Probiotic for Gut Health
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the probiotic supplement Bifidobacterium adolescentis iVS-1 can improve gut health and alleviate moderate to severe digestive issues such as bloating, abdominal pain, and gas. Researchers aim to determine if the probiotic can also enhance sleep and reduce anxiety. Participants will be divided into two groups: one receiving the probiotic and the other a placebo (a pill with no active ingredient), without knowing which one they are taking. This trial suits those with ongoing digestive problems who are interested in exploring probiotics for relief. Participants must be willing to use a smartphone app and complete surveys over 17 weeks. As an unphased trial, this study provides a unique opportunity to explore the potential benefits of probiotics for digestive health and overall well-being.
Will I have to stop taking my current medications?
You don't have to stop your current medications, but if you're taking anxiety medications, cannabis, or nicotine products, you need to be on a stable dose for at least 4 weeks before and during the study. You must avoid taking probiotics or prebiotics during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that Bifidobacterium adolescentis iVS-1 is generally safe for humans. Known for its benefits to gut health, this probiotic does not carry antibiotic resistance or harmful genes. Experts consider it safe based on scientific evidence, and it is classified as GRAS (Generally Recognized as Safe).
Research also suggests that this probiotic can aid in better digestion and improved sleep. Its safety record is strong, with no major side effects reported in studies. Participants in past research tolerated the probiotic well, indicating its safety for human use.12345Why are researchers excited about this trial?
Unlike the standard gut health treatments, which often involve dietary changes and medications, Bifidobacterium adolescentis iVS-1 is a probiotic supplement specifically targeting gut health. This treatment is unique because it introduces a beneficial bacterium directly into the gut, potentially enhancing the balance of gut flora more effectively than traditional methods. Researchers are excited about this probiotic because it offers a natural and potentially more sustainable approach to improving gut health, which could lead to better overall digestive wellness without the side effects associated with some pharmaceuticals.
What evidence suggests that this trial's treatments could be effective for gastrointestinal discomfort?
Research has shown that Bifidobacterium adolescentis iVS-1 can improve gut health. In one study, participants who took this probiotic for two weeks experienced reduced symptoms such as diarrhea and urgency. It also improved lactose digestion. Another study found that it relieved constipation by balancing gut bacteria. Participants taking iVS-1 reported fewer daily symptoms compared to those on a placebo. These findings suggest that iVS-1 may ease stomach and digestive discomfort. In this trial, participants will be randomized to receive either the iVS-1 Probiotic Supplement or a matching placebo to further evaluate its effectiveness.16789
Who Is on the Research Team?
Noah Craft, MD
Principal Investigator
People Science, Inc.
Are You a Good Fit for This Trial?
Adults aged 18-75 with moderate to severe gastrointestinal discomfort, who are interested in their gut health and willing to avoid other probiotics or prebiotics during the study. Participants should have stable medication use if taking anxiety meds, cannabis products, or nicotine.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Shipping
Participants are randomized to either the iVS-1 Probiotic Supplement or placebo group, and products are shipped to participants
Baseline
Baseline assessments are conducted using self-reported outcome questionnaires and at-home stool collection
Treatment
Participants receive the study product or placebo for 6 weeks, with assessments at baseline and at the end of weeks 2, 4, and 6
Follow-up
Participants are monitored for safety and effectiveness after treatment, including at-home stool collection
What Are the Treatments Tested in This Trial?
Interventions
- Bifidobacterium adolescentis iVS-1
Trial Overview
The trial is testing a consumer-grade probiotic supplement called B. Adolescentis iVS-1 against a placebo to see its effects on gastrointestinal symptoms and related outcomes like sleep and stress over up to 17 weeks using questionnaires and stool samples.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Participants will be randomized to one of two groups A or B: (1) IVS-1 Probiotic Supplement, and (2) Matching placebo. The Investigators, the study team and participants will be blinded to the group assignment.
Participants will be randomized to one of two groups A or B: (1) IVS-1 Probiotic Supplement, and (2) Matching placebo. The Investigators, the study team and participants will be blinded to the group assignment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Synbiotic Health
Lead Sponsor
People Science, Inc.
Industry Sponsor
Citations
NCT07408518 | Impact of B. Adolescentis iVS-1 Probiotic ...
The study aims to evaluate the probiotic's effects not only on gastrointestinal symptoms but also on secondary outcomes like sleep disturbance, ...
Two-week supplementation of Bifidobacterium ...
Two-week supplementation of Bifidobacterium adolescentis iVS-1 reduces fecal urgency and diarrhea and enhances overall lactose tolerance in lactose ...
Bifidobacterium adolescentis Strengthens Gut Barrier in Post ...
Current evidence demonstrates that Bifidobacterium alleviates functional constipation through modulation of gut microbiota and enhancement of ...
Two-week supplementation of Bifidobacterium ...
The iVS-1 group reported less overall daily symptoms during the treatment period when compared to placebo (p = 0.032) and had significant improvement for fecal ...
Probiotic for Gut Health
The trial is testing a consumer-grade probiotic supplement called B. Adolescentis iVS-1 against a placebo to see its effects on gastrointestinal ...
Experience Healthy Aging with B. adolescentis
iVS-1® excels in GABA production, which can provide a range of health benefits related to cognitive function, pain management, sleep quality and gut health.
Genome analysis of Bifidobacterium adolescentis and ... - PMC
Genome analysis of Bifidobacterium adolescentis and investigation of its effects on inflammation and intestinal barrier function
A Bifido Bacteria to Improve Lactose Digestion and Tolerance
Bifidobacterium adolescentis IVS-1 presents a unique opportunity to evaluate both species and dose of a very well characterized probiotic in ...
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