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

Launched by UNIVERSITY OF SOUTH FLORIDA · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a specific probiotic called Lactobacillus Paracasei D3.5 (LpD3.5) on people with Inflammatory Bowel Diseases (IBD). Researchers want to understand if this probiotic can help improve the gut's protective layer and reduce intestinal permeability, which is when the gut becomes too "leaky." The study will include 15 adults aged 18 and older with mild to moderate IBD symptoms. Participants will take either the probiotic or a placebo (a pill with no active ingredients) twice a day for 60 days, followed by a break before switching to the other treatment for another 60 days. Throughout the study, researchers will collect samples from participants to measure changes in gut health.

To be eligible for the trial, participants need to have a confirmed diagnosis of IBD for at least three months, have had a colonoscopy within the last two years, and be able to speak and understand English. They should also have a body mass index (BMI) between 18 and 40. However, people with certain conditions, such as severe gastrointestinal issues, recent antibiotic use, or those undergoing cancer treatment, cannot participate. This study is important because it may provide insight into how probiotics can support gut health for individuals living with IBD.

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Eligibility criteria

• 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 corticosteroids within 2 weeks before screening, during screen-ing, or during the study period.
• • 4. Diagnosis with cancer and/or going through chemotherapy/radiation therapy within the past 2 years.
• • 5. Dramatic weight change (\>20 pounds) in the past 2 weeks.
• • 6. Using other microbiome-influencing drugs or interventions.
• • 7. Participating in another clinical trial.
• • 11. 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.
• • 13. If they have heart disease, renal disease, active infection, gum bleeding disorder, severe diabetes, obesity (\>40 BMI), immunodeficiency, or thyroid disorders.
• • 14. 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.
• • 16. Any individuals classified in one of the vulnerable populations, including pregnant women, neonates, prisoners, and children