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| Name | Class |
|---|---|
| UAS Labs LLC | INDUSTRY |
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The primary objective for this study is to monitor the change in patient assessed symptoms of constipation in subjects taking the proprietary probiotic blend compared to those taking the placebo. The secondary objective for this study is to additionally monitor changes in stool consistency, stool frequency, quality of life and microbial composition of feces from baseline to Day 29, in all subjects. Safety considerations monitored any changes in blood safety parameters as well as incidence of adverse events throughout the entire study for all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proprietary Probiotic Blend | Active Comparator | A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg |
|
| Placebo | Placebo Comparator | The placebo is administered to randomized healthy participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proprietary Probiotic Blend | Dietary Supplement | A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the symptoms of constipation as measured by the PAC SYM questionnaire | Baseline to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in stool consistency as measured by the Bristol Stool Scale | Baseline to Day 29 | |
| Changes in stool frequency | Weekly mean Complete Spontaneous Bowel Movements | Baseline to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood safety parameters | CBC, electrolytes, creatinine, AST, ALT, GGT and bilirubin | Baseline to Day 29 |
Inclusion Criteria:
Healthy male or female adults, aged 18 to 65 years
BMI of 18.5 kg/m2 to 35.0 kg/m2 (inclusive)
Subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. 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 (condoms with spermicide or diaphragm with spermicide)
Non-hormonal intrauterine devices
Vasectomy of partner
Non-heterosexual lifestyle
Subjects must have at least two of the following criteria based on subject self-reporting, for the past 3 months with the symptoms beginning at least 6 months ago:
Two or more criteria must be met by subjects:
Fewer than three defecations per week
Loose stools are rarely present without the use of laxatives
Insufficient criteria for Irritable Bowel Syndrome
Subjects with an average stool type of < 3 on the Bristol Stool Scale as assessed over the two week run-in period (confirmed at baseline review of bowel habits diary).
Subjects who agree to maintain their current level of physical activity throughout the trial period.
Subjects who agree to discontinue the use of probiotic supplements including foods supplemented with probiotics (i.e. yogurts) or fiber supplements including foods labeled as supplemented with fiber
Subjects who agree to discontinue use of over-the-counter laxative medications (other than the rescue medication provided) within 2 weeks of screening and throughout the trial.
Subjects who successfully complete the run-in period by completing at least 80% of Run-In diary entries, 100% of IPAQ questionnaires and provide fecal sample.
Subjects who understand the nature and purpose of the study including the potential risks and side effects
Subjects who are willing to complete all study procedures including study related questionnaires and comply with study requirements
Subjects who have given voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD | tetyana@kgksynergize.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| Placebo | Other | The placebo is administered to randomized healthy participants |
|
| Changes in quality of life questionnaire score | Baseline to Day 29 |
| Changes in microbial composition of feces | Baseline to Day 29 |