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

NCT07408518 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Digestive Disease
  • Gut Health

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

Placebo

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

Sponsors & Collaborators

  • People Science, Inc.

    collaborator INDUSTRY

  • Synbiotic Health

    lead INDUSTRY

Principal Investigators

  • Noah Craft, MD · People Science, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2026-07-27
Completion
2026-09-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07408518 on ClinicalTrials.gov