Probiotic for Bile Acid Diarrhea

Recruiting in Palo Alto (17 mi)

Overseen by Michael Camilleri, M.D., D.Sc.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must not be taking: Antibiotics, Probiotics, Bile acid sequestrants

Disqualifiers: Pregnancy, Ileal resection, Diabetes, others

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.

Will I have to stop taking my current medications?

If you are taking bile acid sequestrants, you will need to stop them 10 days before starting the 7-day stool diary and for the duration of the study. Also, you should not have used oral antibiotics or probiotics in the last 4 weeks before joining the trial.

What data supports the effectiveness of the treatment De Simone formulation probiotic for Bile Acid Diarrhea?

Research on similar probiotics, like VSL#3 and Visbiome, shows they can improve gut health and symptoms in conditions with diarrhea, such as irritable bowel syndrome and in people with HIV. These findings suggest that the De Simone formulation probiotic might also help with Bile Acid Diarrhea by improving gut function and reducing symptoms. ^{1 2 3 4 5}

Is the probiotic treatment safe for humans?

Probiotics like Visbiome and VSL#3® are generally considered safe for humans, with serious side effects being rare. Studies have shown that they are well tolerated in various clinical settings, including in people with HIV and other gastrointestinal conditions. ^{3 5 6 7 8}

How is the De Simone formulation probiotic treatment different from other treatments for bile acid diarrhea?

The De Simone formulation probiotic is unique because it is a high concentration multistrain probiotic that has shown benefits in improving gut health and immune function in other conditions, such as HIV, by enhancing intestinal barrier integrity and reducing inflammation, which may offer a novel approach for managing bile acid diarrhea. ^{1 2 4 5 9}

Research Team

Michael Camilleri, M.D., D.Sc.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with Bile Acid Malabsorption (BAM) or chronic diarrhea linked to bile acid issues. Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis and meet certain health standards.

Inclusion Criteria

I have a documented history of bile acid malabsorption.

My average stool consistency is loose, as per the Bristol Scale.

I am not pregnant and agree to use birth control during the study.

Exclusion Criteria

I have not taken oral antibiotics or probiotics in the last 4 weeks.

I have had surgery to remove part of my ileum.

I have been diagnosed with an inflammatory gastrointestinal disease or had a GI infection in the last 4 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DSF probiotic or placebo for 24 days to assess effects on fecal bile acid levels

3.5 weeks

Baseline visit, followed by regular monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• De Simone formulation probiotic (Probiotic)

Trial Overview The study is testing the effects of a probiotic called De Simone formulation (DSF) on fecal bile acid levels in patients with BAM, compared to a placebo (a substance with no active therapeutic effect).

Participant Groups

Group I: Probiotic Group Experimental Treatment 1 Intervention

Group II: Control Group Placebo Group 1 Intervention

De Simone formulation probiotic is already approved in Canada for the following indications:

Approved in Canada as Visbiome for:

• Irritable Bowel Syndrome (IBS)
• Inflammatory Bowel Disease (IBD)
• Pouchitis

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Findings from Research

In a study involving 25 patients with diarrhea-predominant irritable bowel syndrome, the probiotic formulation VSL#3 significantly reduced abdominal bloating compared to placebo, indicating its potential benefit for this specific symptom.

However, VSL#3 did not show significant effects on overall gastrointestinal transit, bowel function scores, or other symptoms like abdominal pain and urgency, suggesting its efficacy may be limited to bloating relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. Kim, HJ., Camilleri, M., McKinzie, S., et al.[2022]

In a randomized, double-blind, placebo-controlled study involving healthy adults, daily consumption of the probiotic combination SYNBIO® significantly improved bowel habits compared to the control group.

The study also confirmed that the probiotic strains persisted in the gastrointestinal tract, indicating their potential for long-term benefits in bowel health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic-enriched foods and dietary supplement containing SYNBIO positively affects bowel habits in healthy adults: an assessment using standard statistical analysis and Support Vector Machines. Silvi, S., Verdenelli, MC., Cecchini, C., et al.[2022]

In a 24-week phase II study involving 93 participants, Visbiome Extra Strength was found to be safe and well tolerated, with no significant adverse effects reported.

While Visbiome ES altered the microbiome by increasing probiotic species and decreasing Gammaproteobacteria, it did not show any significant effects on systemic inflammation or gut permeability in individuals undergoing antiretroviral therapy for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Placebo-Controlled Trial Assessing the Effect of VISBIOME ES Probiotic in People With HIV on Antiretroviral Therapy. Presti, RM., Yeh, E., Williams, B., et al.[2022]

A randomized trial showed that a novel synbiotic drink, containing bifidobacteria and Fucus evanescens polysaccharides, significantly improved symptoms and recovery of intestinal microflora in patients with chronic gastrointestinal diseases compared to standard treatments.

Patients receiving the synbiotic drink had a higher cure rate than those undergoing routine therapy or treatment with sour milk bifidobacterin, indicating its potential as an effective therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency of a new synbiotic drink in treatment of chronic diseases of gastrointestinal tract and concomitant dysbacteriosis]. Kuznetsova, TA., Zaporozhets, TS., Besedova, NN., et al.[2016]

The synbiotic beverage, which combines fructooligosaccharides and Lactobacillus casei Lc-01, significantly improved the growth of beneficial bacteria like Lactobacillus and Bifidobacterium while reducing harmful bacteria in the ascending colon, based on a study using the SHIME® model.

Treatment with the synbiotic beverage also led to a notable reduction in ammonia ions in the ascending colon, indicating a positive effect on microbial metabolism, although no significant differences were found in short-chain fatty acid production among the different beverage formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of fermented vegetal beverages on human gastrointestinal microbial ecosystem in a simulator. Bianchi, F., Rossi, EA., Sakamoto, IK., et al.[2019]

In a study of 54 patients with irritable bowel syndrome (IBS) and antibiotic-associated diarrhea (AAD), the probiotic supplement Neobiotic Lactobalance® significantly reduced symptoms of diarrhea and abdominal pain, with symptom scores decreasing by up to 4.3 times after 21 days of treatment.

The intake of Neobiotic Lactobalance® also normalized the intestinal microbiota, increasing beneficial bacteria levels, which suggests its efficacy in restoring gut health in patients with dysbiosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of a modern probiotic for the correction of intestinal microflora in patients with irritable bowel syndrome with diarrhea and antibiotic-associated diarrhea]. Drozdov, VN., Shikh, EV., Astapovskii, AA., et al.[2023]

In a review of three double-blind, randomized, placebo-controlled trials involving 120 patients, VSL#3® was found to be safe and well-tolerated, with no significant difference in adverse events compared to placebo.

Out of the patients analyzed, 64.1% in the VSL#3® group and 64.5% in the placebo group reported at least one adverse event, indicating that the probiotic does not increase the risk of adverse effects compared to a placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety profile of probiotic VSL#3®. A meta-analysis of safety data from double-blind, randomized, placebo-controlled clinical trials. Panetta, V., Bacchieri, A., Papetti, S., et al.[2022]

In a study involving HIV-1 patients on antiretroviral therapy, a high concentration multistrain probiotic was taken twice daily for 6 months, leading to a reduction in activated T-cell subsets and an increase in beneficial Th17 cells, indicating improved immune regulation.

Probiotic supplementation also helped restore gut barrier integrity, reduce enterocyte apoptosis, and improve mitochondrial health, suggesting it may enhance both physical and immunological aspects of gut health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic supplementation promotes a reduction in T-cell activation, an increase in Th17 frequencies, and a recovery of intestinal epithelium integrity and mitochondrial morphology in ART-treated HIV-1-positive patients. d'Ettorre, G., Rossi, G., Scagnolari, C., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Probiotic-enriched foods and dietary supplement containing SYNBIO positively affects bowel habits in healthy adults: an assessment using standard statistical analysis and Support Vector Machines. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Placebo-Controlled Trial Assessing the Effect of VISBIOME ES Probiotic in People With HIV on Antiretroviral Therapy. [2022]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Efficiency of a new synbiotic drink in treatment of chronic diseases of gastrointestinal tract and concomitant dysbacteriosis]. [2016]

5. Canada pubmed.ncbi.nlm.nih.gov

Beneficial effects of fermented vegetal beverages on human gastrointestinal microbial ecosystem in a simulator. [2019]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of a modern probiotic for the correction of intestinal microflora in patients with irritable bowel syndrome with diarrhea and antibiotic-associated diarrhea]. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

The safety profile of probiotic VSL#3®. A meta-analysis of safety data from double-blind, randomized, placebo-controlled clinical trials. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safe and efficacious probiotics: what are they? [2007]

9. England pubmed.ncbi.nlm.nih.gov

Probiotic supplementation promotes a reduction in T-cell activation, an increase in Th17 frequencies, and a recovery of intestinal epithelium integrity and mitochondrial morphology in ART-treated HIV-1-positive patients. [2022]