Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D): A Multicenter, Randomized, Prospective, Placebo-Controlled, Double-Blind, Phase IV Clinical Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
• Experiencing symptoms of IBS-D
• Having a diagnosis of IBS-D based on Rome IV criteria
• Participants with symptom onset at least 6 months before diagnosis
• Having a normal colonoscopy result in their medical file
Locations
Other Locations
Turkey
Ege University Faculty of Medicine, Gastroenterology Department
RECRUITING
Izmir
Contact Information
Primary
Burcu Sume
burcus@croturk.com
+90 312 479 88 75
Time Frame
Start Date: 2022-08-11
Estimated Completion Date: 2024-11
Participants
Target number of participants: 162
Treatments
Experimental: Intervention
Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks.
Placebo_comparator: Control
Participants in this group will be randomized to receive placebo for the following 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: Lallemand Health Solutions