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

NCT02423564 | Completed Phase 2

• 1 other identifier: 14PCHN
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Keywords

Probiotic; Digesta-Lac; Occasional Constipation; Constipation

Outcome Measures

Primary Outcomes (1)

• Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements

  Baseline to Day 21

Secondary Outcomes (14)

• 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

Other Outcomes (9)

• 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

Study Arms (2)

Healthy Population with Digesta Lac

ACTIVE COMPARATOR

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

Healthy Population with Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Digesta Lac DIETARY_SUPPLEMENT

Healthy Population with Digesta Lac

Placebo OTHER

Healthy Population with 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:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• KGK Science Inc.: lead
• Global Institute of Probiotics: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  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: April 13, 2015
• First Posted: April 22, 2015
• Study Start: June 12, 2015
• Primary Completion: April 12, 2016
• Study Completion: May 1, 2016
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

CA (1)