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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gut Health; Digestive Disease
• Intervention / Treatment: Dietary supplement: Probiotic; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • People Science, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Placebo Comparator: 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.	Other: Placebo; An inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on Gastrointestinal Symptoms	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Gastrointestinal Symptoms	The goal is to evaluate the impact of the iVS-1 Probiotic study product on daily gastrointestinal symptoms (i.e., flatulence, bloating, abdominal discomfort). This will be measured by the change in mean GSRS scores between placebo and study product groups: Scores by individual dimension (diarrhea, indigestion, constipation, abdominal pain and reflux).; Composite scores at Week 2 and Week 4. Baseline period will be compared as well.	6-week
Tolerability of Drug	The goal is to observe the tolerability of the iVS-1 Probiotic study product. This will be measured by the assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs), and AE withdrawals reported over the study product/placebo use period. This is monitored over the 6-week product/placebo use period.	6 weeks
Anxiety	The goal is to evaluate the impact of the iVS-1 Probiotic study product on anxiety. This will be measured by the change in the Generalized Anxiety Disorder-7 (GAD-7) score between the placebo and study product group. Baseline period will be compared as well.	6-weeks
Sleep Disturbances	The goal is to evaluate the impact of the iVS-1 Probiotic study product on sleep disturbance. This will be measured by the change in the Insomnia Severity Index (ISI) score between the placebo and study product group. Baseline period will be compared as well.	6 weeks
Sleep Quality	The goal is to evaluate the impact of the iVS-1 Probiotic study product on sleep quality. This will be measured by the change in average sleep quality score between the placebo and study product group, as assessed by a daily 10-point Visual Analogue Scale (VAS). Baseline period will be compared as well.	6 weeks
Daytime Alertness	The goal is to evaluate the impact of the iVS-1 Probiotic study product on daytime alertness. This will be measured by the change in average restedness score between the placebo and study product group, as assessed by a daily 10-point VAS scale. Baseline period will be compared as well.	6 weeks
Stress	The goal is to evaluate the impact of the iVS-1 Probiotic study product on stress. This will be measured by the change in average stress score between the study product and placebo group, as assessed by a daily 10-point VAS scale. Baseline period will be compared as well.	6 Week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on gut microbiota	To evaluate the impact of iVS-1 Probiotic study product on gut microbiota composition and function by looking at the change from baseline in gut microbiome, specifically in probiotic species of Bifidobacteria and quantity of B. adolescentis, between placebo and study product group at Week 6 as measured and analyzed from stool specimens.	6 weeks

Collaborators and Investigators

• Sponsor: Synbiotic Health
• Collaborators: People Science, Inc.
• Investigators: Principal Investigator: Noah Craft, MD, People Science, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): July 27, 2026
• Study Completion (Estimated): September 23, 2026

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Abdominal Pain; Diarrhea; Constipation; Bloating; Flatulence; Gas; Digestive Symptoms
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Signs and Symptoms, Digestive; Connective Tissue Diseases; Carbohydrate Metabolism, Inborn Errors; Lysosomal Storage Diseases; Mucinoses; Mucopolysaccharidoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Digestive System Diseases; Abdominal Pain; Constipation; Diarrhea; Mucopolysaccharidosis IV; Flatulence; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: PS17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is no plan currently to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No