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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Synbiotic Health
Study ID
NCT07408518
Status
Active Not Recruiting

Conditions

  • Digestive Disease
  • Gut Health

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Probiotic — DIETARY_SUPPLEMENT
    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 — OTHER
    An inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested.

Study Details

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.

Key Dates

Start date
Jan 20, 2026
Status verified
Mar 2026
Primary completion
Jul 27, 2026
Completion
Sep 23, 2026

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Active
    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 Comparator: Placebo
    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.

Primary Outcome Measure

Impact on Gastrointestinal Symptoms [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
People Science, Inc.Los AngelesCalifornia90045-

Find similar trials in Los Angeles, CA

By research site
People Science, Inc.· Los Angeles, CA

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