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

NCT07017959 | Not Yet Recruiting

• 1 other identifier: STUDY008123
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

Lactobacillus paracasei D3.5; Ulcerative colitis; Crohn's disease; Gastrointestinal symptom rating scale

Outcome Measures

Primary Outcomes (1)

• Levels of post-intervention fecal mucin (marker of gut barriers) between LpD3.5 and placebo groups

  The study determines whether LpD3.5 has any impact on the biological mechanism of mucin that regulates gut permeability. We will analyze whether the dietary grade (heat-killed) LpD3.5 capsule may change the levels of mucin in individuals with inflammatory bowel diseases (IBD).

  At baseline (pre), 60 days post intervention and 180 days post intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

LpD3.5 supplementation.

Dietary Supplement: LpD3.5 supplementation.

Placebo Comparator

PLACEBO COMPARATOR

Placebo supplementation.

Dietary Supplement: Placebo

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

Experimental group

Placebo DIETARY_SUPPLEMENT

Placebo capsules contain only inactive ingredient maltodextrin

Placebo Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• 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.
• Using other microbiome-influencing drugs or interventions.
• 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.
• 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.
• \. 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.
• \. Any individuals classified in one of the vulnerable populations, including pregnant women, neonates, prisoners, and children

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Shalini Jain, PhD

CONTACT

813-974-6281; jains10@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants receive one of the interventions (LpD3.5) during the initial phase of the study (for 60 days) and receive the other intervention (Placebo) during the second phase of the study

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: June 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

US (1)