Safety and Tolerability Evaluation of IgG Binding Protein LT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBactolife A/S
About this trial
This study evaluates the safety and tolerability of the food ingredient IgG Binding Protein LT (BP-LT) when added to a daily diet. BP-LT is a stable protein ingredient being functional in the gastrointestinal tract and without systemic absorption. This registration covers a decentralized, randomized, double-blind, placebo-controlled clinical study evaluating BP-LT in healthy adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-70 years of age, inclusive, or the legal age of majority in the participant's state of residence (e.g., 19 years for Alabama and Nebraska; 21 years for Mississippi).
In good general health at the time of screening (Investigator discretion).
Able to read and understand English.
Able to read, understand, and provide informed consent.
Disqualifiers
Do not have a personal smartphone, internet access, or unwilling to download Chloe.
Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
Currently pregnant, of childbearing potential, planning to become pregnant during participation in the study, or are lactating/breastfeeding.
Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
Trial design
Design model
Parallel
Treatments tested in this trial
IgG Binding Protein LT
Dietary supplementDietary supplement containing IgG Binding Protein LT
Placebo
Dietary supplementDietary supplement without IgG Binding Protein LT
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: IgG Binding Protein LTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety and tolerability of a 3-week, twice-daily intake of IgG Binding Protein LT (BP-LT) in healthy adults.
The incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) per product causality.
Time frame
From Baseline to Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bactolife A/S
Lead sponsor
People Science, Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: