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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Ontario
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

    1. Straining during at least 25% of defecations
    2. Lumpy or hard stools in at least 25% of defecations
    3. Sensation of incomplete evacuation for at least 25% of defecations
    4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Proprietary Probiotic Blend
A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg
Dietary supplement: Proprietary Probiotic Blend
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
Other: Placebo
The placebo is administered to randomized healthy participants

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KGK Science Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UAS Labs LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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