Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07408518
Brief 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.
Detailed Description:
The probiotic strain, Bifidobacterium adolescentis iVS-1, was isolated from a healthy adult after consumption of the prebiotic galactooligosaccharides (GOS). Genome sequencing confirmed the absence of antibiotic resistance and virulence genes in iVS-1. Clinical trials have shown that the strain can improve gut barrier function and reduce symptoms associated with lactose tolerance.
The rationale for the current study is to observe the impact of the iVS-1 probiotic supplement on gastrointestinal symptoms and its effects on various measures of health that can be collected in a home setting. The study team will examine outcomes in a broad age range of adults who have chosen to try the product. The primary objective is to evaluate the impact of the iVS-1 Probiotic study product on gastrointestinal symptoms (i.e., flatulence, bloating, abdominal discomfort). Secondary objectives include evaluating the impact of iVS-1 on daily gastrointestinal symptoms, anxiety (using the Generalized Anxiety Disorder-7 or GAD-7 score), sleep disturbance (using the Insomnia Sleep Index or ISI score), sleep quality, daytime alertness, and stress. The study will also observe the tolerability of the product and explore its impact on gut microbiota composition and function and identify improvements for future participant-centered study designs.
Participants, who must have self-reported moderate to severe gastrointestinal or digestive symptoms, will be randomized to one of two groups: iVS-1 Probiotic Supplement or matching placebo. The Investigators, study team, and participants will be blinded to the group assignment. The study consists of a screening period, randomization and shipping period, a baseline period, a 6-week product/placebo use period, and a 4-week follow-up period. Data will be collected remotely using the Chloe mobile app, which is People Science's web-based data collection platform. Assessments include the Gastrointestinal Symptom Rating Scale (GSRS), GAD-7, and ISI, administered at baseline and at the end of weeks 2, 4, and 6 during the product use period. Daily surveys will collect data on gastrointestinal symptoms, sleep quality, waking alertness, and stress using a 10-point visual analogue scale (VAS). At-home stool collections will be completed during baseline and at the end of the study product/placebo use period (Day 49) to assess changes in gut microbiota.
Study:
NCT07408518
Study Brief:
Protocol Section:
NCT07408518