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
Public ClinicalTrials.gov record NCT07017959. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07017959
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Interventions
- LpD3.5 supplementation. Dietary Supplement
- Placebo Dietary Supplement
Dietary Supplement
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 14, 2025
- Primary completion
- Dec 14, 2025
- Completion
- Dec 29, 2025
- Last update posted
- Jun 11, 2025
2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33612 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07017959, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 11, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07017959 live on ClinicalTrials.gov.