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

Occasional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423564
• Other study ID #: 14PCHN
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2015
• Last updated: April 10, 2018
• Start date: June 12, 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2018
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2016
• Est. primary completion date: April 12, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Occasional Constipation

Intervention

Dietary Supplement:
• Digesta Lac

Other:
• Placebo

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	Global Institute of Probiotics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Laboratory parameters of safety - CBC		Screening to Day 21
Other	Laboratory parameters of safety - Electrolytes		Screening to Day 21
Other	Laboratory parameters of safety - Kidney function markers		Screening to Day 21
Other	Laboratory parameters of safety - Liver function markers		Screening to Day 21
Other	Anthropometric measures - Weight		Screening to Day 21
Other	Anthropometric measures - BMI		Screening to Day 21
Other	Anthropometric measures - Blood Pressure		Screening to Day 21
Other	Anthropometric measures - Heart Rate		Screening to Day 21
Other	Incidence of Adverse Events		Baseline to Day 21
Primary	Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements		Baseline to Day 21
Secondary	The between group difference in the average number of weekly complete spontaneous bowel movements		Baseline to Day 21
Secondary	The percentage of responders vs. non- responders for the average number of weekly complete spontaneous bowel movements		Day 21
Secondary	The mean difference (probiotic - placebo) in the number of weekly spontaneous bowel movements		Baseline to Day 21
Secondary	The between group difference in the average number of weekly spontaneous bowel movements		Baseline to Day 21
Secondary	The percentage of responders vs. non- responders for the average number of weekly spontaneous bowel movements		Day 21
Secondary	The mean difference (probiotic - placebo) in the number of weekly bowel movements		Baseline to Day 21
Secondary	The between group difference in the average number of weekly bowel movements		Baseline to Day 21
Secondary	The percentage of responders vs. non- responders for the average number of weekly bowel movements		Day 21
Secondary	Changes in bowel habits (straining, feeling of complete evacuation) as assessed by the daily bowel habits diary		Baseline to Day 21
Secondary	Change in Bristol Stool Score		Baseline to Day 21
Secondary	Change in symptoms related to constipation determined by the Gastrointestinal Symptom Rating Scale		Baseline to Day 21
Secondary	Mean score of the Product Perception Questionnaire		Day 21
Secondary	The between group difference in the percentage of subjects that used a laxative		Baseline to Day 21
Secondary	The between group difference in the total number of days per subject that a laxative		Baseline to Day 21