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LpD3.5 Probiotic Supplement for Inflammatory Bowel Disease

This study is looking at how a dietary supplement called LpD3.5, which is a heat-treated probiotic, might help adults with Inflammatory Bowel Diseases (IBD). Researchers want to see if LpD3.5 can improve the gut's protective lining (mucin barriers) and reduce how easily things pass through the intestine (intestinal permeability). You might be able to join if you are 18 or older, have a confirmed IBD diagnosis for over 3 months with mild to moderate symptoms, and a BMI between 18 and 40. The main way they will measure success is by checking the levels of mucin in your stool after taking either LpD3.5 or a placebo. The current status of this study is unclear.

Study design
This is a small, randomized, placebo-controlled pilot study planning for 15 participants with IBD. Participants will be assigned to either receive LpD3.5 or a placebo.
What's involved
Participants will take two capsules daily for 60 days. Fecal mucin levels will be measured at the start, after 60 days, and again after 180 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 180 days after the intervention to measure fecal mucin levels.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07017959

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 Yet Recruiting
NAAges 18+InterventionalScreening
University of South Florida
~15 participants
Updated 2025-06-12 on ClinicalTrials.gov
What's tested:LpD3.5 supplementation.Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Levels of post-intervention fecal mucin (marker of gut barriers) between LpD3.5 and placebo groups
Measured over At baseline (pre), 60 days post intervention and 180 days post intervention

Conditions

Inflammatory Bowel Diseases

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Where it's being run

1 sites across 1 states
Florida1

Who to contact

Shalini Jain, PhD
[email protected]
813-974-6281
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Levels of post-intervention fecal mucin (marker of gut barriers) between LpD3.5 and placebo groupsAt baseline (pre), 60 days post intervention and 180 days post intervention

    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).