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

NCT02418507 | Completed Phase 2

• 1 other identifier: 14PPHU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Day 29

Secondary Outcomes (4)

• Changes in stool consistency as measured by the Bristol Stool Scale

  Baseline to Day 29

• Changes in stool frequency

  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

Other Outcomes (1)

• Changes in blood safety parameters

  Baseline to Day 29

Study Arms (2)

Proprietary Probiotic Blend

ACTIVE COMPARATOR

A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg

Dietary Supplement: Proprietary Probiotic Blend

Placebo

PLACEBO COMPARATOR

The placebo is administered to randomized healthy participants

Other: Placebo

Interventions

Proprietary Probiotic Blend DIETARY_SUPPLEMENT

A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg

Proprietary Probiotic Blend

Placebo OTHER

The placebo is administered to randomized healthy participants

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• KGK Science Inc.: lead
• UAS Labs LLC: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• Tetyana Pelipyagina, MD

  tetyana@kgksynergize.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: April 16, 2015
• Study Start: May 29, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 13, 2017

Record last verified: 2017-12

Locations

CA (1)