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CompletedNCT02423564Updated Apr 11, 2018

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

A Phase 2 interventional study of Digesta Lac and Placebo in Occasional Constipation, sponsored by KGK Science Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-11.

Sponsored by KGK Science Inc. · Phase 2, Interventional, and Other

Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Occasional Constipation

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Keywords

  • Probiotic
  • Digesta-Lac
  • Occasional Constipation
  • Constipation
03

In context

Constipation

1,041 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 54 is below the median of 78 across 867 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

KGK Science Inc. is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementDigesta Lac
  • OtherPlacebo
06

What researchers measure

Primary outcomes

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

    Time frame: Baseline to Day 21

Secondary outcomes

  1. The between group difference in the average number of weekly complete spontaneous bowel movements

    Time frame: Baseline to Day 21

  2. The percentage of responders vs. non- responders for the average number of weekly complete spontaneous bowel movements

    Time frame: Day 21

  3. The mean difference (probiotic - placebo) in the number of weekly spontaneous bowel movements

    Time frame: Baseline to Day 21

  4. The between group difference in the average number of weekly spontaneous bowel movements

    Time frame: Baseline to Day 21

  5. The percentage of responders vs. non- responders for the average number of weekly spontaneous bowel movements

    Time frame: Day 21

  6. The mean difference (probiotic - placebo) in the number of weekly bowel movements

    Time frame: Baseline to Day 21

  7. The between group difference in the average number of weekly bowel movements

    Time frame: Baseline to Day 21

  8. The percentage of responders vs. non- responders for the average number of weekly bowel movements

    Time frame: Day 21

  9. Changes in bowel habits (straining, feeling of complete evacuation) as assessed by the daily bowel habits diary

    Time frame: Baseline to Day 21

  10. Change in Bristol Stool Score

    Time frame: Baseline to Day 21

  11. Change in symptoms related to constipation determined by the Gastrointestinal Symptom Rating Scale

    Time frame: Baseline to Day 21

  12. Mean score of the Product Perception Questionnaire

    Time frame: Day 21

  13. The between group difference in the percentage of subjects that used a laxative

    Time frame: Baseline to Day 21

  14. The between group difference in the total number of days per subject that a laxative

    Time frame: Baseline to Day 21

Other outcomes

  1. Laboratory parameters of safety - CBC

    Time frame: Screening to Day 21

  2. Laboratory parameters of safety - Electrolytes

    Time frame: Screening to Day 21

  3. Laboratory parameters of safety - Kidney function markers

    Time frame: Screening to Day 21

  4. Laboratory parameters of safety - Liver function markers

    Time frame: Screening to Day 21

  5. Anthropometric measures - Weight

    Time frame: Screening to Day 21

  6. Anthropometric measures - BMI

    Time frame: Screening to Day 21

  7. Anthropometric measures - Blood Pressure

    Time frame: Screening to Day 21

  8. Anthropometric measures - Heart Rate

    Time frame: Screening to Day 21

  9. Incidence of Adverse Events

    Time frame: Baseline to Day 21

07

Study locations

1 site
  • KGK Synergize Inc.
    London, Ontario N6A 5R8, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2015 to primary completion in Apr 2016, 10 months.

Of 36 phase 2 interventional studies under Constipation, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2015
First posted
Apr 22, 2015
StartActual
Jun 12, 2015
Primary completionActual
Apr 12, 2016
CompletionActual
May 2016
Last update
Apr 11, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02423564
Lead sponsor
KGK Science Inc.
Collaborators
Global Institute of Probiotics
Responsible party
Sponsor
First posted
Apr 22, 2015
Start date
Jun 12, 2015
Primary completion
Apr 12, 2016
Completion
May 2016
Last update
Apr 11, 2018

Study contacts

Tetyana Pelipyagina, MD
principal investigator · KGK Science Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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