LpD3.5 Supplementation for Inflammatory Bowel Disease

(LIBD Trial)

Overseen By Shalini Jain, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must not be taking: Intravenous corticosteroids, Microbiome-influencing drugs

Disqualifiers: Severe GI surgery, Cancer, Heart disease, others

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the probiotic supplement Lactobacillus Paracasei D3.5 (LpD3.5) can improve gut health in individuals with inflammatory bowel disease (IBD). Researchers examine how this supplement impacts the gut's protective barriers and overall inflammation. Participants will take either the supplement or a placebo for 60 days, then switch after a break period. Ideal candidates have a confirmed IBD diagnosis for more than three months, experience mild to moderate symptoms, and have undergone a colonoscopy within the last two years. As an unphased trial, this study offers an opportunity to contribute to groundbreaking research that could enhance future IBD treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use other probiotics, prebiotics, or similar supplements during the study. If you are using these, you must stop at least 30 days before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Lactobacillus Paracasei D3.5 (LpD3.5), a type of heat-inactivated probiotic, is considered safe by the FDA, indicating its general acceptance for use. In another study, a similar product called PoZibio®, containing LpD3.5, was tested on 13 people and was well-tolerated, with no serious side effects reported. This suggests that LpD3.5 is likely safe for humans, with no major negative effects known so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for inflammatory bowel disease, which often include anti-inflammatory drugs, immunosuppressants, and biologics, LpD3.5 supplementation offers a unique approach by using a specific strain of probiotic, Lactobacillus Paracasei D3.5. This probiotic is believed to help balance gut bacteria, potentially reducing inflammation naturally without the side effects commonly associated with pharmaceuticals. Researchers are excited about LpD3.5 because it represents a natural and potentially safer alternative that could complement or even reduce the need for conventional medications.

What evidence suggests that LpD3.5 might be an effective treatment for IBD?

Research has shown that Lactobacillus paracasei, the probiotic in LpD3.5, might help reduce gut inflammation. Studies suggest that probiotics like this can support the immune system, potentially easing symptoms of conditions such as inflammatory bowel disease (IBD). Some research indicates that these probiotics can boost levels of mucin, a protein that strengthens the gut lining and reduces its leakiness. By improving these gut barriers, LpD3.5 might help protect the intestines and lower inflammation. Although more research is needed, early results are promising for its potential in managing IBD symptoms. Participants in this trial will receive either LpD3.5 supplementation or a placebo to evaluate its effectiveness. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with Inflammatory Bowel Disease (IBD). Participants will be given dietary supplement capsules and must consent to provide stool and blood samples. They should be willing to follow the study's procedures, including a washout period and crossover into opposite treatment arms.

Inclusion Criteria

Body mass index (BMI) between 18 and 40 kg/m²

I am 18 years old or older.

Last colonoscopy within 2 years of study entry

Exclusion Criteria

I have had major surgery on my digestive system.

I was diagnosed with cancer or treated with chemotherapy/radiation in the last 2 years.

I have not had antibiotics, diarrhea, or vomiting in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or LpD3.5 supplementation for 60 days

8 weeks

3 visits (in-person) at baseline, 30 days, and 60 days

Washout

A 60-day washout period before crossover to the opposite arm

8 weeks

Crossover Treatment

Participants switch to the opposite arm and receive the alternate supplementation for 60 days

8 weeks

2 visits (in-person) at 30 days and 60 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lactobacillus Paracasei D3.5 (LpD3.5)

Trial Overview The trial tests the effects of LpD3.5, a heat inactivated probiotic, on gut mucin levels and intestinal permeability compared to a placebo. It's a small pilot study where participants take either the probiotic or placebo for 60 days, have a break, then switch treatments.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 Intervention

LpD3.5 supplementation.

Group II: Placebo Comparator Placebo Group 1 Intervention

Placebo supplementation.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07017959

Impact of a Human Origin Heat Inactivated Probiotic ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3145352/

Lactobacillus paracasei Reduces Intestinal Inflammation in ... We conclude that probiotics such as Lactobacillus paracasei harbor worthwhile in vivo immunomodulatory properties to prevent intestinal inflammation by ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07017959?lead=tampa%20general%20hospital%20OR%20University%20of%20South%20Florida&sort=StudyFirstPostDate&viewType=Table&keyword=cancer%252520institute&rank=3

Impact of a Human Origin Heat Inactivated Probiotic ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0944501322000593

Lactobacillus and intestinal diseases: Mechanisms of ... Lactobacillus's applications in common intestinal disorders including the Helicobacter pylori infection, colorectal cancer, diarrhea, inflammatory bowel ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/fsn3.70034

The Analysis and Comparison of Anti‐Inflammatory and ... The objective of this study was to investigate the ability of postbiotic and paraprobiotic substances to regulate oxidative stress and inflammation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11692762/

SAFETY AND EFFECTS OF HEAT-INACTIVATED ... In this open-label pilot study, we tested PoZibio®, a postbiotic containing heat-inactivated Lactobacillus paracasei D3.5 (LpD3.5), in 13 ...

7. mdpi.com mdpi.com/2218-273X/15/7/954

Postbiotics as Mitochondrial Modulators in Inflammatory ... Postbiotics such as SCFAs, butyrate, and heat-inactivated Lactobacillus paracasei (D3-5) ameliorates leaky gut, inflammation and improves physical and cognitive ...