Impact of B. Adolescentis iVS-1 Probiotic on Gastrointestinal Outcomes

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.

NCT Number	NCT07408518
Lead Sponsor	Synbiotic Health Collaborators: People Science, Inc.
Conditions	Digestive Disease, Gut Health
Enrollment	92 participants
Start Date	2026-01-20
Primary Completion	2026-07-27 (estimated)
Study Completion	2026-09-23 (estimated)
Updated on ClinicalTrials.gov	2026-04-01