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Impact of B. Adolescentis iVS-1 Probiotic on Gastrointestinal Outcomes
Sponsor: Synbiotic Health
Summary
The study team is conducting a consumer-driven, decentralized clinical research study to assess the impact of the consumer-grade probiotic supplement, iVS-1, on adults with moderate to severe gastrointestinal discomfort. Bifidobacterium adolescentis iVS-1 was chosen for its association with gastrointestinal health benefits and its safety profile, having been self-affirmed as GRAS and lacking antibiotic resistance and virulence genes. The study aims to evaluate the probiotic's effects not only on gastrointestinal symptoms but also on secondary outcomes like sleep disturbance, sleep quality, daytime alertness, anxiety, stress, and gut microbiota. This will be accomplished using self-reported outcome questionnaires, daily surveys, and at-home stool collection over a period of up to 17 weeks. There is no "doctor-patient" relationship, as participants are making an informed choice to take the product as consumers and participate in the process. Findings will contribute to knowledge about the probiotic's tolerability, formulation, and the design of future studies.
Official title: A Direct-to-Consumer, Randomized, Double-blind, Placebo-controlled Study Assessing the Impact of iVS-1 Probiotic Supplement Containing B. Adolescentis on Gastrointestinal Outcomes in Participants With Self-Reported Moderate to Severe Digestive Symptoms
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2026-01-20
Completion Date
2026-09-23
Last Updated
2026-04-01
Healthy Volunteers
Yes
Conditions
Interventions
Probiotic
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.
Placebo
An inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested.
Locations (1)
People Science, Inc.
Los Angeles, California, United States