The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers

Официальное название

The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers: a Double-blind, Randomized Placebo-controlled Study

Обзор

The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post LB (170 mg) on bowel movements in healthy adult volunteers compared to Placebo adjusted on baseline. The main question\[s\] it aims to answer \[is/are\]: Does Humiome ® Post LB improve bowel movements with self-reported GI issues? Participants will be provided Humiome ® Post LB (170 mg) for 8 weeks and asked to complete a study diary, questionnaires, and stool samples.

Вмешательства

• Пищевая добавка Humiome ® Post LB
  Participants will be instructed to take one capsule with a glass of water after the first meal of the day.
• Другое Placebo
  Participants will be instructed to take one capsule with a glass of water after the first meal of the day.

Первичные конечные точки

• To evaluate the effect of Humiome ® Post LB (170 mg) supplementation on bowel movements in healthy adult volunteers compared to Placebo [Срок оценки: Day 0 to 56]

Вторичные конечные точки (12)

• The difference in frequency of bowel movements between Humiome® Post LB and Placebo [Срок оценки: Day 0 to 28]
• The difference in frequency of bowel movements after Humiome® Post LB and Placebo compared to baseline. [Срок оценки: Day 0 to 28]
• The difference in frequency of bowel movements after Humiome® Post LB and Placebo compared to baseline. [Срок оценки: Day 0 to 56]
• The difference between Humiome® Post LB and Placebo in stool consistency. [Срок оценки: Day 0 to 28]
• The difference between Humiome® Post LB and Placebo in stool consistency. [Срок оценки: Day 0 to 56]
• The difference between Humiome® Post LB and Placebo in quality of life [Срок оценки: Day 0 to 28]
• The difference between Humiome® Post LB and Placebo in quality of life [Срок оценки: Day 0 to 56]
• The difference after Humiome® Post LB and Placebo compared to baseline in stool consistency [Срок оценки: Day 0 to 28]
• The difference after Humiome® Post LB and Placebo compared to baseline in stool consistency [Срок оценки: Day 0 to 56]
• The difference after Humiome® Post LB and Placebo compared to baseline in quality of life [Срок оценки: Day 0 to 28]
• The difference after Humiome® Post LB and Placebo compared to baseline in quality of life [Срок оценки: Day 0 to 56]
• The difference between Humiome® Post LB and Placebo in fecal microbial composition [Срок оценки: Day 0 to 56]

Критерии участия

Критерии включения

• Be able to give written informed consent.
• Self-reported gastrointestinal issues defined as 10-20 bowel movements per week and a score of 5-6 for ≥20% of stools based on the BSS in the 2 weeks prior to baseline, as assessed by the Qualified Investigator (QI).
• Self-reported GI issues such as bloating, mild cramping, and urgency, as assessed by the QI.
• Be between 18 and 75 years of age, inclusive.
• Have a BMI of between 18.5 - 29.9 kg/m2, inclusive.
• Self-reported stable body weight (<5% change) over the past 3 months.
• Be in general good health, as determined by the QI.
• Willing to avoid consuming prebiotic, probiotic, postbiotics, fiber-rich and dietary supplements, anti-diarrheal and anti-constipation medication until the end of the study (see Section 5.6).
• Willing to maintain current dietary habits and lifestyle, including level of physical activity, allowed medication/supplements habits for the duration of the study.
• Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,

Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Abstinence and agrees to use contraception if planning on becoming sexually active during the study

Критерии исключения

• Failure to meet any one of the inclusion criteria.
• Females who are pregnant, lactating or wish to become pregnant during the study.
• Are lactose intolerant or have any other hypersensitivity/allergy to any of the components of the test product.
• Meeting Irritable Bowel Syndrome (IBS) diagnostic criteria as defined by Rome IV criteria, i.e. having recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:

• Related to defecation.
• Associated with a change in frequency of stool.
• Associated with a change in form (appearance) of stool. Criteria need to be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
• Have suffered from diarrhea (defined as ≥3 bowel movements per day and 6-7 on BSS) at any time two weeks prior to run-in, as assessed by the QI.
• Experience alarm features such as weight loss, rectal bleeding, or recent change in bowel habit (<3 months), as assessed by the QI.
• Have taken antibiotics within the previous 2 months prior to the run-in period as assessed by QI (see Section 5.6.1).
• Unstable hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg). Treatment on a stable dose of medication for at least 3 months will be considered by the QI.
• Known history of or ongoing HIV, hepatitis or clinically important, as judged by the QI, endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary conditions.
• Current or history of any significant diseases of the gastrointestinal tract (including but not limited to Crohn's disease, ulcerative colitis, celiacs disease, colectomy), as assessed by the QI.
• Have planned a major surgery during the study period as assessed by the QI.
• Have a history of drug and/or alcohol abuse in the past 12 months at the time of enrolment.
• Alcohol intake average of >2 standard drinks per day as assessed by the QI
• Have made any major dietary changes in the past 3 months prior to run-in period.
• Currently consuming a vegetarian or vegan diet.
• Are planning a holiday over the study period that would alter dietary patterns as assessed by the QI.
• Have planned major changes in lifestyle (i.e. diet, weight loss program, exercise level, travelling) during the duration of the study.
• Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period.
• Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to abstain for the duration of the study period.
• Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant.
• Participation in other clinical research studies 30 days prior to the run-in period, as assessed by the QI.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• KGK Science Inc. — London

Идентификаторы

NCT: NCT06937814 · 2024-10-24-POSTL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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