A Double-blind, Placebo-controlled, Parallel Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation

KGK Science Inc.1 site in 1 country54 target enrollmentJune 12, 2015

ConditionsOccasional Constipation

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Occasional Constipation
Sponsor: KGK Science Inc.
Enrollment: 54
Locations: 1
Primary Endpoint: Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 12, 2015

End Date

May 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

KGK Science Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female between 18-65 years of age (inclusive)
•If female, 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: 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
•BMI 18.5-35.0kg/m2
•Subjects must have \< 3 bowel movements per week for at least 2 weeks (but for not more than 12 weeks in the past 6 months) prior to randomization (confirmed at screening and baseline) and the presence of at least one other bowel symptom of constipation in at least 25% of defecations; Hard stools. or complete lack of loose or watery stools, straining during defecation, feelings of incomplete evacuation, abdominal discomfort, bloating/distension
•Healthy as determined by laboratory results, medical history and physical exam
•Subjects must agree not to use any other products or therapies (i.e. enemas) to treat their constipation during the run-in to the study (7 days prior to baseline) or during the course of the study except as a rescue medication.
•Agrees not to change current dietary habits (with the exception of avoiding pro- and prebiotics), smoking habits and activity/training levels one week prior to randomization and during the course of the study
•Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria

•Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
•Subjects currently under a doctor's care and treatment for constipation
•Subjects that have a history of chronic constipation(defined as \<3 bowel movements per week for more than 3 months) due to any underlying cause (IBS, functional constipation \[chronic constipation\], IBD, ulcer, etc.) based on self-report, physical examination, or documented medical history
•Subjects who have severe abdominal pain as the predominant constipation symptom as determined by the Principal Investigator.
•Subjects who have a history of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis, gastric retention or obstruction, bowel resection, rectocele, colostomy, IBS, Crohn's disease, episiotomy or hemorrhoids.
•Subjects with a history of spinal injuries and/or surgeries which could result in an atonic colon or saddle anesthesia (i.e. spinal fusion in the lumbar spine)
•Subjects who have been hospitalized within the past 3 months
•Subjects with known renal or hepatic insufficiency
•Subjects with gastrointestinal bleeding or acute infection
•Subjects who use prescription medication to treat constipation

Outcomes

Primary Outcomes

Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements

Time Frame: Baseline to Day 21

Secondary Outcomes

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)
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)