Clinical trial NCT02423564: A Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation
Official title: A Double-blind, Placebo-controlled, Parallel Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Occasional Constipation
Keywords: Probiotic
Digesta-Lac
Occasional Constipation
Constipation
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Global Institute of Probiotics
First posted: 2015-04-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements
timeFrame: Baseline to Day 21
Secondary outcomes:
measure: The between group difference in the average number of weekly complete spontaneous bowel movements
timeFrame: Baseline to Day 21
measure: The percentage of responders vs. non- responders for the average number of weekly complete spontaneous bowel movements
timeFrame: Day 21
measure: The mean difference (probiotic - placebo) in the number of weekly spontaneous bowel movements
timeFrame: Baseline to Day 21
measure: The between group difference in the average number of weekly spontaneous bowel movements
timeFrame: Baseline to Day 21
measure: The percentage of responders vs. non- responders for the average number of weekly spontaneous bowel movements
timeFrame: Day 21
measure: The mean difference (probiotic - placebo) in the number of weekly bowel movements
timeFrame: Baseline to Day 21
measure: The between group difference in the average number of weekly bowel movements
timeFrame: Baseline to Day 21
measure: The percentage of responders vs. non- responders for the average number of weekly bowel movements
timeFrame: Day 21
measure: Changes in bowel habits (straining, feeling of complete evacuation) as assessed by the daily bowel habits diary
timeFrame: Baseline to Day 21
measure: Change in Bristol Stool Score
timeFrame: Baseline to Day 21
measure: Change in symptoms related to constipation determined by the Gastrointestinal Symptom Rating Scale
timeFrame: Baseline to Day 21
measure: Mean score of the Product Perception Questionnaire
timeFrame: Day 21
measure: The between group difference in the percentage of subjects that used a laxative
timeFrame: Baseline to Day 21
measure: The between group difference in the total number of days per subject that a laxative
timeFrame: Baseline to Day 21
Other outcomes:
measure: Laboratory parameters of safety - CBC
timeFrame: Screening to Day 21
measure: Laboratory parameters of safety - Electrolytes
timeFrame: Screening to Day 21
measure: Laboratory parameters of safety - Kidney function markers
timeFrame: Screening to Day 21
measure: Laboratory parameters of safety - Liver function markers
timeFrame: Screening to Day 21
measure: Anthropometric measures - Weight
timeFrame: Screening to Day 21
measure: Anthropometric measures - BMI
timeFrame: Screening to Day 21
measure: Anthropometric measures - Blood Pressure
timeFrame: Screening to Day 21
measure: Anthropometric measures - Heart Rate
timeFrame: Screening to Day 21
measure: Incidence of Adverse Events
timeFrame: Baseline to Day 21
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References: