A Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation

A Double-blind, Placebo-controlled, Parallel Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation

This investigation will evaluate the effect of Digesta-Lac in adults with occasional constipation in a single-center, randomized, double-blind, placebo-controlled, parallel group 2-arm study for 3 weeks.

Study Overview

• Status: Completed
• Conditions: Occasional Constipation
• Intervention / Treatment: Other: Placebo; Dietary supplement: Digesta Lac

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female between 18-65 years of age (inclusive)
• If female, 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: Double barrier method, 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)), Intrauterine devices, Vasectomy of partner, Non-heterosexual lifestyle

• BMI 18.5-35.0kg/m2
• Subjects must have < 3 bowel movements per week for at least 2 weeks (but for not more than 12 weeks in the past 6 months) prior to randomization (confirmed at screening and baseline) and the presence of at least one other bowel symptom of constipation in at least 25% of defecations; Hard stools. or complete lack of loose or watery stools, straining during defecation, feelings of incomplete evacuation, abdominal discomfort, bloating/distension
• Healthy as determined by laboratory results, medical history and physical exam
• Subjects must agree not to use any other products or therapies (i.e. enemas) to treat their constipation during the run-in to the study (7 days prior to baseline) or during the course of the study except as a rescue medication.
• Agrees not to change current dietary habits (with the exception of avoiding pro- and prebiotics), smoking habits and activity/training levels one week prior to randomization and during the course of the study
• Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• Subjects currently under a doctor's care and treatment for constipation
• Subjects that have a history of chronic constipation(defined as <3 bowel movements per week for more than 3 months) due to any underlying cause (IBS, functional constipation [chronic constipation], IBD, ulcer, etc.) based on self-report, physical examination, or documented medical history
• Subjects who have severe abdominal pain as the predominant constipation symptom as determined by the Principal Investigator.
• Subjects who have a history of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis, gastric retention or obstruction, bowel resection, rectocele, colostomy, IBS, Crohn's disease, episiotomy or hemorrhoids.
• Subjects with a history of spinal injuries and/or surgeries which could result in an atonic colon or saddle anesthesia (i.e. spinal fusion in the lumbar spine)
• Subjects who have been hospitalized within the past 3 months
• Subjects with known renal or hepatic insufficiency
• Subjects with gastrointestinal bleeding or acute infection
• Subjects who use prescription medication to treat constipation
• Subjects who have previously suffered from slipped discs
• Subjects who plan to use OTC laxatives or stool softeners, or any other products meant to treat constipation other than the study supplements, during the treatment period (use as a rescue medication is permitted) or other therapies such as enemas.
• Subjects currently taking or taken within 28 days of randomization a concomitant medication that causes constipation which in the Principle Investigator's opinion may impact the study results.
• Any non-gastrointestinal disease/complication that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
• Immunodeficiency (i.e. HIV positive, rheumatoid arthritis, history of organ transplant)
• Clinically significant abnormal laboratory results at screening (e.g. AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN; serum creatinine > 1.5 x ULN; hemoglobin < 140 g/L for males and < 123 g/L for females)
• Abdominal or perineal surgery within 6 months of randomization
• Subjects who plan on engaging in anal intercourse during the run-in or treatment periods of the trial. Enemas are not allowed within 7 days of randomization or throughout the trial.
• Participation in a clinical research trial within 30 days prior to randomization or participation in a clinical trial researching a probiotic within 60 days prior to randomization
• Currently taking anti-psychotic medication
• Allergy or sensitivity to study supplement ingredients
• Use of pre- and probiotics within 8 weeks prior to randomization
• Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the past 6 months
• Individuals who are cognitively impaired and/or who are unable to give informed consent.
• Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Population with Digesta Lac; Digesta Lac is Lactobacillus bulgaricus LB-51 at 2.0 billion cfu with non-medicinal ingredients: cellulose, potato powder, chick pea extract, vitamin c, L-leucine, vegetable capsule (hypromellose)	Dietary supplement: Digesta Lac
Placebo Comparator: Healthy Population with Placebo; Placebo contains: cellulose, Organic Whole Grain Brown Rice Milk Concentrate, L-Leucine, potato powder, vegetable capsule (hypromellose)	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements	Baseline to Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
The between group difference in the average number of weekly complete spontaneous bowel movements	Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly complete spontaneous bowel movements	Day 21
The mean difference (probiotic - placebo) in the number of weekly spontaneous bowel movements	Baseline to Day 21
The between group difference in the average number of weekly spontaneous bowel movements	Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly spontaneous bowel movements	Day 21
The mean difference (probiotic - placebo) in the number of weekly bowel movements	Baseline to Day 21
The between group difference in the average number of weekly bowel movements	Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly bowel movements	Day 21
Changes in bowel habits (straining, feeling of complete evacuation) as assessed by the daily bowel habits diary	Baseline to Day 21
Change in Bristol Stool Score	Baseline to Day 21
Change in symptoms related to constipation determined by the Gastrointestinal Symptom Rating Scale	Baseline to Day 21
Mean score of the Product Perception Questionnaire	Day 21
The between group difference in the percentage of subjects that used a laxative	Baseline to Day 21
The between group difference in the total number of days per subject that a laxative	Baseline to Day 21

Other Outcome Measures

Outcome Measure	Time Frame
Laboratory parameters of safety - CBC	Screening to Day 21
Laboratory parameters of safety - Electrolytes	Screening to Day 21
Laboratory parameters of safety - Kidney function markers	Screening to Day 21
Laboratory parameters of safety - Liver function markers	Screening to Day 21
Anthropometric measures - Weight	Screening to Day 21
Anthropometric measures - BMI	Screening to Day 21
Anthropometric measures - Blood Pressure	Screening to Day 21
Anthropometric measures - Heart Rate	Screening to Day 21
Incidence of Adverse Events	Baseline to Day 21

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Global Institute of Probiotics

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2015
• Primary Completion (Actual): April 12, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Constipation; Probiotic; Digesta-Lac; Occasional Constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 14PCHN