Phase
Condition
Non-ulcer Dyspepsia (Nud)
Treatment
Placebo
Humiome ® Post LB
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be able to give written informed consent.
Self-reported gastrointestinal issues defined as 10-20 bowel movements per week anda score of 5-6 for ≥50% 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 bythe 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 dietarysupplements, anti-diarrheal and anti-constipation medication until the end of thestudy (see Section 5.6).
Willing to maintain current dietary habits and lifestyle, including level ofphysical activity, allowed medication/supplements habits for the duration of thestudy.
Females not of child-bearing potential, defined as those who have undergone asterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tuballigation, complete endometrial ablation) or have been post-menopausal for at least 1year 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 changingto heterosexual partner(s)
Vasectomy of partner at least 6 months prior to screening
Abstinence and agrees to use contraception if planning on becoming sexually activeduring the study
Exclusion
Exclusion Criteria:
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 thecomponents of the test product.
Meeting Irritable Bowel Syndrome (IBS) diagnostic criteria as defined by Rome IVcriteria, i.e. having recurrent abdominal pain on average at least 1 day/week in thelast 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 befulfilled for the last 3 months with symptom onset at least 6 months prior todiagnosis.
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 inbowel habit (<3 months), as assessed by the QI.
Have taken antibiotics within the previous 2 months prior to the run-in period asassessed by QI (see Section 5.6.1).
Unstable hypertension (systolic blood pressure ≥160 mmHg and/or diastolic bloodpressure ≥100 mmHg). Treatment on a stable dose of medication for at least 3 monthswill be considered by the QI.
Known history of or ongoing HIV, hepatitis or clinically important, as judged by theQI, endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardialinfarction, 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 ofenrolment.
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 asassessed by the QI.
Have planned major changes in lifestyle (i.e. diet, weight loss program, exerciselevel, travelling) during the duration of the study.
Regular use of tobacco or nicotine products in the past six months, as assessed bythe QI. Occasional users will be required to washout and abstain for the duration ofthe study period.
Chronic use of cannabinoid products (>2 times/week). Occasional users will berequired to abstain for the duration of the study period.
Any other condition or lifestyle factor, that, in the opinion of the QI, mayadversely affect the participant's ability to complete the study or its measures orpose significant risk to the participant.
Participation in other clinical research studies 30 days prior to the run-in period,as assessed by the QI.
Study Design
Connect with a study center
KGK Science Inc.
London, Ontario
CanadaActive - Recruiting
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