NCT07566884进行中（未招募）不适用
A Two-Phase Study on the Safety and Tolerance of a Novel Probiotic in Healthy Adults: Open-Label and Double-Blind, Placebo-Controlled Study
Pendulum Therapeutics1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月23日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
A Two-Phase Study safety and tolerance study:
Phase I: Open-Label Study Phase II: Randomised Double-Blind, Placebo-Controlled Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible for inclusion, the Participant must fulfill all the following criteria:
- •Be able to give written informed consent.
- •Be between 18 and 65 years, inclusive.
- •Has a BMI: Phase I ≤29.9kg/m
- •Phase II ≤34.9kg/m
- •Mean total food craving score (FCI-UK) of ≥2.5 at screening visit. (Phase I only)
- •Stable weight for the past 30 days (defined as ± 2.3kg).
- •6. Willing to consume the Study Product daily for the duration of the study.
排除标准
- •Participants will be excluded from the study if they meet any of the following 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.
- •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.
- •Known hypersensitivity to any component of the probiotic used in the study (Clostridium butyricum WB-STR-0006, Akkermansia muciniphila WB-STR-0001, Bifidobacterium infantis, chicory inulin, microcrystalline cellulose, l-leucine, hypromellose (vegetarian capsule), silica)
- •Known hypersensitivity or allergy to any component of the meal product used in the meal challenge (allergens: milk and soy)
- •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: a. Gastrointestinal condition (including GI bleeding in the past 3 months) b. Major gastrointestinal surgery or explorations (cholecystectomy and appendectomy are allowed) c. Cancer (in the past 1 year) d. Active autoimmune condition e. Cardiovascular disease (in the past 3 months)
- •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: a. Oral antibiotics or Antifungals (in the past 1 month) b. Medications impacting gut motility (in the 2 weeks prior to baseline) c. GLP-1 receptor agonists (in the past 6 months) d. Sulfonylureas (in the past 6 months) e. Proton Pump Inhibitors (in the past 1 month) f. Laxatives (in the past 1 month)
- •6. Current or recent (in the past 1 month) use of prohibited nutritional or non-nutritional supplements, including:
- •Probiotics/Prebiotics
- •Fibre supplements
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- •8. Participants may not be receiving treatment involving experimental drugs/supplements. If the Participant has been in a recent experimental study, these must have been completed not less than 90 days for drugs and 30 days for supplements prior to this study.
- •9. Current participation or planned participation in a weight loss program during the study period
- •Known hypersensitivity to >4 first-line antimicrobial therapies against Akkermansia muciniphila: Penicillin, Piperacillin, Amoxicillin, Ampicillin, Tetracycline
- •Known hypersensitivity to >4 first-line antimicrobial therapies against Clostridium butyricum: Penicillin, Piperacillin, Amoxicillin, Ampicillin, Tetracycline, Vancomycin, Cefoxitin
- •Known hypersensitivity to >4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin
研究组 & 干预措施
Phase 1 - Standard Dose
Active Comparator
1 capsule
干预措施: Three-Strain Probiotic (Dietary Supplement)
Phase 1 - High Dose
Active Comparator
2 capsules
干预措施: Three-Strain Probiotic (Dietary Supplement)
Phase 2 - Active
Active Comparator
Dose selected from Phase 1
干预措施: Three-Strain Probiotic (Dietary Supplement)
Phase 2 - Placebo
Placebo Comparator
干预措施: Phase 2 - Placebo (Dietary Supplement)
研究者
研究点 (1)
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