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| Name | Class |
|---|---|
| Global Institute of Probiotics | OTHER |
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This investigation will evaluate the effect of Digesta-Lac in adults with occasional constipation in a single-center, randomized, double-blind, placebo-controlled, parallel group 2-arm study for 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Population with Digesta Lac | Active Comparator | Digesta Lac is Lactobacillus bulgaricus LB-51 at 2.0 billion cfu with non-medicinal ingredients: cellulose, potato powder, chick pea extract, vitamin c, L-leucine, vegetable capsule (hypromellose) |
|
| Healthy Population with Placebo | Placebo Comparator | Placebo contains: cellulose, Organic Whole Grain Brown Rice Milk Concentrate, L-Leucine, potato powder, vegetable capsule (hypromellose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digesta Lac | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements | Baseline to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| The between group difference in the average number of weekly complete spontaneous bowel movements | Baseline to Day 21 | |
| The percentage of responders vs. non- responders for the average number of weekly complete spontaneous bowel movements | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory parameters of safety - CBC | Screening to Day 21 | |
| Laboratory parameters of safety - Electrolytes | Screening to Day 21 | |
| Laboratory parameters of safety - Kidney function markers |
Inclusion Criteria:
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: Double barrier method, 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)), Intrauterine devices, Vasectomy of partner, Non-heterosexual lifestyle
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Other |
|
| The mean difference (probiotic - placebo) in the number of weekly spontaneous bowel movements | Baseline to Day 21 |
| The between group difference in the average number of weekly spontaneous bowel movements | Baseline to Day 21 |
| The percentage of responders vs. non- responders for the average number of weekly spontaneous bowel movements | Day 21 |
| The mean difference (probiotic - placebo) in the number of weekly bowel movements | Baseline to Day 21 |
| The between group difference in the average number of weekly bowel movements | Baseline to Day 21 |
| The percentage of responders vs. non- responders for the average number of weekly bowel movements | Day 21 |
| Changes in bowel habits (straining, feeling of complete evacuation) as assessed by the daily bowel habits diary | Baseline to Day 21 |
| Change in Bristol Stool Score | Baseline to Day 21 |
| Change in symptoms related to constipation determined by the Gastrointestinal Symptom Rating Scale | Baseline to Day 21 |
| Mean score of the Product Perception Questionnaire | Day 21 |
| The between group difference in the percentage of subjects that used a laxative | Baseline to Day 21 |
| The between group difference in the total number of days per subject that a laxative | Baseline to Day 21 |
| Screening to Day 21 |
| Laboratory parameters of safety - Liver function markers | Screening to Day 21 |
| Anthropometric measures - Weight | Screening to Day 21 |
| Anthropometric measures - BMI | Screening to Day 21 |
| Anthropometric measures - Blood Pressure | Screening to Day 21 |
| Anthropometric measures - Heart Rate | Screening to Day 21 |
| Incidence of Adverse Events | Baseline to Day 21 |