Tests a probiotic supplement in adults with inflammatory bowel disease

Trial details

Who runs it

University of South Florida

Trial code

NCT07017959

Record updated

12 June 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Age 18 years or older; Individuals with a confirmed diagnosis of IBD, including:; History of IBD for more than 3 months; Last colonoscopy within 2 years of study entry; Mild to moderate IBD symptoms; Participants who can provide informed consent with a signature; Body mass index (BMI) between 18 and 40 kg/m²; English Speaking.

Exclusion: Use of intravenous corticosteroids within 2 weeks before screening, during screen-ing, or during the study period; Using other microbiome-influencing drugs or interventions; History of severe GI surgery; History of antibiotics, diarrhea, or vomiting within the past 30 days; Diagnosis with cancer and/or going through chemotherapy/radiation therapy within the past 2 years; If they have heart disease, renal disease, active infection, gum bleeding disorder, severe diabetes, obesity (>40 BMI), immunodeficiency, or thyroid disorders; History of anaphylaxis or allergies to probiotics or postbiotics. 15. Uncooperative behavior or any condition that could make the participant potentially non-compliant with the study procedures; Participants meeting any of the following criteria will be excluded:; Dramatic weight change (>20 pounds) in the past 2 weeks; Participating in another clinical trial; Ongoing use of non-study probiotics, prebiotics, synbiotics and postbiotics. They can be readmitted if stop such regimens for minimum 30 days; 11.1 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; Any individuals classified in one of the vulnerable populations, including pregnant women, neonates, prisoners, and children.

ClinicalTrials.gov NCT07017959