800 Participants NeededMy employer runs this trial

IgG Binding Protein LT for Gut Health

AM
JK
Overseen ByJane Kohan

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if IgG Binding Protein LT supports gut health for travelers to Africa, Asia, or Latin America and the Caribbean. Participants will take either the protein or a placebo (a pill with no active ingredient) during their trip to assess its effects on digestion, stool frequency, and overall gut wellness. It suits healthy individuals who have more than three bowel movements a week and plan to travel internationally for 7 to 21 days. As an unphased trial, this study provides a unique opportunity for travelers to contribute to research that could improve gut health during international trips.

Is there any evidence suggesting that IgG Binding Protein LT is safe for gut health?

Research has shown that reactions involving IgG, such as those with IgG Binding Protein LT, usually cause milder symptoms. This suggests that most people might tolerate the treatment well. For example, studies on IgG-related food intolerances often find that reactions are delayed and less severe than immediate allergies. Although specific data on side effects for IgG Binding Protein LT is lacking, evidence suggests that serious safety issues are unlikely. Approval for another condition would offer clearer safety assurance, but this is not the case here.12345

Why are researchers excited about this trial?

Unlike the standard treatments for gut health, which often include probiotics or dietary changes, IgG Binding Protein LT offers a novel approach by directly targeting IgG antibodies in the gut. This treatment works by potentially binding to and neutralizing harmful substances in the digestive system, aiming to improve gut health in a more targeted way. Researchers are excited about IgG Binding Protein LT because it represents a new mechanism of action that could provide relief for patients who do not benefit from current options. Additionally, its oral capsule form makes it easy to administer, potentially increasing patient compliance.

What evidence suggests that IgG Binding Protein LT might be an effective treatment for gut health?

Research shows that IgG Binding Protein LT (BP-LT), which participants in this trial may receive, may help maintain gut health by attaching to harmful substances in the digestive system. Early studies suggest it is safe to consume, as it does not appear to cause allergies or genetic issues. This protein helps maintain gut balance by interacting with toxins from harmful bacteria like C. difficile. While more evidence is needed to confirm its effectiveness in easing gut symptoms for travelers, its safety appears promising. The treatment might enhance the gut's defense against harmful elements, supporting overall gut health.678910

Who Is on the Research Team?

AM

Ashley Mateus

Principal Investigator

People Science, In.c.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-70 in the US who are planning to travel for 7-21 days to Africa, Asia, or Latin America/Caribbean. Participants should not have major health issues affecting gut function.

Inclusion Criteria

Able to read and understand English
Able to consume one capsule (vegan friendly) of Study Product or Placebo twice daily, not on empty stomach
In good general health at time of screening (Investigator discretion)
See 8 more

Exclusion Criteria

Significant acute or chronic coexisting health conditions preventing study fulfillment, posing risk, or confounding results including diagnosed gastrointestinal or immunocompromised conditions, or severe discomfort on GSRS
Currently pregnant, planning pregnancy during study, or lactating/breastfeeding
Significant illness or condition impacting ability to participate or study outcomes per principal investigator
See 12 more

Timeline for a Trial Participant

Pre-screening

Participants complete an online pre-screening questionnaire to assess initial eligibility

Up to 4 weeks

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Pre-travel hold

Randomization and shipping of study materials occur before participants' departure

Up to 2 weeks

Baseline

Participants establish baseline measurements at home before travel

14 days

Treatment

Participants take the study medication or placebo while traveling

7-21 days

End-of-study

Participants complete final assessments upon return from travel

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IgG Binding Protein LT

Trial Overview

The study tests whether a supplement called IgG Binding Protein LT (BP-LT) can support gut health during international travel compared to a placebo. Participants take capsules twice daily while traveling. The study is randomized and double-blind.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: IgG Binding Protein LTExperimental Treatment1 Intervention
Group II: PlaceboPlacebo 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+

Citations

Allergenicity, Genotoxicity and Subchronic Toxicity ... - PMC

IgG binding protein LT is highly unlikely to pose a risk of allergenic cross‐reactivity, and there was no evidence of genotoxicity in vitro.

IgG Binding Protein LT in Support of a Healthy Gut on the Go

It evaluates whether IgG Binding Protein LT (BP-LT), supports gut health in healthy US adults aged 18-70 travelling 7-21 days to Africa, Asia ...

Genotoxicity, subchronic toxicity, and allergenicity ...

IgG Binding Protein CBB facilitates the safe passage of TcdB; a toxin secreted by C. difficile, through the gastrointestinal tract helping to maintain gut ...

4.

analyticalsciencejournals.onlinelibrary.wiley.com

analyticalsciencejournals.onlinelibrary.wiley.com/doi/pdf/10.1002/jat.4787

Allergenicity, Genotoxicity and Subchronic Toxicity ...

IgG binding protein LT is highly unlikely to pose a risk of allergenic cross- reactivity, and there was no evidence of genotoxicity in vitro.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40288785/

Allergenicity, Genotoxicity and Subchronic Toxicity ...

IgG binding protein LT is highly unlikely to pose a risk of allergenic cross-reactivity, and there was no evidence of genotoxicity in vitro.

Articles on: Gut & immune health | International

Gut microbiota may be potential target for better health outcome in elderly Milk fat globules and immune health Role of bovine IgG in human immunity Minimal ...

Leaky Gut and IgG Food Intolerance

The avoidance of IgG positive foods is the key to success for restoring selective gut permeability (abolishing leaky gut), and improve food tolerance

Gut Health & Food Sensitivities: The Testing Duo You Need

00:00 Introduction to Gut Health Challenges ; 00:31 The Power of Combining GI MAP and IgG Food Explorer ; 01:02 When to Order Both Tests ; 01:44 ...

Gastrointestinal Food Allergies and Intolerances

Journal of Allergy and Clinical Immunology, 2001. The diagnostic significance of IgG cow's milk protein antibodies re-evaluated. European Journal of ...

(PDF) Role of IgG food test in patients with allergic diseases

After food avoidance, the skin and gastrointestinal tract, respiratory, and CNS symptoms were improved. The study findings may indicate primary prevention of ...