A Phase 2 interventional study of Digesta Lac and Placebo in Occasional Constipation, sponsored by KGK Science Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-11.
Sponsored by KGK Science Inc. · Phase 2, Interventional, and Other
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.
1,041 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 54 is below the median of 78 across 867 interventional studies indexed under Constipation.
Browse Constipation studies →KGK Science Inc. is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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:
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)
Dietary Supplement: Digesta Lac
Placebo contains: cellulose, Organic Whole Grain Brown Rice Milk Concentrate, L-Leucine, potato powder, vegetable capsule (hypromellose)
Other: Placebo
Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements
Time frame: Baseline to Day 21
The between group difference in the average number of weekly complete spontaneous bowel movements
Time frame: Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly complete spontaneous bowel movements
Time frame: Day 21
The mean difference (probiotic - placebo) in the number of weekly spontaneous bowel movements
Time frame: Baseline to Day 21
The between group difference in the average number of weekly spontaneous bowel movements
Time frame: Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly spontaneous bowel movements
Time frame: Day 21
The mean difference (probiotic - placebo) in the number of weekly bowel movements
Time frame: Baseline to Day 21
The between group difference in the average number of weekly bowel movements
Time frame: Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly bowel movements
Time frame: Day 21
Changes in bowel habits (straining, feeling of complete evacuation) as assessed by the daily bowel habits diary
Time frame: Baseline to Day 21
Change in Bristol Stool Score
Time frame: Baseline to Day 21
Change in symptoms related to constipation determined by the Gastrointestinal Symptom Rating Scale
Time frame: Baseline to Day 21
Mean score of the Product Perception Questionnaire
Time frame: Day 21
The between group difference in the percentage of subjects that used a laxative
Time frame: Baseline to Day 21
The between group difference in the total number of days per subject that a laxative
Time frame: Baseline to Day 21
Laboratory parameters of safety - CBC
Time frame: Screening to Day 21
Laboratory parameters of safety - Electrolytes
Time frame: Screening to Day 21
Laboratory parameters of safety - Kidney function markers
Time frame: Screening to Day 21
Laboratory parameters of safety - Liver function markers
Time frame: Screening to Day 21
Anthropometric measures - Weight
Time frame: Screening to Day 21
Anthropometric measures - BMI
Time frame: Screening to Day 21
Anthropometric measures - Blood Pressure
Time frame: Screening to Day 21
Anthropometric measures - Heart Rate
Time frame: Screening to Day 21
Incidence of Adverse Events
Time frame: Baseline to Day 21
Ran from Jun 2015 to primary completion in Apr 2016, 10 months.
Of 36 phase 2 interventional studies under Constipation, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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