Bactolife A/S
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.
Design and duration: Approximately 40 healthy adult volunteers (ages 18-70, balanced by sex and age) will be randomized 1:1 to receive either the study product BP-LT or a matching placebo capsule, taken twice daily (morning after breakfast, evening after dinner) for 3 weeks. Participants, investigators, and study staff are all blinded to group assignment. Total individual participation spans up to 11 weeks: a screening period (up to 4 weeks), a randomization/shipping period (up to 2 weeks), a 1-week baseline period, a 3-week product/placebo use period, and a 1-week end-of-study period. The en…
Inclusion Criteria: 1. 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). 2. In good general health at the time of screening (Investigator discretion). 3. Able to read and understand English. 4. Able to read, understand, and provide informed consent. 5. Self reports more than 3 bowel movements in the Chloe App in a 7 day period before or during screening. 6. Able to consume one capsule (allergen and vegan friendly) the Study Product or Placebo twice daily, not on an empty stom…
Dietary supplement containing IgG Binding Protein LT
Dietary supplement without IgG Binding Protein LT
Arctuva estimate
Verify or correct the compensation shown for this listing.