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
Not applicable · Testing LpD3.5 supplementation. · 1 site · University of South Florida
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing LpD3.5 supplementation. (a dietary supplement) as a screening approach. Condition(s) listed: Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Age 18 years or older.
- Individuals with a confirmed diagnosis of IBD, including:
- History of IBD for more than 3 months
Plus 5 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 15 participants are expected to take part.
- Start date: 2025-06-15 (planned).
- Main results expected around 2025-12-15 (estimate from the record).
- 1 study site listed in United States.
Main thing being measured
- Levels of post-intervention fecal mucin (marker of gut barriers) between LpD3.5 and placebo groups (At baseline (pre), 60 days post intervention and 180 days post intervention)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | University of South Florida |
| Enrollment | 15 (estimated) |
| Start date | 2025-06-15 |
| Primary completion (est.) | 2025-12-15 |
| First posted | 2025-06-12 |
| Last updated | 2025-06-12 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07017959 |
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 - Placebo (Dietary Supplement)
Placebo capsules contain only inactive ingredient maltodextrin
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of South Florida | Tampa, Florida | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.