Gastrointestinal HealthNCT04223388
A Study to Investigate the Safety and Efficacy of a Probiotic on Gastrointestinal Health in Healthy Adults
A study testing Lactobacillus plantarum 276 in people with Gastrointestinal Health and Healthy, run by Church & Dwight Company, Inc. at 1 site in Canada.
Trial summary
Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 28-days. Three check-in visits will occur every 7 days of study participation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Health, Healthy
- What is being tested?
- Lactobacillus plantarum 276
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 18 Dec 2019to Apr 2020
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario, N6A 5R8
Mal Evans, PhD, 5194389374, mevans@kgkscience.com
David Crowley, MD
About this study
Official title: 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
Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 28-days. Three check-in visits will occur every 7 days of study participation. Participants will be expected to complete a daily study diary documenting their investigational product use/adverse events and a daily bowel habits diary documenting each bowel movement. Blood samples, stool samples, and questionnaires will be completed for study outcome analysis.
- Conditions
- Gastrointestinal Health, Healthy
- Being tested
- Lactobacillus plantarum 276, Placebo
- Keywords
- Probiotics, Healthy, Gut Health, Gastrointestinal Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum 276Dietary supplement
Also called Lp276
5 Billion CFU/dose, serving size = 1 capsule/day
PlaceboOther
Placebo product, serving size = 1 capsule/day
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Not described Receives: Dietary Supplement: Lactobacillus plantarum 276 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Number of bowel movements per day will be assessed in the bowel habits diary
Measured: 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
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).
Measured: 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
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
Measured: 28 days
Secondary outcomes (20)
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
Number of bowel movements per day will be assessed in the bowel habits diary
Measured: 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
Number of bowel movements per day will be assessed in the bowel habits diary
Measured: 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
Number of bowel movements per day will be assessed in the bowel habits diary
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 21 days
The change in fecal zonulin levels from baseline to day 7
Zonulin levels will be analysed from stool samples. A decrease in zonulin levels are associated with better intestinal health.
Measured: 7 days
The change in fecal zonulin levels from baseline to day 14
Zonulin levels will be analysed from stool samples. A decrease in zonulin levels are associated with better intestinal health.
Measured: 14 days
The change in fecal zonulin levels from baseline to day 21
Zonulin levels will be analysed from stool samples. A decrease in zonulin levels are associated with better intestinal health.
Measured: 21 days
The change in fecal zonulin levels from baseline to day 28
Zonulin levels will be analysed from stool samples. A decrease in zonulin levels are associated with better intestinal health.
Measured: 28 days
The change in fecal calprotectin levels from baseline to day 28
Calprotectin levels will be analysed from stool samples. A decrease in calprotectin levels are associated with better intestinal health.
Measured: 28 days
The change in probiotic impact questionaire from baseline to day 14
This 22-item questionnaire was specifically designed capture the impact of Lactobacillus plantarum 276 (Lp276) on participants health
Measured: 14 days
The change in probiotic impact questionaire from baseline to day 28
This 22-item questionnaire was specifically designed capture the impact of Lactobacillus plantarum 276 (Lp276) on participants health
Measured: 28 days
The change in fecal microbial composition from baseline to day 7
Microbial composition will be analysed from stool samples
Measured: 7 days
The change in fecal microbial composition from baseline to day 14
Microbial composition will be analysed from stool samples
Measured: 14 days
The change in fecal microbial composition from baseline to day 21
Microbial composition will be analysed from stool samples
Measured: 21 days
The change in fecal microbial composition from baseline to day 28
Microbial composition will be analysed from stool samples
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start18 Dec 2019
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HealthStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223388
- Sponsor's protocol ID
- 19PGHC
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04223388
- Acronym / sponsor ID
- 19PGHC
- Conditions
- Gastrointestinal Health, Healthy
- Keywords
- Probiotics, Healthy, Gut Health, Gastrointestinal Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 10 Jan 2020 (actual)
- 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.
Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 28-days. Three check-in visits will occur every 7 days of study participation. Participants will be expected to complete a daily study diary documenting their investigational product use/adverse events and a daily bowel habits diary documenting each bowel movement. Blood samples, stool samples, and questionnaires will be completed for study outcome analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel study
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Lactobacillus plantarum 276 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (32 listed)
- 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
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 |
|---|---|---|
| Lactobacillus plantarum 276Also: Lp2765 Billion CFU/dose, serving size = 1 capsule/day | Dietary supplement | Probiotic |
| PlaceboPlacebo product, serving size = 1 capsule/day | Other | Placebo |
Primary outcome
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
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).
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
20 secondary outcomes
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
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
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
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
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
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
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 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 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 change in fecal zonulin levels from baseline to day 7
Time frame: 7 days
The change in fecal zonulin levels from baseline to day 14
Time frame: 14 days
The change in fecal zonulin levels from baseline to day 21
Time frame: 21 days
The change in fecal zonulin levels from baseline to day 28
Time frame: 28 days
The change in fecal calprotectin levels from baseline to day 28
Time frame: 28 days
The change in probiotic impact questionaire from baseline to day 14
Time frame: 14 days
The change in probiotic impact questionaire from baseline to day 28
Time frame: 28 days
The change in fecal microbial composition from baseline to day 7
Time frame: 7 days
The change in fecal microbial composition from baseline to day 14
Time frame: 14 days
The change in fecal microbial composition from baseline to day 21
Time frame: 21 days
The change in fecal microbial composition from baseline to day 28
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: No
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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.
David Crowley, 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 study testing Lactobacillus plantarum 276 in people with Gastrointestinal Health and Healthy, run by Church & Dwight Company, 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 12 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 10 Jan 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mal Evans, PhD (5194389374, mevans@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. 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 10 Jan 2020.