The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage
Launched by CHR HANSEN · Jun 24, 2020
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
This trial is a single-site, randomized, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy volunteers aged 18 - 40 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 or placebo when co-administered to daily intake of 800mg of Ibuprofen.
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and Ibuprofen is co-administered.
Subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. Besides the screening visit, the tr...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Written informed consent
- • Healthy and without any gastrointestinal pain or other significant symptoms
- • Age 18 - 40 years
- • Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
- Exclusion Criteria:
- • -
About Chr Hansen
Chr. Hansen is a global leader in bioscience, specializing in the development of natural ingredient solutions for the food, pharmaceutical, and agricultural industries. With a strong commitment to innovation and sustainability, the company harnesses the power of microorganisms to enhance food safety, improve health outcomes, and promote environmental sustainability. Chr. Hansen's extensive portfolio includes probiotics, dairy cultures, enzymes, and natural colors, all backed by rigorous research and development. The organization is dedicated to advancing scientific knowledge through clinical trials and partnerships, ensuring the efficacy and safety of its products while contributing to a healthier and more sustainable future.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Patients applied
Trial Officials
Eamonn Quigley, Professor
Principal Investigator
Houston Methodist Gastroenterology Associates
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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