Occasional ConstipationPhase 2NCT02423564
A Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation
A Phase 2 study testing Digesta Lac in people with Occasional Constipation, run by KGK Science Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Occasional Constipation
- What is being tested?
- Digesta Lac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2015to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Parallel Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation
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
- Being tested
- Digesta Lac, Placebo
- Keywords
- Probiotic, Digesta-Lac, Occasional Constipation, Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digesta LacDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements
Measured: Baseline to Day 21
Secondary outcomes (14)
The between group difference in the average number of weekly complete spontaneous bowel movements
Measured: Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly complete spontaneous bowel movements
Measured: Day 21
The mean difference (probiotic - placebo) in the number of weekly spontaneous bowel movements
Measured: Baseline to Day 21
The between group difference in the average number of weekly spontaneous bowel movements
Measured: Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly spontaneous bowel movements
Measured: Day 21
The mean difference (probiotic - placebo) in the number of weekly bowel movements
Measured: Baseline to Day 21
The between group difference in the average number of weekly bowel movements
Measured: Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly bowel movements
Measured: Day 21
Changes in bowel habits (straining, feeling of complete evacuation) as assessed by the daily bowel habits diary
Measured: Baseline to Day 21
Change in Bristol Stool Score
Measured: Baseline to Day 21
Change in symptoms related to constipation determined by the Gastrointestinal Symptom Rating Scale
Measured: Baseline to Day 21
Mean score of the Product Perception Questionnaire
Measured: Day 21
The between group difference in the percentage of subjects that used a laxative
Measured: Baseline to Day 21
The between group difference in the total number of days per subject that a laxative
Measured: Baseline to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start12 Jun 2015
- Primary completion12 Apr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occasional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global Institute of Probiotics
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423564
- Sponsor's protocol ID
- 14PCHN
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2015
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Parallel Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation
- ClinicalTrials.gov ID
- NCT02423564
- Acronym / sponsor ID
- 14PCHN
- Conditions
- Occasional Constipation
- Keywords
- Probiotic, Digesta-Lac, Occasional Constipation, Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Global Institute of Probiotics
- Study start
- 12 Jun 2015 (actual)
- Primary completion
- 12 Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Population with Digesta Lac | Active comparator | Dietary Supplement: Digesta LacDigesta 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) |
| Healthy Population with Placebo | Placebo comparator | Other: PlaceboPlacebo contains: cellulose, Organic Whole Grain Brown Rice Milk Concentrate, L-Leucine, potato powder, vegetable capsule (hypromellose) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digesta Lac | Dietary supplement | Healthy Population with Digesta Lac |
| Placebo | Other | Healthy Population with Placebo |
Primary outcome
Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements
Time frame: Baseline to Day 21
14 secondary outcomes
The between group difference in the average number of weekly complete spontaneous bowel movements
Time frame: Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly complete spontaneous bowel movements
Time frame: Day 21
The mean difference (probiotic - placebo) in the number of weekly spontaneous bowel movements
Time frame: Baseline to Day 21
The between group difference in the average number of weekly spontaneous bowel movements
Time frame: Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly spontaneous bowel movements
Time frame: Day 21
The mean difference (probiotic - placebo) in the number of weekly bowel movements
Time frame: Baseline to Day 21
The between group difference in the average number of weekly bowel movements
Time frame: Baseline to Day 21
The percentage of responders vs. non- responders for the average number of weekly bowel movements
Time frame: Day 21
Changes in bowel habits (straining, feeling of complete evacuation) as assessed by the daily bowel habits diary
Time frame: Baseline to Day 21
Change in Bristol Stool Score
Time frame: Baseline to Day 21
Change in symptoms related to constipation determined by the Gastrointestinal Symptom Rating Scale
Time frame: Baseline to Day 21
Mean score of the Product Perception Questionnaire
Time frame: Day 21
The between group difference in the percentage of subjects that used a laxative
Time frame: Baseline to Day 21
The between group difference in the total number of days per subject that a laxative
Time frame: Baseline to Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
Related trials for Occasional Constipation
Not yet recruiting
A Clinical Trial to Investigate the Efficacy of Acacia Fiber on Gastrointestinal Health and Microbiota Composition in Healthy Adults With Occasional Constipation
Occasional Constipation, Gastrointestinal Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetyana Pelipyagina, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Digesta Lac in people with Occasional Constipation, run by KGK Science Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference (probiotic - placebo) in the number of weekly complete spontaneous bowel movements (time frame: Baseline to Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.