Probiotics for Health Promotion
(VSS2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different probiotic formulas travel from the stomach to the vagina to better understand their potential health benefits. Participants will try one of three probiotic formulas—Probiotic Formula 1, Probiotic Formula 2, or Probiotic Formula 3—to assess how effectively they reach the vaginal area. The study seeks healthy women aged 18 to 50 with regular menstrual cycles and bowel movements, who are willing to stop using probiotics and fiber supplements before and during the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important health advancements.
Will I have to stop taking my current medications?
The trial requires you to stop taking probiotic supplements and fiber supplements two weeks before and during the study. It doesn't specify other medications, so you may not need to stop them, but it's best to check with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that probiotics are usually safe for people, but they can have some side effects.
For Probiotic Formula 1, avoid using it for more than two days for antibiotic-related diarrhea unless a doctor approves. Prolonged use without medical advice can be risky if a high fever is present.
Probiotic Formula 2 carries more warnings. Some reports indicate it can irritate eyes and skin, so handle it carefully to prevent these issues.
Probiotic Formula 3 also has safety notes. It might cause mild skin irritation and should be used cautiously if symptoms like fever or severe stomach pain occur. Consulting a healthcare provider is advisable if these problems arise.
Studies suggest that while probiotics are generally safe, following safety guidelines is important, especially with certain health conditions. Consider consulting a healthcare professional before starting any new supplement.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these probiotic treatments because they offer a natural approach to enhancing gut health, potentially leading to improved overall well-being. Unlike typical treatments that often rely on medications to manage symptoms, these probiotics work by balancing the gut microbiome, which can play a crucial role in digestion and immune function. Each probiotic formula might contain unique strains of beneficial bacteria, allowing for targeted support tailored to different health needs. This innovative approach could offer a gentler alternative to traditional therapies, with fewer side effects and additional health benefits.
What evidence suggests that this trial's probiotic treatments could be effective for health promotion?
Research shows that probiotics can benefit health in various ways. In this trial, participants will receive one of three different probiotic formulas. Studies have found that Probiotic Formula 1 can reduce bloating and stomach pain. Probiotic Formula 2 supports healthy gut bacteria and aids infant growth. Probiotic Formula 3, also known as VSL#3, has helped heal stomach ulcers by improving gut health. Overall, probiotics like these improve digestion and may offer additional health benefits.678910
Are You a Good Fit for This Trial?
This trial is for healthy women interested in health promotion. Specific eligibility criteria are not provided, but typically participants would need to be adults without current health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive orally delivered probiotic strains to study their transit to the vagina
Follow-up
Participants are monitored for the presence of probiotic strains in the vaginal microbiome after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Probiotic Formula 1
- Probiotic Formula 2
- Probiotic Formula 3
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lallemand Health Solutions
Lead Sponsor