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An Evaluation of the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02418507
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
UAS Labs LLC
Information provided by (Responsible Party):
KGK Science Inc.

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.

Condition or disease Intervention/treatment Phase
Functional Constipation Dietary Supplement: Proprietary Probiotic Blend Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation
Actual Study Start Date : May 29, 2015
Actual Primary Completion Date : April 1, 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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
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




Primary Outcome Measures :
  1. Changes in the symptoms of constipation as measured by the PAC SYM questionnaire [ Time Frame: Baseline to Day 29 ]

Secondary Outcome Measures :
  1. Changes in stool consistency as measured by the Bristol Stool Scale [ Time Frame: Baseline to Day 29 ]
  2. Changes in stool frequency [ Time Frame: Baseline to Day 29 ]
    Weekly mean Complete Spontaneous Bowel Movements

  3. Changes in quality of life questionnaire score [ Time Frame: Baseline to Day 29 ]
  4. Changes in microbial composition of feces [ Time Frame: Baseline to Day 29 ]

Other Outcome Measures:
  1. Changes in blood safety parameters [ Time Frame: Baseline to Day 29 ]
    CBC, electrolytes, creatinine, AST, ALT, GGT and bilirubin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418507


Locations
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Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Science Inc.
UAS Labs LLC
Investigators
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Principal Investigator: Tetyana Pelipyagina, MD tetyana@kgksynergize.com
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Responsible Party: KGK Science Inc.
ClinicalTrials.gov Identifier: NCT02418507    
Other Study ID Numbers: 14PPHU
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive