- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04223388
A Study to Investigate the Safety and Efficacy of a Probiotic on Gastrointestinal Health in Healthy Adults
A Randomized, Double-blind, Placebo-controlled, Parallel, Research Study to Investigate the Safety and Efficacy of a Probiotic Lactobacillus Plantarum 276 (Lp276) on Gastrointestinal Health in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mal Evans, PhD
- Phone Number: 5194389374
- Email: mevans@kgkscience.com
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5R8
- Recruiting
- KGK Science Inc.
-
Contact:
- Mal Evans, PhD
- Phone Number: 5194389374
- Email: mevans@kgkscience.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Females and males between 18 to 55 years of age, inclusive
- BMI between 18.5 to 32 kg/m2, inclusive
- Self-reported history of diarrhea over the last 3 months, defined as > 5 BMs with the majority (≥ 50%) of the BMs per week being Bristol stool form types ≥5, 6 or 7
Female participant is not of child bearing potential, which is defined as females who have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation, or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR,
Females of childbearing potential must agree to use a medically approved method of birth control and must have negative urine pregnancy test results at screening and baseline. A minimum of 3-months stable dose is required for females on a hormonal birth control. Acceptable methods of birth control include:
I. 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) II. Double-barrier method III. Intrauterine devices IV. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) V. Vasectomy of partner (shown successful as per appropriate follow-up)
- Healthy as determined by laboratory results, medical history and physical exam by QI
- Agrees to comply with all study procedures
- Agrees to refrain from the use of any home remedies to control GI issues if live bacteria may be involved
- Agrees to avoid NSAIDs and Steroids for 72 hours and Vitamin C and related supplements for 24 hours prior to fecal zonulin sample collection
- Agrees to maintain current level of physical activity and diet throughout the study
- Agrees to provide written informed consent
Exclusion Criteria:
- Women who are pregnant, breast feeding, or planning to become pregnant during the trial
- Allergy or sensitivity to investigational product's active or inactive ingredients
- Clinically significant abnormal laboratory results at screening as assessed by QI
- Chronic use of anti-diarrhea medications and supplements; occasional use is permitted based on frequency of use and appropriate wash-out to be determined by QI
- Currently undergoing pharmacological treatment for IBS, or history of active treatment for IBS within the last 1 year
- Clinically significant disease of the gastrointestinal tract (examples include but are not limited to celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease)
- Gastrointestinal surgery within the past 3 months. Gastrointestinal surgery > 3 months ago, will be assessed by the QI on a case-by-case basis.
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Minor surgery will be considered on a case by case basis by QI
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Cancer in full remission for more than five years after diagnosis are acceptable.
- Verbal confirmation of autoimmune disease or if immune-compromised
- Verbal confirmation of HIV, hepatitis B/C positive diagnosis
- Metabolic syndrome or chronic diseases to be assessed by QI on a case by case basis
- Type I or Type II diabetes
- Significant cardiovascular event in the past 6 months. No significant cardiovascular event on stable medication may be included after assessment by the QI on a case by case basis
- History or currently with kidney and liver diseases assessed by QI on a case by case basis, with the exception of the history of kidney stones symptom-free for 1 year
- Verbal confirmation of current or pre-existing thyroid condition. Treatment on a stable dose medication for over 6 months will be reviewed on a case-by-case basis by the QI
- Blood or bleeding disorders, with the exception of a history of anemia caused by deficiency of a mineral or vitamin, and no longer present
- Current use or consumption of antibiotics in the 4 weeks prior to baseline
- Current use or consumption of prebiotic or probiotic or synbiotic supplements in the 4 weeks prior to baseline
- Current use of prescribed medications that may affect the study outcomes
- Use of over-the-counter (OTC) medications or supplements or consumption of foods/drinks that may affect the study outcomes, unless willing to undergo an appropriate washout period prior to baseline is agreed upon after assessment by the QI
- Use of medical marijuana
- Chronic use of recreational marijuana; infrequent use (>30 days since last use) to be assessed by QI
- Use of tobacco products unless quit 90 days prior to baseline
- Alcohol or drug abuse in the past year
- High alcohol intake (average of >2 standard drinks per day or >10 standard drinks per week)
- Use of narcotics
- Illicit drug use in the past 6 months as assessed by the QI
- Participation in other clinical research trials 30 days prior to randomization or will be participating in another investigation during the study
- Participants who plan to donate blood during the study or within 30 days of completing the study
- Any known (choric or acute) medical or neuropsychological condition that, in the QI's opinion, could interfere with study participation, or individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo product, serving size = 1 capsule/day
|
Experimental: Probiotic
|
5 Billion CFU/dose, serving size = 1 capsule/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference between probiotic and placebo groups in the change in gastrointestinal health from baseline to day 28 as determined by stool frequency as per daily bowel habit diary
Time Frame: 28 days
|
Number of bowel movements per day will be assessed in the bowel habits diary
|
28 days
|
The difference between probiotic and placebo groups in the change in gastrointestinal health from baseline to day 28 as determined by stool consistency as per the Bristol Stool Scale
Time Frame: 28 days
|
Bristol Stool Scale is a seven-stool description and image scale within the Daily Bowel Habit Diary to assess stool shape and consistency (1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = like a sausage but with cracks on its surface, 4 = like a sausage or snake, smooth and soft, 5 = soft blobs with clear-cut edges, 6 = fluffy pieces with ragged edges/mushy stool, 7 = watery, no solid pieces).
|
28 days
|
The difference between probiotic and placebo groups in the change in gastrointestinal health from baseline to day 28 as determined by gastrointestinal (GI) symptoms as per the gastrointestinal symptom rating scale
Time Frame: 28 days
|
The GSRS is a validated, self-assessed, disease-specific scale that will be administered at all in-clinic visits.
Five symptom clusters depicted as Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation will be assessed from the combination of the 15 items in the questionnaire (Abdominal pains, Heartburn, Acid regurgitation, Sucking sensations in the epigastrium, Nausea and vomiting, Borborygmus, Abdominal distension, Eructation, Increased flatus, Decreased passage of stools, Increased passage of stools, Loose stools, Hard Stools, Urgent need for defecation, Feeling of incomplete evacuation).
All the domains will be scored on a 3-point scale where 1 represented no symptoms and 3 represented severe symptoms
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference between probiotic and placebo groups in gastrointestinal health from baseline to day 7 as determined by stool frequency as per the daily bowel habits diary
Time Frame: 7 days
|
Number of bowel movements per day will be assessed in the bowel habits diary
|
7 days
|
The difference between probiotic and placebo groups in gastrointestinal health from baseline to day 14 as determined by stool frequency as per the daily bowel habits diary
Time Frame: 14 days
|
Number of bowel movements per day will be assessed in the bowel habits diary
|
14 days
|
The difference between probiotic and placebo groups in gastrointestinal health from baseline to day 21 as determined by stool frequency as per the daily bowel habits diary
Time Frame: 21 days
|
Number of bowel movements per day will be assessed in the bowel habits diary
|
21 days
|
The difference between probiotic and placebo groups in gastrointestinal health from baseline to day 7 as determined by stool consistency as per the Bristol Stool Scale
Time Frame: 7 days
|
Bristol Stool Scale is a seven-stool description and image scale within the Daily Bowel Habit Diary to assess stool shape and consistency (1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = like a sausage but with cracks on its surface, 4 = like a sausage or snake, smooth and soft, 5 = soft blobs with clear-cut edges, 6 = fluffy pieces with ragged edges/mushy stool, 7 = watery, no solid pieces).
|
7 days
|
The difference between probiotic and placebo groups in gastrointestinal health from baseline to day 14 as determined by stool consistency as per the Bristol Stool Scale
Time Frame: 14 days
|
Bristol Stool Scale is a seven-stool description and image scale within the Daily Bowel Habit Diary to assess stool shape and consistency (1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = like a sausage but with cracks on its surface, 4 = like a sausage or snake, smooth and soft, 5 = soft blobs with clear-cut edges, 6 = fluffy pieces with ragged edges/mushy stool, 7 = watery, no solid pieces).
|
14 days
|
The difference between probiotic and placebo groups in gastrointestinal health from baseline to day 21 as determined by stool consistency as per the Bristol Stool Scale
Time Frame: 21 days
|
Bristol Stool Scale is a seven-stool description and image scale within the Daily Bowel Habit Diary to assess stool shape and consistency (1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = like a sausage but with cracks on its surface, 4 = like a sausage or snake, smooth and soft, 5 = soft blobs with clear-cut edges, 6 = fluffy pieces with ragged edges/mushy stool, 7 = watery, no solid pieces).
|
21 days
|
The difference between probiotic and placebo groups in gastrointestinal health from baseline to day 7 as determined by gastrointestinal symptoms as per the Gastrointestinal Symptom Rating Scale
Time Frame: 7 days
|
The GSRS is a validated, self-assessed, disease-specific scale that will be administered at all in-clinic visits.
Five symptom clusters depicted as Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation will be assessed from the combination of the 15 items in the questionnaire (Abdominal pains, Heartburn, Acid regurgitation, Sucking sensations in the epigastrium, Nausea and vomiting, Borborygmus, Abdominal distension, Eructation, Increased flatus, Decreased passage of stools, Increased passage of stools, Loose stools, Hard Stools, Urgent need for defecation, Feeling of incomplete evacuation).
All the domains will be scored on a 3-point scale where 1 represented no symptoms and 3 represented severe symptoms
|
7 days
|
The difference between probiotic and placebo groups in gastrointestinal health from baseline to day 14 as determined by gastrointestinal symptoms as per the Gastrointestinal Symptom Rating Scale
Time Frame: 14 days
|
The GSRS is a validated, self-assessed, disease-specific scale that will be administered at all in-clinic visits.
Five symptom clusters depicted as Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation will be assessed from the combination of the 15 items in the questionnaire (Abdominal pains, Heartburn, Acid regurgitation, Sucking sensations in the epigastrium, Nausea and vomiting, Borborygmus, Abdominal distension, Eructation, Increased flatus, Decreased passage of stools, Increased passage of stools, Loose stools, Hard Stools, Urgent need for defecation, Feeling of incomplete evacuation).
All the domains will be scored on a 3-point scale where 1 represented no symptoms and 3 represented severe symptoms
|
14 days
|
The difference between probiotic and placebo groups in gastrointestinal health from baseline to day 21 as determined by gastrointestinal symptoms as per the Gastrointestinal Symptom Rating Scale
Time Frame: 21 days
|
The GSRS is a validated, self-assessed, disease-specific scale that will be administered at all in-clinic visits.
Five symptom clusters depicted as Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation will be assessed from the combination of the 15 items in the questionnaire (Abdominal pains, Heartburn, Acid regurgitation, Sucking sensations in the epigastrium, Nausea and vomiting, Borborygmus, Abdominal distension, Eructation, Increased flatus, Decreased passage of stools, Increased passage of stools, Loose stools, Hard Stools, Urgent need for defecation, Feeling of incomplete evacuation).
All the domains will be scored on a 3-point scale where 1 represented no symptoms and 3 represented severe symptoms
|
21 days
|
The change in fecal zonulin levels from baseline to day 7
Time Frame: 7 days
|
Zonulin levels will be analysed from stool samples.
A decrease in zonulin levels are associated with better intestinal health.
|
7 days
|
The change in fecal zonulin levels from baseline to day 14
Time Frame: 14 days
|
Zonulin levels will be analysed from stool samples.
A decrease in zonulin levels are associated with better intestinal health.
|
14 days
|
The change in fecal zonulin levels from baseline to day 21
Time Frame: 21 days
|
Zonulin levels will be analysed from stool samples.
A decrease in zonulin levels are associated with better intestinal health.
|
21 days
|
The change in fecal zonulin levels from baseline to day 28
Time Frame: 28 days
|
Zonulin levels will be analysed from stool samples.
A decrease in zonulin levels are associated with better intestinal health.
|
28 days
|
The change in fecal calprotectin levels from baseline to day 28
Time Frame: 28 days
|
Calprotectin levels will be analysed from stool samples.
A decrease in calprotectin levels are associated with better intestinal health.
|
28 days
|
The change in probiotic impact questionaire from baseline to day 14
Time Frame: 14 days
|
This 22-item questionnaire was specifically designed capture the impact of Lactobacillus plantarum 276 (Lp276) on participants health
|
14 days
|
The change in probiotic impact questionaire from baseline to day 28
Time Frame: 28 days
|
This 22-item questionnaire was specifically designed capture the impact of Lactobacillus plantarum 276 (Lp276) on participants health
|
28 days
|
The change in fecal microbial composition from baseline to day 7
Time Frame: 7 days
|
Microbial composition will be analysed from stool samples
|
7 days
|
The change in fecal microbial composition from baseline to day 14
Time Frame: 14 days
|
Microbial composition will be analysed from stool samples
|
14 days
|
The change in fecal microbial composition from baseline to day 21
Time Frame: 21 days
|
Microbial composition will be analysed from stool samples
|
21 days
|
The change in fecal microbial composition from baseline to day 28
Time Frame: 28 days
|
Microbial composition will be analysed from stool samples
|
28 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of pre-emergent and post-emergent adverse events following 28-day supplementation
Time Frame: 28 days
|
28 days
|
|
Change in systolic blood pressure following a 28-day supplementation
Time Frame: 28 days
|
28 days
|
|
Change in diastolic blood pressure following a 28-day supplementation
Time Frame: 28 days
|
28 days
|
|
Change in heart rate following a 28-day supplementation
Time Frame: 28 days
|
28 days
|
|
Change in alanine aminotransferase (ALT) levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in aspartate aminotransferase (AST) levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in total bilirubin levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in creatinine levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in sodium electrolyte levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in potassium electrolyte levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in chloride electrolyte levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in estimated glomerular filtration rate (eGFR) levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in white blood cell count following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in neutrophil count following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in lymphocyte count following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in monocyte count following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in eosinophil count following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in basophil count following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in red blood cell (RBC) count following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in hemoglobin levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in hematocrit levels following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in platelet count following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in mean platelet volume (MPV) following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in mean corpuscular volume (MCV) following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in mean corpuscular hemoglobin (MCH) following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in mean corpuscular hemoglobin concentration (MCHC) following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Change in red cell distribution width (RDW) following a 28-day supplementation
Time Frame: 28 days
|
Analysed from blood
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19PGHC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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