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

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

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.

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.

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.
• Able to read, understand, and provide informed consent.
• Able to use a personal smartphone device and download Chloe by People Science.
• Able to receive shipment of the product at an address within the United States.
• Able to complete study assessments over the course of up to 17 weeks.

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:

  1. Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
  2. Participants currently taking or have taken antibiotics, probiotic, or prebiotic supplements within the past 4 weeks prior to randomization.
  3. 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:

  1. 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)
     • Gastric or duodenal ulcers
     • Celiac disease
     • Diverticular disease
     • Chronic pancreatitis
     • Gastroparesis
     • Severe liver disease (e.g., cirrhosis, hepatitis, NAFLD acceptable)
     • Gallbladder disease (e.g., cholecystitis, cholelithiasis)
     • Gastrointestinal cancer (Colorectal, Intestinal, Stomach, Liver, Gallbladder)

  2. Participants with a known or suspected gastrointestinal infection, such as:

     • Clostridium difficile infection
     • Helicobacter pylori infection
     • Parasitic infections (e.g., Giardia, Cryptosporidium)

  3. Participants with a history of gastrointestinal surgery, excluding appendectomy and cholecystectomy.

  4. Participants with a history of gastrointestinal bleeding or perforation.

  5. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.

  6. Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding.

  7. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.

  8. Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.

• Known hypersensitivity or previous allergic reaction to Bifidobacterium adolescentis, microcrystalline cellulose, the capsule material (hydroxypropylmethylcellulose), magnesium stearate and silicon dioxide.

• Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.