Safety and Tolerability in Healthy VolunteersNCT07824011
Safety and Tolerability Evaluation of IgG Binding Protein LT
A study testing IgG Binding Protein LT in people with Safety and Tolerability in Healthy Volunteers, run by Bactolife A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Volunteers
- What is being tested?
- IgG Binding Protein LT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- 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.
- Self reports more than 3 bowel movements in the Chloe App in a 7 day period before or during screening.
- 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.
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- 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 11 weeks.
Who cannot join
- Any potential participants who:
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Concomitant Therapies:
- Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
- 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
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- 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.
- 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.
- Known hypersensitivity or previous allergic reaction to the study product ingredients:
- IgG Binding Protein LT (BP-LT)
- Microcrystalline cellulose
- Magnesium stearate
- 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).
- 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.
- 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.
- 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
- Planning to make significant dietary or lifestyle changes during the study period (e.g., travel, new diet).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
People Science In.c.
Los Angeles, California, 90045
Jane Kohan, 213-342-5681, jkohan@peoplescience.health
Ashley Mateus, Ph.D, 213-342-5681, ashley@peoplescience.health
About this study
Official title: A Placebo-controlled, Double-blind, Safety and Experience Evaluation of IgG Binding Protein LT (BP-LT).
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.
Read the 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.
- Being tested
- IgG Binding Protein LT, Placebo
- Keywords
- IgG Binding Protein LT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG Binding Protein LTDietary supplement
Dietary supplement containing IgG Binding Protein LT
PlaceboDietary supplement
Dietary supplement without IgG Binding Protein LT
| Study group | Role | What they receive |
|---|---|---|
| IgG Binding Protein LT | Experimental | Received oral capsules twice daily containing IgG Binding Protein LT Receives: Dietary Supplement: IgG Binding Protein LT |
| Placebo | Placebo comparator | Received oral Placebo capsules twice daily without IgG Binding Protein LT Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of a 3-week, twice-daily intake of IgG Binding Protein LT (BP-LT) in healthy adults.
The incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) per product causality.
Measured: From Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start12 Oct 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bactolife A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Ashley Mateus, Ph.D, Principal investigator, People Science, In.c.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824011
- Sponsor's protocol ID
- PS47
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind, Safety and Experience Evaluation of IgG Binding Protein LT (BP-LT).
- ClinicalTrials.gov ID
- NCT07824011
- Acronym / sponsor ID
- PS47
- Keywords
- IgG Binding Protein LT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bactolife A/SIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Sep 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IgG Binding Protein LT | Experimental | Dietary Supplement: IgG Binding Protein LTReceived oral capsules twice daily containing IgG Binding Protein LT |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboReceived oral Placebo capsules twice daily without IgG Binding Protein LT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
- 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.
- Self reports more than 3 bowel movements in the Chloe App in a 7 day period before or during screening.
Key exclusion criteria (35 listed)
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Concomitant Therapies:
- Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- Known hypersensitivity or previous allergic reaction to the study product ingredients:
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 |
|---|---|---|
| IgG Binding Protein LTDietary supplement containing IgG Binding Protein LT | Dietary supplement | IgG Binding Protein LT |
| PlaceboDietary supplement without IgG Binding Protein LT | Dietary supplement | Placebo |
Primary outcome
To evaluate the safety and tolerability of a 3-week, twice-daily intake of IgG Binding Protein LT (BP-LT) in healthy adults.
Time frame: From Baseline to Week 4
The incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) per product causality.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Ashley Mateus, Ph.D principal investigator
People Science, In.c.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IgG Binding Protein LT in people with Safety and Tolerability in Healthy Volunteers, run by Bactolife A/S 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 9 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 16 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Kohan (213-342-5681, jkohan@peoplescience.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of a 3-week, twice-daily intake of IgG Binding Protein LT (BP-LT) in healthy adults. (time frame: From Baseline to Week 4). 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 16 Oct 2026.