IgG Binding Protein LT for Safety Evaluation

JK
AM
Overseen ByAshley Mateus, Ph.D
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Bactolife A/S

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

AM

Ashley Mateus, Ph.D

Principal Investigator

People Science, In.c.

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to help test the safety of a new food ingredient. People with health problems or certain conditions may not be able to join.

Inclusion Criteria

Able to read and understand English
In good general health at the time of screening (Investigator discretion)
Able to receive shipment of the product at an address within the United States
See 6 more

Exclusion Criteria

I have not received any experimental treatments in the past 30 days.
Any underlying medical conditions or comorbidities that may confound assessment of digestive symptoms or study outcomes
I have not recently used antibiotics, proton pump inhibitors, or NSAIDs.
See 11 more

What Are the Treatments Tested in This Trial?

Interventions

  • IgG Binding Protein LT

Trial Overview

The study tests a new protein ingredient called IgG Binding Protein LT (BP-LT) added to the daily diet, compared to a placebo. Participants are randomly assigned and neither they nor researchers know which group they're in.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Test armExperimental Treatment1 Intervention
Group II: Placebo armPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bactolife A/S

Lead Sponsor

People Science, Inc.

Industry Sponsor

Trials
7
Recruited
730+