Safety and User Experience of BP-CBB
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBactolife A/S
About this trial
This study is the first-in human study for the food ingredient BP-CBB and aims aims to build on the excellent safety and tolerability observed in the extensive food safety assessment performed for BP-CBB, as well as the consumer experience with using the product, and to set the scene for future human studies documenting the health-benefits of daily supplementation with BP-CBB for diverse populations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Be able to give written informed consent.
Be between 18-65 years, both inclusive.
Record greater than 3 bowel movements recorded during the one-week run-in period.
In general, in good health, as determined by the investigator.
Disqualifiers
Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
Sexual partner(s) is/are exclusively female.
Trial design
Design model
Parallel
Treatments tested in this trial
BP-CBB
Dietary supplementDietary supplement containing BP-CBB
Placebo
Dietary supplementReceives dietary supplement without BP-CBB
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Test armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety and tolerability of once daily intake of the novel food ingredient BP-CBB in healthy adults
Incidence of all AEs per arm by product causality.
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bactolife A/S
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
Source ClinicalTrials.gov