Safety and Tolerability Evaluation of IgG Binding Protein LT

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bactolife A/S
Study ID
NCT07824011
Status
Not Yet Recruiting

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Conditions

  • Safety and Tolerability in Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • IgG Binding Protein LT — DIETARY_SUPPLEMENT
    Dietary supplement containing IgG Binding Protein LT
  • Placebo — DIETARY_SUPPLEMENT
    Dietary supplement without IgG Binding Protein LT

Study Details

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.

Key Dates

First listed
Sep 17, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Test arm
    Received test product containing IgG Binding Protein LT
  • Placebo Comparator: Placebo arm
    Received Placebo product without IgG Binding Protein LT

Primary Outcome Measure

To evaluate the safety and tolerability of a 3-week, twice-daily intake of IgG Binding Protein LT (BP-LT) in healthy adults. [ Time Frame: From Baseline to Week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
People Science In.c.Los AngelesCalifornia90045
Jane Kohan
[email protected]
342-5681
Ashley Mateus, Ph.D
[email protected]
342-5681

Find similar trials in Los Angeles, CA

By research site
People Science In.c.· Los Angeles, CA

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