An interventional study of IgG Binding Protein LT and Placebo in Safety and Tolerability in Healthy Volunteers, sponsored by Bactolife A/S. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Bactolife A/S · Not applicable, Interventional, and Other
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.
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.
Bactolife A/S is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any potential participants who:
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 , as outlined below:
Known or previous allergic reaction to the study product ingredients:
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:
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:
Restrictions during study participation: Participants must refrain from initiating or using any of the following prohibited supplements during the study period include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Received oral capsules twice daily containing IgG Binding Protein LT
Dietary Supplement: IgG Binding Protein LT
Received oral Placebo capsules twice daily without IgG Binding Protein LT
Dietary Supplement: Placebo
Dietary supplement containing IgG Binding Protein LT
Dietary supplement without IgG Binding Protein LT
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.
Time frame: From Baseline to Week 4
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Sep 2027, 10 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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