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

KGK Science

Status and phase

Completed

Phase 2

Conditions

Functional Constipation

Treatments

Other: Placebo

Dietary Supplement: Proprietary Probiotic Blend

Study type

Interventional

Funder types

Industry

Identifiers

NCT02418507

14PPHU

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.