Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 2:48 PM
Study NCT ID:
NCT07408518
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of B. Adolescentis iVS-1 Probiotic on Gastrointestinal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009085', 'term': 'Mucopolysaccharidosis IV'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D005414', 'term': 'Flatulence'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D009083', 'term': 'Mucopolysaccharidoses'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D017520', 'term': 'Mucinoses'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Impact on gut microbiota', 'timeFrame': '6 weeks', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Impact on Gastrointestinal Symptoms', 'timeFrame': '6 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Daily Gastrointestinal Symptoms', 'timeFrame': '6-week', 'description': '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:\n\n1. Scores by individual dimension (diarrhea, indigestion, constipation, abdominal pain and reflux).\n2. Composite scores at Week 2 and Week 4. Baseline period will be compared as well.'}, {'measure': 'Tolerability of Drug', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Anxiety', 'timeFrame': '6-weeks', 'description': '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.'}, {'measure': 'Sleep Disturbances', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Sleep Quality', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Daytime Alertness', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Stress', 'timeFrame': '6 Week', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digestive Symptoms', 'Bloating', 'Gas', 'Abdominal Pain', 'Flatulence', 'Constipation', 'Diarrhea'], 'conditions': ['Digestive Disease', 'Gut Health']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nParticipants, 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18-75 years old, inclusive.\n* Has self-reported moderate to severe gastrointestinal or digestive symptoms, such as abdominal pain, bloating, flatulence, constipation, or diarrhea.\n* 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).\n* Willingness to refrain from taking probiotics or prebiotics during the study period.\n* Interested in understanding more about their gut health and the use probiotic products.\n* 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.\n* 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.\n* 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.\n* In good general health at the time of screening (Investigator discretion).\n* Able to read and understand English.\n* Able to read, understand, and provide informed consent.\n* Able to use a personal smartphone device and download Chloe by People Science.\n* Able to receive shipment of the product at an address within the United States.\n* Able to complete study assessments over the course of up to 17 weeks.\n\nExclusion Criteria:\n\n* Do not have a personal smartphone, internet access, or unwilling to download Chloe.\n* Currently on a carnivore diet, raw food diet, fruitarian, liquid diet (does not include vegans or vegetarians).\n* Concomitant Therapies:\n\n 1. Participants receiving any investigational therapies or treatments within 30 days prior to randomization.\n 2. Participants currently taking or have taken antibiotics, probiotic, or prebiotic supplements within the past 4 weeks prior to randomization.\n 3. Participants using immunosuppressive medications, systemic steroids, antifungals or other medications known to significantly impact gastrointestinal function or microbiota.\n* Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:\n\n 1. Participants with a clinical diagnosis of any gastrointestinal illness, including but not limited to:\n\n * Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)\n * Gastroesophageal reflux disease (GERD)\n * Gastric or duodenal ulcers\n * Celiac disease\n * Diverticular disease\n * Chronic pancreatitis\n * Gastroparesis\n * Severe liver disease (e.g., cirrhosis, hepatitis, NAFLD acceptable)\n * Gallbladder disease (e.g., cholecystitis, cholelithiasis)\n * Gastrointestinal cancer (Colorectal, Intestinal, Stomach, Liver, Gallbladder)\n 2. Participants with a known or suspected gastrointestinal infection, such as:\n\n * Clostridium difficile infection\n * Helicobacter pylori infection\n * Parasitic infections (e.g., Giardia, Cryptosporidium)\n 3. Participants with a history of gastrointestinal surgery, excluding appendectomy and cholecystectomy.\n 4. Participants with a history of gastrointestinal bleeding or perforation.\n 5. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.\n 6. Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding.\n 7. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.\n 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.\n* Known hypersensitivity or previous allergic reaction to Bifidobacterium adolescentis, microcrystalline cellulose, the capsule material (hydroxypropylmethylcellulose), magnesium stearate and silicon dioxide.\n* 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."}, 'identificationModule': {'nctId': 'NCT07408518', 'briefTitle': 'Impact of B. Adolescentis iVS-1 Probiotic on Gastrointestinal Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synbiotic Health'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PS17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': '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.', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'An inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megha Doshi, MD', 'role': 'CONTACT', 'email': 'megha@peoplescience.health', 'phone': '5626736744'}, {'name': 'Jane Kohan', 'role': 'CONTACT', 'email': 'jane@peoplescience.health'}, {'name': 'Noah craft, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Azure Grant, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Crisel Erfe, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'People Science, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Megha M Doshi, MD', 'role': 'CONTACT', 'email': 'megha@peoplescience.health', 'phone': '15626736744'}, {'name': 'Jane Kohan', 'role': 'CONTACT', 'email': 'jane@peoplescience.health'}], 'overallOfficials': [{'name': 'Noah Craft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'People Science, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There is no plan currently to share IPD with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synbiotic Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'People Science, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}