Digestive DiseaseNCT07408518
Impact of B. Adolescentis iVS-1 Probiotic on Gastrointestinal Outcomes
A study testing Probiotic in people with Digestive Disease and Gut Health, run by Synbiotic Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Disease, Gut Health
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to 13 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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)
- 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)
- Participants with a known or suspected gastrointestinal infection, such as:
- Clostridium difficile infection
- Helicobacter pylori infection
- Parasitic infections (e.g., Giardia, Cryptosporidium)
- Participants with a history of gastrointestinal surgery, excluding appendectomy and cholecystectomy.
- Participants with a history of gastrointestinal bleeding or perforation.
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
- Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding.
- Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Digestive Disease, Gut Health
- Being tested
- Probiotic, Placebo
- Keywords
- Digestive Symptoms, Bloating, Gas, Abdominal Pain, Flatulence, Constipation, Diarrhea
- Medical subject headings
- Digestive System Diseases, Mucopolysaccharidosis IV, Abdominal Pain, Flatulence, Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
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.
PlaceboOther
An inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 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. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start20 Jan 2026
- Primary completion13 Jul 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synbiotic Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft, MD, Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408518
- Sponsor's protocol ID
- PS17
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no plan currently to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07408518
- Acronym / sponsor ID
- PS17
- Conditions
- Digestive Disease, Gut Health
- Keywords
- Digestive Symptoms, Bloating, Gas, Abdominal Pain, Flatulence, Constipation, Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Synbiotic HealthIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: ProbioticParticipants 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 | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (30 listed)
- 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:
- Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- Known hypersensitivity or previous allergic reaction to Bifidobacterium adolescentis, microcrystalline cellulose, the capsule material (hydroxypropylmethylcellulose), magnesium stearate and silicon dioxide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticParticipants 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 | Active |
| PlaceboAn inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested. | Other | Placebo |
Primary outcome
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.
7 secondary outcomes
Daily Gastrointestinal Symptoms
Time frame: 6-week
Tolerability of Drug
Time frame: 6 weeks
Anxiety
Time frame: 6-weeks
Sleep Disturbances
Time frame: 6 weeks
Sleep Quality
Time frame: 6 weeks
Daytime Alertness
Time frame: 6 weeks
Stress
Time frame: 6 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided. There is no plan currently to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft, MD principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Digestive Disease and Gut Health, run by Synbiotic Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on Gastrointestinal Symptoms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.