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

NCT ID: NCT02423564

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-12
• Study Completion Date: 2016-05-31

Brief Summary

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.

Conditions

Occasional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Digesta Lac

Intervention Type: DIETARY_SUPPLEMENT

Healthy Population with Placebo

Placebo contains: cellulose, Organic Whole Grain Brown Rice Milk Concentrate, L-Leucine, potato powder, vegetable capsule (hypromellose)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Digesta Lac

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Global Institute of Probiotics

OTHER

Sponsor Role: collaborator

KGK Science Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tetyana Pelipyagina, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Synergize Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

14PCHN

Identifier Type: -

Identifier Source: org_study_id