Impact of a Human Origin Heat Inactivated Probiotic-Lactobacillus Paracasei D3.5 (LpD3.5) as Diet… (NCT07017959) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
United States15 participantsStarted 2025-06-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older.
✓. Individuals with a confirmed diagnosis of IBD, including:
✓. Participants who can provide informed consent with a signature.
✓. Body mass index (BMI) between 18 and 40 kg/m²
✓. English Speaking
Exclusion criteria
✕. History of severe GI surgery.
✕. History of antibiotics, diarrhea, or vomiting within the past 30 days.
✕. Use of intravenous corticosteroids within 2 weeks before screening, during screen-ing, or during the study period.
✕. Diagnosis with cancer and/or going through chemotherapy/radiation therapy within the past 2 years.
✕. Dramatic weight change (\>20 pounds) in the past 2 weeks.
✕
What they're measuring
1
Levels of post-intervention fecal mucin (marker of gut barriers) between LpD3.5 and placebo groups
Timeframe: At baseline (pre), 60 days post intervention and 180 days post intervention
. Using other microbiome-influencing drugs or interventions.
✕. Participating in another clinical trial.
✕1.1 Probiotic use is defined as consumption of ≥108 CFU/day, in the form of tablets, capsules, lozenges, powders, or dairy products in which probiot-ics are a major ingredient 12. Heavily consuming (\>2 servings per day) yogurt, kefir, kombucha and other fermented food products that can influence microbiome.