2020
Study CompletionJul 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.4 years ago
Interventions
IBS Dietother
Patients will be randomized to a diet or a mediation treatment
Otilonium Bromidedrug
Patients will be randomized to a diet or a mediation treatment