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NCT07017959 · ClinicalTrials.gov registry record · NA
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
A NA study, sponsored by University of South Florida.
- Not yet
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT07017959: Clinical Trial NA study, sponsored by University of South Florida.
NCT07017959 is a NA study that has not yet begun recruiting, run by University of South Florida. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07017959, a NA study, has not yet begun recruiting, sponsored by University of South Florida.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT LpD3.5 supplementation.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-06-15 |
| Est. Completion | 2025-12-30 |
| Phase | NA |
What is known before NCT07017959 opens enrollment
NCT07017959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07017959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07017959 about?
NCT07017959 is a clinical study titled "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". 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 ...
What is the current status of trial NCT07017959?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-06-15. Estimated completion is 2025-12-30.
What interventions are being tested in trial NCT07017959?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), LpD3.5 supplementation. (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07017959?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07017959's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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