A Direct-to-Consumer, Randomized, Double-blind, Placebo-controlled Study Assessing the Impact of iVS-1 Probiotic Supplement Containing B. Adolescentis on Gastrointestinal Outcomes in Participants With Self-Reported Moderate to Severe Digestive Symptoms
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Synbiotic Health
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Impact on Gastrointestinal Symptoms
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 18-75 years old, inclusive.
- •Has self-reported moderate to severe gastrointestinal or digestive symptoms, such as abdominal pain, bloating, flatulence, constipation, or diarrhea.
- •Has a Gastrointestinal Symptom Rating Scale (GSRS) score between 4-7, not driven primarily by symptoms of reflux (whereby reflux does not make up more than 60% of GSRS total score).
- •Willingness to refrain from taking probiotics or prebiotics during the study period.
- •Interested in understanding more about their gut health and the use probiotic products.
- •If taking any OTC or prescription medications for anxiety (e.g. magnesium, anticholinergics, Buspirone, Tricyclics, MAOIs,) or other class of medication for anxiety, must be on a stable dose for at least 4 weeks prior to randomization and throughout the course of the study.
- •If using any cannabis-containing products, must be on a stable dose regimen for at least 4 weeks prior to randomization and throughout the course of the study.
- •If using any nicotine-containing products, must be on a stable regimen for at least 4 weeks prior to randomization and throughout the course of the study.
- •In good general health at the time of screening (Investigator discretion).
- •Able to read and understand English.
Exclusion Criteria
- •Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- •Currently on a carnivore diet, raw food diet, fruitarian, liquid diet (does not include vegans or vegetarians).
- •Concomitant Therapies:
- •Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
- •Participants currently taking or have taken antibiotics, probiotic, or prebiotic supplements within the past 4 weeks prior to randomization.
- •Participants using immunosuppressive medications, systemic steroids, antifungals or other medications known to significantly impact gastrointestinal function or microbiota.
- •Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- •Participants with a clinical diagnosis of any gastrointestinal illness, including but not limited to:
- •Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
- •Gastroesophageal reflux disease (GERD)
Arms & Interventions
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.
Intervention: Probiotic (Dietary Supplement)
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.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Impact on Gastrointestinal Symptoms
Time Frame: 6 weeks
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.
Secondary Outcomes
- Daily Gastrointestinal Symptoms(6-week)
- Tolerability of Drug(6 weeks)
- Anxiety(6-weeks)
- Sleep Disturbances(6 weeks)
- Sleep Quality(6 weeks)
- Daytime Alertness(6 weeks)
- Stress(6 Week)