Functional ConstipationPhase 2NCT02418507
An Evaluation of the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation
A Phase 2 study testing Proprietary Probiotic Blend in people with Functional Constipation, run by KGK Science Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Proprietary Probiotic Blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2015to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 25Show fewer
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Functional Constipation
- Being tested
- Proprietary Probiotic Blend, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary Probiotic BlendDietary supplement
A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg
PlaceboOther
The placebo is administered to randomized healthy participants
| Study group | Role | What they receive |
|---|---|---|
| Proprietary Probiotic Blend | Active comparator | A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg Receives: Dietary Supplement: Proprietary Probiotic Blend |
| Placebo | Placebo comparator | The placebo is administered to randomized healthy participants Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the symptoms of constipation as measured by the PAC SYM questionnaire
Measured: Baseline to Day 29
Secondary outcomes (4)
Changes in stool consistency as measured by the Bristol Stool Scale
Measured: Baseline to Day 29
Changes in stool frequency
Weekly mean Complete Spontaneous Bowel Movements
Measured: Baseline to Day 29
Changes in quality of life questionnaire score
Measured: Baseline to Day 29
Changes in microbial composition of feces
Measured: Baseline to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study start29 May 2015
- Primary completion1 Apr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UAS Labs LLC
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, tetyana@kgksynergize.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418507
- Sponsor's protocol ID
- 14PPHU
- Status last verified
- Dec 2017
- First submitted
- 6 Mar 2015
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation
- ClinicalTrials.gov ID
- NCT02418507
- Acronym / sponsor ID
- 14PPHU
- Conditions
- Functional Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- UAS Labs LLC
- Study start
- 29 May 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprietary Probiotic Blend | Active comparator | Dietary Supplement: Proprietary Probiotic BlendA proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg |
| Placebo | Placebo comparator | Other: PlaceboThe placebo is administered to randomized healthy participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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)
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprietary Probiotic BlendA proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg | Dietary supplement | Proprietary Probiotic Blend |
| PlaceboThe placebo is administered to randomized healthy participants | Other | Placebo |
Primary outcome
Changes in the symptoms of constipation as measured by the PAC SYM questionnaire
Time frame: Baseline to Day 29
4 secondary outcomes
Changes in stool consistency as measured by the Bristol Stool Scale
Time frame: Baseline to Day 29
Changes in stool frequency
Time frame: Baseline to Day 29
Changes in quality of life questionnaire score
Time frame: Baseline to Day 29
Changes in microbial composition of feces
Time frame: Baseline to Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Related trials for Functional Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation
Functional Constipation
Active, not recruiting
The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
Constipation, Constipation - Functional
Recruiting
Fiber Nutritional Supplement for Management of Constipation During Pregnancy
Functional Constipation (FC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetyana Pelipyagina, MD principal investigator
tetyana@kgksynergize.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proprietary Probiotic Blend in people with Functional Constipation, run by KGK Science Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the symptoms of constipation as measured by the PAC SYM questionnaire (time frame: Baseline to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.