- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418507
An Evaluation of the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation
December 12, 2017 updated by: KGK Science Inc.
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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London, Ontario, Canada, N6A 5R8
- KGK Synergize Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations
- 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:
- 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.
- Subjects with an active eating disorder
- Subjects who have used an over-the-counter or prescription laxative medication within 2 weeks prior to screening.
- Subjects who have used probiotic or fiber supplements (or probiotic/fiber enriched foods) within 4 weeks prior to screening
- Subjects who have used an antibiotic within 4 weeks prior to screening
- Subjects who have used medications in the investigators opinion known to cause constipation (i.e. opiates) within 4 weeks of screening
- Subjects using Medicinal Marijuana
- Subjects who use illicit drugs or have a history of alcohol or drug abuse within the past 6 months
- Subjects who currently consume greater than 2 standard alcoholic drinks per day.
- Subjects who have participated in a clinical research trial within 30 days prior to randomization.
- Subjects with an allergy or sensitivity to the investigational product ingredient
- Subjects who are cognitively impaired and/or who are unable to give informed consent
- Subjects who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the Principle Investigator, may adversely affect the subjects' ability to complete the study or its measures or which may pose significant risk to the subject.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Proprietary Probiotic Blend
A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg
|
A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg
|
PLACEBO_COMPARATOR: Placebo
The placebo is administered to randomized healthy participants
|
The placebo is administered to randomized healthy participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in the symptoms of constipation as measured by the PAC SYM questionnaire
Time Frame: Baseline to Day 29
|
Baseline to Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in stool consistency as measured by the Bristol Stool Scale
Time Frame: Baseline to Day 29
|
Baseline to Day 29
|
|
Changes in stool frequency
Time Frame: Baseline to Day 29
|
Weekly mean Complete Spontaneous Bowel Movements
|
Baseline to Day 29
|
Changes in quality of life questionnaire score
Time Frame: Baseline to Day 29
|
Baseline to Day 29
|
|
Changes in microbial composition of feces
Time Frame: Baseline to Day 29
|
Baseline to Day 29
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in blood safety parameters
Time Frame: Baseline to Day 29
|
CBC, electrolytes, creatinine, AST, ALT, GGT and bilirubin
|
Baseline to Day 29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tetyana Pelipyagina, MD, tetyana@kgksynergize.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 29, 2015
Primary Completion (ACTUAL)
April 1, 2016
Study Completion (ACTUAL)
May 1, 2016
Study Registration Dates
First Submitted
March 6, 2015
First Submitted That Met QC Criteria
April 13, 2015
First Posted (ESTIMATE)
April 16, 2015
Study Record Updates
Last Update Posted (ACTUAL)
December 13, 2017
Last Update Submitted That Met QC Criteria
December 12, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14PPHU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Functional Constipation
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Institute of Medical Sciences and SUM HospitalNot yet recruitingFunctional Constipation | Constipation - Functional | Constipation Chronic Idiopathic | Fecal Impaction | Pediatric Functional ConstipationIndia
-
Huazhong University of Science and TechnologyWuhan Union Hospital, China; Guangzhou University of Traditional Chinese Medicine and other collaboratorsUnknownFunctional Constipation | Functional DiarrheaChina
-
usMIMA S.L.University of York; County Durham and Darlington NHS Foundation TrustNot yet recruitingConstipation | Constipation-predominant Irritable Bowel Syndrome | Constipation - Functional | Constipation Chronic Idiopathic | Constipation; Neurogenic
-
Chulalongkorn UniversityNot yet recruitingFunctional ConstipationThailand
-
Min-Tze LIONGDeyang People's HospitalRecruiting
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-
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-
Gelesis, Inc.Not yet recruitingConstipation - Functional
-
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Société des Produits Nestlé (SPN)CompletedConstipation - FunctionalIreland
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