Safety and Tolerance of a Novel Three-Strain Probiotic in Healthy Adults (NCT07566884) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Tolerance of a Novel Three-Strain Probiotic in Healthy Adults
Ireland30 participantsStarted 2024-09-23
Plain-language summary
This Phase I \& II study evaluates the safety and tolerability of 8 weeks of daily supplementation with high-dose versus standard-dose of a novel three-strain probiotic. Safety and tolerability will be assessed by adverse events, safety blood profile, and vital signs. Secondary assessments include food cravings, gastrointestinal outcomes, sleep, quality of life, subjective ratings of hunger and satiety and associated hormone responses including plasma GLP-1, glucose, and insulin.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be able to give written informed consent.
✓. Be between 18 and 65 years, inclusive.
✓. Has a BMI: Phase I ≤29.9kg/m2. Phase II ≤34.9kg/m2.
✓. Mean total food craving score (FCI-UK) of ≥2.5 at screening visit. (Phase I only) 5. Stable weight for the past 30 days (defined as ± 2.3kg).
Exclusion criteria
✕. 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.
What they're measuring
1
Phase 1 - Safety and Tolerability - As assessed by Occurrence of Adverse of Events
Timeframe: 8 weeks
2
Phase 2 - Safety and Tolerability - As assessed by Occurrence of Adverse of Events
✕. 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 food allergies or other issues with foods that would preclude intake of the Study Products.