Los Angeles, CANCT07824011Now EnrollingIRB Ready

Safety and Tolerability in Healthy Volunteers Clinical Trial in Los Angeles, CA

Access cutting-edge safety and tolerability in healthy volunteers treatment through this clinical trial at a research site in Los Angeles. Study-provided care at no cost to qualified participants.

Sponsored by Bactolife A/S

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Expert Care in Los Angeles

Access safety and tolerability in healthy volunteers specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related safety and tolerability in healthy volunteers treatment provided free

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Check if you qualify for this safety and tolerability in healthy volunteers clinical trial in Los Angeles, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Los Angeles

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Los Angeles site if eligible
  4. 4Begin participation

About This Safety and Tolerability in Healthy Volunteers Study in Los Angeles

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.

Sponsor: Bactolife A/S

Who Can Participate

Inclusion Criteria

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.
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.

Exclusion Criteria

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
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:
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT07824011) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Safety and Tolerability in Healthy Volunteers Treatment Options in Los Angeles, CA

If you're searching for safety and tolerability in healthy volunteers treatment options in Los Angeles, CA, this clinical trial (NCT07824011) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this clinical trial. You'll receive care from experienced safety and tolerability in healthy volunteers specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all safety and tolerability in healthy volunteers clinical trials near you to find additional studies recruiting in your area.

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