Impact of a Human Origin Heat Inactivated Probiotic-Lactobacillus Paracasei D3.5 (LpD3.5) as Dietary Supplement on Gut Mucin and Intestinal Permeability in Adults With IBD

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07017959
Status
Not Yet Recruiting

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Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LpD3.5 supplementation. — DIETARY_SUPPLEMENT
    Dietary Supplement: LpD3.5 are in the form of capsule where LpD3.5 contains 167 mg of LpD3.5, with the remaining portion consisting of inactive ingredients like maltodextrin
  • Placebo — DIETARY_SUPPLEMENT
    Placebo capsules contain only inactive ingredient maltodextrin

Study Details

This study aims to study a biological phenomenon of reduced mucin barriers that are linked with increased intestinal permeabil-ity in the gut of individuals with IBD and determine whether and how a human originated, and heat inactivated probiotic LpD3.5 impact these biological mechanisms. We plan a cross-over ran-domized placebo-controlled pilot study of n=15 individuals with IBD, who will be consented with a goal for 10 participants ran-domized in placebo (n=5) and LpD3.5 (n=5) arms to complete the study and will be given two corresponding dietary supple-ment grade capsules per day of placebo or LpD3.5 (167 mg/ capsule), respectively, for 60 days. We will have a 60-day washout period, after which participants will be cross-over in opposite arms and further intervention will be monitored at 30 and 60 days. Stool and blood samples will be collected at base-line (before intervention), and after 30, and 60 days of the start of the intervention. After a 60-day washout interval, the sample collection will be performed in a crossover fashion in opposite arms. We will analyze the levels of post-intervention fecal mucin (marker of gut barriers) between LpD3.5 and placebo groups as primary outcomes. Microbiome indices and phylogenetic abun-dances, and markers of elevated gut permeability (LBP and sCD14) will be as secondary outcomes. Our exploratory out-comes will include inflammation (IL-6, TNF-α, and IL-1β in blood, and calprotectin in feces), dose and frequency of medica-tions, and QOL questionnaires.

Key Dates

Start date
Jun 15, 2025
Status verified
Jun 2025
Primary completion
Dec 15, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING

Arms

  • Experimental: Experimental group
    LpD3.5 supplementation.
  • Placebo Comparator: Placebo Comparator
    Placebo supplementation.

Primary Outcome Measure

Levels of post-intervention fecal mucin (marker of gut barriers) between LpD3.5 and placebo groups [ Time Frame: At baseline (pre), 60 days post intervention and 180 days post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33612-

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By research site
University of South Florida· Tampa, FL

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