IgG Binding Protein LT for Safety Evaluation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the safety and tolerability of a food ingredient called IgG Binding Protein LT (BP-LT) when added to a daily diet. BP-LT functions in the digestive system and does not enter the bloodstream. Participants will take capsules containing either BP-LT or a placebo (a pill with no active ingredient) twice a day. Individuals who are healthy, have more than three bowel movements a week, and can use a smartphone app may be suitable for this trial.
As an unphased trial, this study allows participants to contribute to the scientific understanding of BP-LT's safety and tolerability in everyday diets.
Do I need to stop taking my current medications for the trial?
You may need to stop taking certain medications, like systemic antibiotics, proton pump inhibitors, and NSAIDs, before joining the trial. It's best to discuss your current medications with the study team to see if they might interfere with the trial.
What prior data suggests that IgG Binding Protein LT is safe for consumption?
In a previous study, researchers tested IgG Binding Protein LT for safety. They assessed its potential to cause allergies or genetic issues using computer models and lab tests. These studies found no evidence of allergies or harmful genetic changes.
Another study examined the protein's effects over a longer period, known as subchronic toxicity. The results showed that IgG Binding Protein LT was well-tolerated, with no adverse reactions. This evidence suggests that the protein is generally safe for use.12345Why are researchers excited about this trial?
IgG Binding Protein LT is unique because it targets specific immune pathways by binding to immunoglobulin G (IgG), which is a different approach compared to most current treatments for autoimmune conditions that often focus on broad immunosuppression. This targeted mechanism could potentially reduce side effects associated with widespread immune system suppression. Additionally, the oral capsule form of IgG Binding Protein LT offers a convenient delivery method, making it easier for patients to adhere to the treatment regimen. Researchers are excited about the possibility of achieving more precise immune modulation with fewer side effects, which could lead to improved quality of life for patients.
What evidence suggests that IgG Binding Protein LT is effective for safety and tolerability in healthy adults?
Studies have shown that IgG Binding Protein LT is a promising ingredient for improving gut health. Participants in this trial will receive either IgG Binding Protein LT or a placebo. A thorough safety check found this protein to be non-allergenic, making allergic reactions unlikely. Research also shows that it does not harm the genetic material in cells. The protein attaches to IgG, a type of antibody, which may help manage immune responses in the gut. These findings suggest that IgG Binding Protein LT could safely support digestive health without entering the bloodstream.12345
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization/Shipping
Participants are randomized and study products are shipped
Baseline
Participants establish baseline measurements before starting the product/placebo
Treatment
Participants receive the study product or placebo twice daily
End-of-Study
Participants complete final assessments and biospecimen collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Received oral capsules twice daily containing IgG Binding Protein LT
Received oral Placebo capsules twice daily without IgG Binding Protein LT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bactolife A/S
Lead Sponsor
People Science, Inc.
Industry Sponsor
Citations
The Missing Protection Layer in Microbiome Care
A 2025 assessment of IgG Binding Protein LT included computational allergenicity screening, bacterial reverse-mutation testing, an in vitro ...
Evaluating Potential Risks of Food Allergy of Novel ...
To support the safety of IgG binding protein LT for such use, a comprehensive safety assessment (in silico allergenicity assessment, in vitro genotoxicity ...
IgG-Engineered Protective Antigen for Cytosolic Delivery of ...
Harnessing this dual-targeting approach holds promise for enhancing immunotoxin safety and treatment responses in findings of prolonged clearance time
Works in Journal of Applied Toxicology, 2025, Vol 45, Issue 8
Allergenicity, Genotoxicity and Subchronic Toxicity Assessment of IgG Binding Protein LT Produced From Aspergillus oryzae. Published in: Journal of Applied ...
Preclinical Immune Response and Safety Evaluation of the ...
The data in Figure 3C indicate that the levels of S protein-specific IgG in the vaccinated groups were significantly increased in a time-dependent manner.
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