Probiotic for Bile Acid Diarrhea

Overseen By John Damianos, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

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

Disqualifiers: Pregnancy, Ileal resection, Diabetes, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3.5 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a specific probiotic, the De Simone formulation, affects bile acid levels in individuals with bile acid malabsorption (BAM). BAM occurs when the body struggles to reabsorb bile acids, often leading to diarrhea. Participants will receive either the probiotic or a placebo to compare effects. Individuals diagnosed with BAM by a doctor and who experience consistently loose stools may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding new treatment options for 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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the De Simone formulation probiotic is generally safe for patients. In earlier studies, participants did not experience negative side effects, indicating no adverse events. This suggests the treatment is safe for humans, at least in those studies. Researchers are studying the probiotic's impact on bile acid levels in people with bile acid diarrhea and remain hopeful about its safety based on these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the De Simone formulation probiotic for bile acid diarrhea because it offers a natural, gut-friendly alternative to traditional treatments like bile acid sequestrants. Unlike these conventional options, which primarily focus on binding bile acids, the probiotic works by enhancing gut microbiota balance, potentially addressing the root cause of the issue. Additionally, probiotics are generally well-tolerated and come with fewer side effects, making them a promising option for those seeking a gentler approach to managing symptoms.

What evidence suggests that the De Simone formulation probiotic might be an effective treatment for bile acid diarrhea?

Research has shown that the De Simone formulation probiotic, which participants in this trial may receive, might help treat Bile Acid Diarrhea. Early results suggest that this probiotic can improve gut health and reduce symptoms for those with this condition. Studies on similar probiotics have demonstrated significant benefits for some symptoms of Irritable Bowel Syndrome (IBS), which relates to digestive issues like Bile Acid Diarrhea. Additionally, evidence indicates that this specific probiotic can alter bile acid levels, which is important for managing the condition. These findings offer hope for its effectiveness in treating Bile Acid Diarrhea. ^{1 2 4 5 6}

Who Is on the Research Team?

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

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• De Simone formulation 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).

How Is the Trial Designed?

Group I: Probiotic Group Experimental Treatment 1 Intervention

Group II: Control Group Placebo Group 1 Intervention

De Simone formulation probiotic is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Visbiome for:

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

Approved in European Union as Vivomixx for:

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

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Probiotics are widely used, with over 20 billion doses taken annually, and are generally considered safe with very few serious side effects reported.

There is a need for standardized criteria to define what qualifies as a 'probiotic' to ensure products meet safety and efficacy standards, especially as new products enter the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and efficacious probiotics: what are they? Reid, G.[2007]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06609148?cond=Bile&viewType=Table&rank=7

Probiotic in Patients With Bile Acid Malabsorption/Diarrhea The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM. Detailed Description. In this placebo- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8529205/

Strain-specific and outcome-specific efficacy of probiotics ... Six single-strain probiotics and three different types of probiotic mixtures showed significant efficacy for at least one IBS outcome measure.

3. withpower.com withpower.com/trial/phase-bile-acid-diarrhea-9-2024-99f07

Probiotic for Bile Acid Diarrhea These findings suggest that the De Simone formulation probiotic might also help with Bile Acid Diarrhea by improving gut function and reducing symptoms. Show ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01765439

The Effect of VSL#3 Probiotic Preparation on the Bile Acid ... The aim of the study is to determine, whether administration of VSL#3 (Original De Simone formulation) probiotic preparation can alter the bile acid ...

5. clinicaltrial.be clinicaltrial.be/en/details/451843?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Probiotic in Patients With Bile Acid Malabsorption/Diarrh... In this placebo-controlled trial, the De Simone combination probiotic formulation will be tested in 12 patients in each treatment arm.

6. visbiome.com visbiome.com/pages/professional-clinical-studies?srsltid=AfmBOopXz5d6SXE3h97X0DdLRiAe3DRna1pKMWqjfEN2kek8lKgKMsEm

Professional Clinical Studies The De Simone Formulation was well tolerated with no adverse events reported in either study. Visbiome restores Bifidobacterium in patients who are on the low ...