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
University of South Florida
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.
Description
IBD is becoming more common in both developed and developing nations, putting a significant strain on the healthcare system. IBD is now a major public health problem that affects \~3.6 million people in the United States and Europe. In 2019, there were approximately 4.9 million cases of IBD worldwide, with China and the USA having the maximum number of cases (911 405 and 762 890 (66.9 and 245.3 cases per 100,000 people, respectively). Accumulating evidence suggests that an abnormal gut microbiota composition, termed as dysbiosis, plays a key role in the pathogenesis of IBDs such as ulcerative…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 years or older. 2. 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 3. Participants who can provide informed consent with a signature. 4. Body mass index (BMI) between 18 and 40 kg/m² 5. English Speaking Exclusion Criteria: Participants meeting any of the following criteria will be excluded: 1. History of severe GI surgery. 2. History of antibiotics, diarrhea, or vomiting within the past 30 days. 3. Use of intravenous cort…
Interventions
- Dietary SupplementLpD3.5 supplementation.
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
- Dietary SupplementPlacebo
Placebo capsules contain only inactive ingredient maltodextrin
Location
- University of South FloridaTampa, Florida