A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation

KGK Science Inc.1 site in 1 country100 target enrollmentMay 29, 2015

ConditionsFunctional Constipation

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Functional Constipation
Sponsor: KGK Science Inc.
Enrollment: 100
Locations: 1
Primary Endpoint: Changes in the symptoms of constipation as measured by the PAC SYM questionnaire
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 29, 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

•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:

Exclusion Criteria

•Subjects who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
•Subjects with any unstable medical conditions
•Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems
•Subjects with Type I or Type II diabetes
•Subjects with a history of major gastrointestinal complications (i.e. Crohn's disease, ulcer, cancer, ulcerative colitis)
•History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable
•Subjects with neurological disorders or significant psychiatric illnesses (significance determined by the Qualified Investigator)
•Subjects who are immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis)
•Subjects with any medical condition or a history of abdominal surgery that is deemed exclusionary by the Qualified Investigator
•Subjects who have features which may suggest a more serious underlying cause of chronic constipation such as rectal bleeding, anemia, abrupt weight loss ( 5kg or more within the past month prior to randomization), gastrointestinal polyps, first degree family history of colorectal cancer.

Outcomes

Primary Outcomes

Changes in the symptoms of constipation as measured by the PAC SYM questionnaire

Time Frame: Baseline to Day 29

Secondary Outcomes

Changes in stool consistency as measured by the Bristol Stool Scale(Baseline to Day 29)
Changes in quality of life questionnaire score(Baseline to Day 29)
Changes in microbial composition of feces(Baseline to Day 29)
Changes in stool frequency(Baseline to Day 29)