Safety and Tolerability in Healthy Volunteers
Conditions
Keywords
IgG Binding Protein LT
Brief summary
This study evaluates the safety and tolerability of the food ingredient IgG Binding Protein LT (BP-LT) when added to a daily diet. BP-LT is a stable protein ingredient being functional in the gastrointestinal tract and without systemic absorption. This registration covers a decentralized, randomized, double-blind, placebo-controlled clinical study evaluating BP-LT in healthy adults.
Detailed description
Design and duration: Approximately 40 healthy adult volunteers (ages 18-70, balanced by sex and age) will be randomized 1:1 to receive either the study product BP-LT or a matching placebo capsule, taken twice daily (morning after breakfast, evening after dinner) for 3 weeks. Participants, investigators, and study staff are all blinded to group assignment. Total individual participation spans up to 11 weeks: a screening period (up to 4 weeks), a randomization/shipping period (up to 2 weeks), a 1-week baseline period, a 3-week product/placebo use period, and a 1-week end-of-study period. The entire study is decentralized, run remotely through People Science's "Chloe" mobile app/platform, which handles recruitment, e-consent, daily/weekly surveys, and scheduling. There is no in-person clinician relationship; participants self-administer the product, self-report outcomes, and perform at-home biospecimen at baseline and end-of-study. Vitals (blood pressure, heart rate, temperature) are self-measured with provided devices. The primary objective is to evaluate the safety and tolerability of a 3-week, twice-daily intake of BP-LT in healthy adults, measured by incidence of adverse events (AEs) and serious adverse events (SAEs) versus placebo.
Interventions
DIETARY_SUPPLEMENTIgG Binding Protein LT
Dietary supplement containing IgG Binding Protein LT
DIETARY_SUPPLEMENTPlacebo
Dietary supplement without IgG Binding Protein LT
Sponsors
Bactolife A/S
People Science, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The Sponsor Bactolife
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18-70 years of age, inclusive, or the legal age of majority in the participant's state of residence (e.g., 19 years for Alabama and Nebraska; 21 years for Mississippi). 2. In good general health at the time of screening (Investigator discretion). 3. Able to read and understand English. 4. Able to read, understand, and provide informed consent. 5. Self reports more than 3 bowel movements in the Chloe App in a 7 day period before or during screening. 6. Able to consume one capsule (allergen and vegan friendly) the Study Product or Placebo twice daily, not on an empty stomach. The first capsule will be consumed in the morning after breakfast and the second in the evening after dinner. 7. Able to use a personal smartphone device and download Chloe by People Science. 8. Able to receive shipment of the product at an address within the United States. 9. Able to complete study assessments over the course of up to 11 weeks.
Exclusion criteria
Any potential participants who: 1. Do not have a personal smartphone, internet access, or unwilling to download Chloe. 2. Concomitant Therapies: • Participants receiving any investigational therapies or treatments within 30 days prior to randomization. 3. Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded: * Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder * Currently pregnant, of childbearing potential, planning to become pregnant during participation in the study, or are lactating/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. 4. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below: * Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where the Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they complete last study activities). * Has a male sexual partner who is surgically sterilized prior to the Screening and is the only male sexual partner for that Participant. * Sexual partner(s) is/are exclusively female. * Use of acceptable methods of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, hysterectomy, oophorectomy, or salpingectomy, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study. * Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the screening, throughout the study, and two weeks following the end of the study. 5. Known hypersensitivity or previous allergic reaction to the study product ingredients: * IgG Binding Protein LT (BP-LT) * Microcrystalline cellulose * Magnesium stearate 6. Has any significant acute or chronic coexisting health conditions that would prevent the Participant from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the Investigator on the basis of medical history. Excluded health conditions include: * Diagnosed gastrointestinal conditions * Immunocompromised health conditions * Answering "Severe Discomfort" or "Very Severe Discomfort" on any question in the Gastrointestinal Symptom Rating Scale (GSRS). 7. Current or recent use of a medication that the Investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include: * Systemic antibiotics -in the past 12 weeks prior to Screening. * Proton pump inhibitors (PPIs) - in the past 4 weeks prior to Screening. * Non-steroidal anti-inflammatory drugs (NSAIDs) - in the past 2 weeks prior to Screening. 8. Current, recent (in the past 4 weeks prior to Screening) or planned use during study participation of prohibited nutritional or non-nutritional supplements that the Investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. 9. Restrictions during study participation: Participants must refrain from initiating or using any of the following prohibited supplements during the study period include: * Probiotics * Prebiotics * Synbiotics * Postbiotics 10. Planning to make significant dietary or lifestyle changes during the study period (e.g., travel, new diet). 11. Are unlikely for any reason to be able to comply with the study or considered unsuited for participation in the study by the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of a 3-week, twice-daily intake of IgG Binding Protein LT (BP-LT) in healthy adults. | From Baseline to Week 4 | The incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) per product causality. |
Countries
United States
Contacts
CONTACTJane Kohan
CONTACTAshley Mateus, Ph.D
PRINCIPAL_INVESTIGATORAshley Mateus, Ph.D
People Science, In.c.
Outcome results
None listed