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NCT07408518 · ClinicalTrials.gov registry record · NA
Impact of B. Adolescentis iVS-1 Probiotic on Gastrointestinal Outcomes
A NA study of Gut Health and Digestive Disease, sponsored by Synbiotic Health.
- Recruiting
- Registry status
- NA
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT07408518: Recruiting NA study of Gut Health and Digestive Disease, sponsored by Synbiotic Health.
NCT07408518 is a NA study of Gut Health and Digestive Disease that is actively recruiting participants, run by Synbiotic Health. The registered enrollment target is 92 participants, above the 52-participant average among 9 other Gut Health trials with a reported enrollment target (77% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07408518, a NA study of Gut Health and Digestive Disease, is actively recruiting participants, sponsored by Synbiotic Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary objective of this study is to evaluate the impact of the iVS-1 Probiotic study product on gastrointestinal symptoms, such as flatulence, bloating, and abdominal discomfort. This goal will be measured by the change in the mean total score on the Gastrointestinal Symptom Rating Scale (GSRS) between the study product and placebo groups during the study period. The study product/placebo use period is 6 weeks. Baseline period will be compared as well.
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Probiotic
Study Locations (1)
California
- People Science, Inc. - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2026-01-20 |
| Est. Completion | 2026-09-23 |
| Phase | NA |
What NCT07408518 shows while recruiting
NCT07408518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 52-participant average among 9 other Gut Health trials with a reported enrollment target (77% higher).
The record links to 2 conditions, with Gut Health appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07408518 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07408518 about?
NCT07408518 is a clinical study titled "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 gastroin...
What is the current status of trial NCT07408518?
This trial is currently recruiting. It is a NA study. The enrollment target is 92 participants. The study started on 2026-01-20. Estimated completion is 2026-09-23.
What conditions does trial NCT07408518 study?
This clinical trial studies the following conditions: Gut Health, Digestive Disease.
What interventions are being tested in trial NCT07408518?
The interventions under investigation include: Placebo (OTHER), Probiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07408518?
This trial is sponsored by Synbiotic Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07408518 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07408518's enrollment target sits among peer trials
92 2nd of 9 the highest of 9 other Gut Health trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gut Health trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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