Probiotics for Small Intestinal Bacterial Overgrowth

Overseen By Isaac Wong, MBT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nimble Science Ltd.

Must not be taking: Opioids, Prokinetics, Anticholinergics, others

Disqualifiers: Gastrointestinal disease, Cancer, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

105 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to test the effect of a probiotic formulation on gastrointestinal symptoms, gut and small intestine microbiota in participants suffering from small intestinal bacterial overgrowth (SIBO). Two doses of probiotic will be evaluated against placebo.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must avoid certain drugs that affect gut function a week before the study. If you're on proton pump inhibitors (PPIs), you'll need a 48-hour break before taking the study capsules.

What data supports the effectiveness of the treatment Probiotic, Beneficial bacteria, Live cultures, Microbial supplements for Small Intestinal Bacterial Overgrowth?

Research shows that probiotics can help reduce the overgrowth of bacteria in the small intestine, with a study finding a 62.8% success rate in clearing the condition. Probiotics are also known to improve gut health by competing with harmful bacteria and boosting the immune system. ^{1 2 3 4 5}

Are probiotics safe for human use?

Probiotics are generally considered safe for most people, with a long history of use and few serious side effects reported. However, there are potential risks, especially for vulnerable groups like infants, the elderly, and those with weakened immune systems, so more research is needed to fully understand their safety. ^{6 7 8 9 10}

How is the probiotic treatment for Small Intestinal Bacterial Overgrowth different from other treatments?

Probiotics are unique because they use live beneficial bacteria to restore balance in the gut, unlike antibiotics which kill bacteria indiscriminately. This treatment aims to improve gut health by promoting the growth of good bacteria and inhibiting harmful ones, potentially offering a more natural and less disruptive approach to managing Small Intestinal Bacterial Overgrowth. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for individuals experiencing bloating and abdominal distension due to Small Intestinal Bacterial Overgrowth (SIBO). Participants should be diagnosed with SIBO. The study excludes those who do not meet the specific medical criteria required, which are not detailed here.

Inclusion Criteria

I am between 18 and 55 years old.

Signed Informed Consent; willing and able to comply with study procedures

Participants SIBO-positive as measured with the Glucose Breath Test following the North American Consensus recommendations (A rise in hydrogen of ≥20 p.p.m. by 90 min)

Exclusion Criteria

Persons with central venous catheters

I have a known issue in my digestive system that causes blockages.

I have a diagnosed disorder that affects how my stomach or intestines move food.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two different doses of a probiotic formulation or placebo for 8 weeks

8 weeks

Visits at baseline, mid-intervention (week 4), and end-of-intervention (week 8)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Visit at follow-up (week 12)

Treatment Details

Interventions

• Probiotic

Trial Overview The study tests a probiotic formula against a placebo to see if it can reduce gastrointestinal symptoms like bloating in people with SIBO. It also looks at how this treatment affects the overall gut microbiome using an innovative capsule called SIMBA.

Participant Groups

Group I: Probiotic (Low dose) Experimental Treatment 1 Intervention

A low dosage probiotic per capsule

Group II: Probiotic (High dose) Experimental Treatment 1 Intervention

A high dosage probiotic per capsule

Group III: Control group (Placebo) Active Control 1 Intervention

No probiotic dosage

Probiotic is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Approved in United States as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Approved in Canada as Probiotics for:

• Supports gut health
• Reduces symptoms of irritable bowel syndrome (IBS)
• Supports immune system

Who Is Running the Clinical Trial?

Nimble Science Ltd.

Lead Sponsor

Trials

11

Recruited

570+

Lallemand Health Solutions

Industry Sponsor

Trials

44

Recruited

4,100+

Founded

1934

Headquarters

Mirabel, Canada

Known For

Microbiome therapies

Top Products

Lacidofil, ProbioKid, Probio'Stick, IBacilluS+

Findings from Research

Probiotics were found to significantly improve the decontamination rate of small intestinal bacterial overgrowth (SIBO), with a rate of 62.8% compared to nonprobiotic groups, indicating their efficacy in treating this condition.

While probiotics effectively reduced hydrogen (H2) concentration and alleviated abdominal pain, they did not show significant effectiveness in preventing SIBO or reducing daily stool frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics for Preventing and Treating Small Intestinal Bacterial Overgrowth: A Meta-Analysis and Systematic Review of Current Evidence. Zhong, C., Qu, C., Wang, B., et al.[2022]

In a pilot study of 30 patients with small intestinal bacterial overgrowth (SIBO), those who received a lactobacilli probiotic (lactol) alongside maintenance antibiotic therapy showed a significant improvement, with 93.3% testing negative on the hydrogen breath test compared to 66.7% in the control group.

Patients taking lactol experienced complete relief from abdominal pain and significant improvements in other gastrointestinal symptoms like flatulence and diarrhea, suggesting that probiotics may enhance the effectiveness of antibiotic treatment for SIBO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of probiotic on treatment in patients with small intestinal bacterial overgrowth (SIBO)--a pilot study. Khalighi, AR., Khalighi, MR., Behdani, R., et al.[2018]

Probiotic therapy, which involves using live non-pathogenic bacteria, shows promise in treating and preventing gastrointestinal disorders such as inflammatory bowel disease and antibiotic-related diarrhea, highlighting its potential efficacy in restoring gut health.

The therapeutic effects of probiotics may stem from their ability to compete with harmful pathogens, produce antimicrobial substances, and modulate immune functions, but further controlled clinical trials are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics: an emerging therapy. O'Sullivan, GC., Kelly, P., O'Halloran, S., et al.[2019]

Testing for small intestinal bacterial overgrowth (SIBO) can provide significant relief for patients, but it should be done carefully to avoid unnecessary procedures and anxiety about food choices.

Effective management of SIBO involves using breath test results alongside patient history and symptoms to guide treatment, rather than relying solely on lab results or unvalidated recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is SIBO A Real Condition? Ruscio, M.[2022]

Small intestinal bacterial overgrowth (SIBO) is frequently seen in patients with intestinal failure and can lead to symptoms, mucosal injury, and malnutrition due to changes in intestinal anatomy and motility.

While antibiotic therapy is the main treatment for SIBO, the potential benefits of probiotics in enhancing gut barrier function and reducing inflammation need further investigation in human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small intestinal bacterial overgrowth: roles of antibiotics, prebiotics, and probiotics. Quigley, EM., Quera, R.[2022]

Probiotics have a long history of safe use, and while clinical trials generally show no increased risk, the current literature lacks comprehensive safety reporting, making it difficult to draw definitive conclusions about their safety in intervention studies.

Theoretical risks associated with probiotics include systemic infections and gastrointestinal side effects, highlighting the need for further research to accurately assess the incidence and severity of any adverse events related to their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of probiotics. Doron, S., Snydman, DR.[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]

Probiotics can have both benefits and potential adverse effects, especially as their use expands into vulnerable populations, highlighting the need for careful monitoring and recommendations for safe use.

The International Scientific Association for Probiotics and Prebiotics emphasizes the importance of whole genome sequencing to assess the safety of probiotic strains, including their virulence and antibiotic resistance, to ensure product quality and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging issues in probiotic safety: 2023 perspectives. Merenstein, D., Pot, B., Leyer, G., et al.[2023]

Probiotics, while generally considered safe, can pose significant risks including systemic infections, gastrointestinal issues, and immune system stimulation, particularly in vulnerable populations such as infants, the elderly, and immunocompromised individuals.

The review highlights the need for careful evaluation of the risk-benefit ratio of probiotics before recommending their use, given the variety of adverse effects reported across different studies and case reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reappraisal of probiotics' safety in human. Sotoudegan, F., Daniali, M., Hassani, S., et al.[2019]

Probiotics, which are live microorganisms that can positively alter gut microflora, have been shown to be effective in treating and preventing various gastrointestinal and non-gastrointestinal diseases, including respiratory infections and hypercholesterolemia.

Probiotic supplements are generally considered safe, as they contain microorganisms similar to those naturally found in the human body, highlighting their potential for beneficial health effects when consumed appropriately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics in clinical practice: an overview. Zuccotti, GV., Meneghin, F., Raimondi, C., et al.[2019]

The study identified two strains, Candida famata and Geobacillus thermoleovorans, from pure oil waste that exhibit probiotic properties, including antimicrobial activity against pathogenic bacteria.

Geobacillus thermoleovorans showed the ability to produce biofilm and adhere to surfaces, while Candida famata did not produce biofilm but expressed various enzymes, suggesting both strains could be potential candidates for probiotic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary characterization of the probiotic properties of Candida famata and Geobacillus thermoleovorans. Mahdhi, A., Hmila, Z., Behi, A., et al.[2021]

Probiotics, particularly strains like Lactobacillus and Bifidobacterium, have been shown to effectively prevent and treat various gastrointestinal disorders, including antibiotic-associated diarrhea and inflammatory bowel disease, based on recent clinical studies.

They work through multiple mechanisms, such as enhancing immune response and inhibiting harmful bacteria, making them a promising option for improving intestinal health, although further research is needed to fully understand their role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of probiotic cultures in the control of gastrointestinal health. Rolfe, RD.[2022]

Probiotic supplementation after antibiotic therapy helps maintain a healthier gut microbiota by promoting the growth of beneficial bacteria like bacteroides, while the placebo group showed an increase in potentially harmful bacteria.

The study found that patients taking probiotics did not experience an increase in antibiotic-resistant enterococci, unlike those in the placebo group, suggesting that probiotics may help prevent the development of antibiotic resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of probiotics on the composition of the intestinal microbiota following antibiotic therapy. Plummer, SF., Garaiova, I., Sarvotham, T., et al.[2006]

Probiotics have the potential to improve gut health in critically ill patients by reducing harmful pathogens and supporting immune function, but current strains and doses may not provide immediate benefits and require long-term use for effectiveness.

There is still a lack of conclusive evidence regarding the safety and optimal use of probiotics in critically ill patients, particularly concerning their risk of causing infections, which means they cannot be routinely recommended at this time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic use in the critically ill. Singhi, SC., Baranwal, A.[2021]

References

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

Probiotics for Preventing and Treating Small Intestinal Bacterial Overgrowth: A Meta-Analysis and Systematic Review of Current Evidence. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of probiotic on treatment in patients with small intestinal bacterial overgrowth (SIBO)--a pilot study. [2018]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Probiotics: an emerging therapy. [2019]

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

Is SIBO A Real Condition? [2022]

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

Small intestinal bacterial overgrowth: roles of antibiotics, prebiotics, and probiotics. [2022]

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

Risk and safety of probiotics. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Emerging issues in probiotic safety: 2023 perspectives. [2023]

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

Reappraisal of probiotics' safety in human. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Probiotics in clinical practice: an overview. [2019]

11. Iran pubmed.ncbi.nlm.nih.gov

Preliminary characterization of the probiotic properties of Candida famata and Geobacillus thermoleovorans. [2021]

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

The role of probiotic cultures in the control of gastrointestinal health. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of probiotics on the composition of the intestinal microbiota following antibiotic therapy. [2006]

14. India pubmed.ncbi.nlm.nih.gov

Probiotic use in the critically ill. [2021]