The market for Probiotics and Live Biotherapeutic Products (LBPs) is driven by the demand for scientifically backed gut health solutions. The ability of your strain to maintain or restore the Gut Barrier Integrity—the body's first line of defense—is a critical, high-value claim. Creative Biolabs specializes in the comprehensive efficiency evaluation of your LBPs, specifically focusing on their ability to maintain, restore, or enhance Gut Barrier Integrity. Leverage our cutting-edge platforms, robust assays, and expert scientific team to generate the high-quality data required for successful regulatory submissions and market entry. We don't just measure endpoints; we provide a clear, mechanistic understanding of your LBP's interaction with the intestinal epithelium, essential for IND submission and clinical success. Stop guessing—start proving its efficacy and safety.
Overview
Creative Biolabs offers end-to-end preclinical research services designed to rigorously test the impact of your LBP candidates (probiotics, consortia, fecal microbiota transplants, etc.) on the intestinal epithelial barrier. Our services range from in vitro mechanistic studies to complex in vivo efficacy models, with a focus on quantifiable, clinically relevant endpoints, including the analysis of Lipopolysaccharide Binding Protein (LBP) as a key marker of bacterial translocation.
Detailed Scope of Services
Workflow
Service Details
Molecular Endpoints
Samples
Deliverables
Turnaround Time
Model Systems
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Caco-2 Monolayer
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Caco-2/HT-29 Co-culture
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Co-culture with Immune Cells: Addition of THP-1 monocytes or PBMCs. Assessing combined barrier and anti-inflammatory effects.
Core Functional Assays
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Transepithelial Electrical Resistance (TEER): Electrical resistance across the monolayer, the gold standard for TJ tightness.
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Paracellular Permeability: Translocation of inert molecular probes (e.g., FITC-Dextran) from apical to basolateral chamber.
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Bacterial Translocation Assay: Monitoring the passage of an inducing pathogen (or the test probiotic itself) across the compromised barrier.
Molecular Endpoints
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Tight Junction Protein Expression: Western Blot or qPCR to quantify key proteins:
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Scaffolding Proteins: ZO-1, ZO-2 (critical for TJ structure).
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Transmembrane Proteins: Occludin, Claudin family (regulating permeability).
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Inflammatory Markers: ELISA for pro-inflammatory cytokines IL-6, IL-8, TNF-α) in the basolateral medium.
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Signaling Pathway Analysis: Investigating the activation of pathways like MAPK or AMPK via phosphorylation assays.
Sample Submission & Requirements
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Sample Type: Live or heat-inactivated single strains, multi-strain blends, fermented products, CFSS, or purified metabolites (SCFAs).
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Format: Sterile lyophilized powder (required CFU count specified) or liquid culture.
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Required Data: CoA (Certificate of Analysis), strain identity, viability/stability data, MSDS (Material Safety Data Sheet).
Deliverables
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Primary Data: Time-course TEER data.
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Mechanistic Data: High-resolution images (IF), band quantification (WB), and fold-change (qPCR/ELISA).
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Comprehensive Final Report: Detailed methodology, results, conclusions, and strategic recommendations.
Turnaround Time
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Standard TAT: 6-8 weeks (includes 3 weeks for cell differentiation and polarization).
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Fast-Track Option: Available for CFSS or metabolite-only screens (reduced time).
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Mechanism of Action (MoA) Elucidation for Gut Barrier Reinforcement
Understanding how your LBP acts is crucial for differentiation and IP. We design studies to uncover the precise MoA through which your product influences the intestinal barrier, including:
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Tight Junction (TJ) Modulation: Quantifying the effect of your LBP on the expression and localization of key TJ proteins (e.g., Zonulin-1, Occludin, Claudins) in epithelial cells.
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Mucus Layer Enhancement: Evaluating the production of mucins (MUC) and the thickness/quality of the protective mucus layer.
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Short-Chain Fatty Acid (SCFA) Impact: Measuring the production of SCFAs (Butyrate, Propionate, Acetate) and their direct/indirect signaling effects on barrier function, cellular energy, and anti-inflammatory pathways.
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Anti-inflammatory and Immune Modulation: Assessing the LBP's ability to suppress pro-inflammatory cytokines (e.g., TNF-α, IL-6, IL-1β) and promote anti-inflammatory mediators (e.g., IL-10) that can otherwise compromise barrier integrity.
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Enterocyte Health and Proliferation: Analyzing LBP's influence on intestinal epithelial cell viability, differentiation, and regeneration.
Advantages of Our Services
Focus on LBP
Specialized expertise in handling, culturing, and testing live microbial cultures.
Gold Standard In Vitro Models
High-Throughput Screening rapidly and cost-effectively screens multiple LBP candidates, doses, or formulations to identify the most potent barrier-modulating agent before moving to expensive in vivo trials.
Integrated Multi-Omics Ready
Seamless integration with our downstream microbiome sequencing (16S rRNA), metabolomics, and proteomics services to provide a holistic MoA picture.
Applications
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Efficacy Proof-of-Concept (PoC): Demonstrating the therapeutic activity of a novel LBP candidate for gut-related indications.
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Formulation/Dose Optimization: Comparing different LBP formulations or identifying the Minimum Effective Dose (MED) required to restore barrier function.
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Safety/Toxicity Assessment: Ensuring the LBP does not disrupt the barrier integrity, which is a key safety requirement.
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Biomarker Identification: Identifying changes in TJ proteins that can serve as clinical biomarkers in human trials.
Necessity of Testing
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De-Risk Clinical Trials: Screen out ineffective strains before expensive in vivo and human studies.
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Substantiate Claims: Provide the quantitative data required by regulatory agencies and marketing teams for "supports gut barrier function," "helps reduce intestinal permeability," or "protects against leaky gut" claims.
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Optimize Formulation: Identify the minimal effective dose (MED) or EC50 to optimize product potency and cost-effectiveness.
In the critical path of LBP development, delays due to ambiguous data are costly. Our advanced in vitro (e.g., Caco-2, organoids) and ex vivo models are tailored to your specific strains and therapeutic targets, offering a clear competitive advantage. Don't let gut barrier uncertainty stall your progress. The Next Step Is Simple: Schedule a Free 15-Minute Consultation, connect directly with one of our LBP Scientific Directors to discuss your specific strains, targets, and data requirements. There's no obligation—just expert guidance on how our tailored evaluation services can accelerate your journey from lab bench to clinic.
Contact us today to schedule a consultation and begin validating your probiotic's gut barrier protective effects.
Frequently Asked Questions (FAQs)
What exactly do your LBP Efficiency Evaluation Services measure?
We go beyond basic viability. Our services specifically measure how your LBP interacts with the intestinal epithelium. Key readouts include: Transepithelial Electrical Resistance (TEER) as a gold standard measure of tight junction integrity, molecular analysis of barrier proteins (e.g., Zonulin, Occludin), and quantification of permeability markers (e.g., flux of fluorescent dextrans). Essentially, we quantify the LBP's ability to maintain or restore a healthy, intact gut barrier.
Why is testing gut barrier integrity essential for my LBP?
A compromised gut barrier (often called "leaky gut") is implicated in numerous chronic diseases. For your LBP to be safe and effective, you must demonstrate two things: 1) The LBP itself does not damage the barrier. 2) The LBP can actively enhance or restore barrier function, which is often a key therapeutic mechanism of action. Our data provides the evidence for both.
What models do you use for gut barrier evaluation?
We utilize a tiered approach to match your development stage:
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In Vitro Models: Standardized Caco-2 and T84 cell monolayers for high-throughput screening and mechanistic studies.
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Advanced Models: State-of-the-art gut-on-a-chip microfluidic systems and patient-derived intestinal organoids for highly translational, physiologically relevant data that better mimic the human gut.
Can you evaluate my specific LBP strains and formulation?
Yes. Our protocols are fully customizable. We accept your proprietary LBP strains (e.g., Bifidobacteria, Lactobacillus, complex consortia) and test them directly in their relevant formulation matrices to ensure the results accurately reflect their intended use and stability.
