Safety and User Experience of BP-CBB

NCT07628608 | Recruiting

• 1 other identifier: AFCRO-204
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the first-in human study for the food ingredient BP-CBB and aims aims to build on the excellent safety and tolerability observed in the extensive food safety assessment performed for BP-CBB, as well as the consumer experience with using the product, and to set the scene for future human studies documenting the health-benefits of daily supplementation with BP-CBB for diverse populations.

Conditions

Safety and Tolerability in Healthy Volunteers

Keywords

healthy volunteer; first-in-human; binding protein; safety; Tolerability; User experience

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of once daily intake of the novel food ingredient BP-CBB in healthy adults

  Incidence of all AEs per arm by product causality.

  8 weeks

Study Arms (2)

Test arm

EXPERIMENTAL

Receives Test product containing BP-CBB

Dietary Supplement: BP-CBB

Placebo arm

PLACEBO COMPARATOR

Receives Placebo product without BP-CBB

Dietary Supplement: Placebo

Interventions

BP-CBB DIETARY_SUPPLEMENT

Dietary supplement containing BP-CBB

Test arm

Placebo DIETARY_SUPPLEMENT

Receives dietary supplement without BP-CBB

Placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to give written informed consent.
• Be between 18-65 years, both inclusive.
• Record greater than 3 bowel movements recorded during the one-week run-in period.
• In general, in good health, as determined by the investigator.
• Willing to consume the Study Product once daily for the duration of the study.
• Willing to avoid pro, pre post biotics and any new supplements for the duration of the study

You may not qualify if:

• Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
• 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 Participant discontinues the study prematurely. (Participants utilising 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 present to the clinic for the final visit).
• Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
• Sexual partner(s) is/are exclusively female.
• Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, 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 first screening visit, throughout the study, and two weeks following the end of the study.
• Has a history of drug and/or alcohol abuse.
• Has known food allergies, history of Type I (IgE-mediated) food allergies, or hypersensitivity or other issues with foods or ingredients that would preclude intake of the Study Product (i.e. soya).
• Has any significant acute or chronic coexisting health conditions that would prevent them 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 and routine laboratory test results. Excluded health conditions include:
• Diagnosed gastrointestinal conditions
• Previous bariatric surgery
• Immunocompromised health conditions
• 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 4 weeks prior to Visit 1

Sponsors & Collaborators

• Bactolife A/S: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials

Cork, T23 R50R, Ireland

RECRUITING

Study Officials

• Martin Buckley, Professor

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Harrington

CONTACT

+353 (0) 86-218-8787; eharrington@atlantiatrials.com

Emily Goodbody

CONTACT

+353 (0) 86-218-8787; egoodbody@atlantiatrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sponsor Bactolife
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)