Clinical trial NCT04223388: A Study to Investigate the Safety and Efficacy of a Probiotic on Gastrointestinal Health in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Health
Healthy
Keywords: Probiotics
Healthy
Gut Health
Gastrointestinal Health
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2020-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, parallel study
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Females and males between 18 to 55 years of age, inclusive
2. BMI between 18.5 to 32 kg/m2, inclusive
3. 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
4. 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)
5. Healthy as determined by laboratory results, medical history and physical exam by QI
6. Agrees to comply with all study procedures
7. Agrees to refrain from the use of any home remedies to control GI issues if live bacteria may be involved
8. Agrees to avoid NSAIDs and Steroids for 72 hours and Vitamin C and related supplements for 24 hours prior to fecal zonulin sample collection
9. Agrees to maintain current level of physical activity and diet throughout the study
10. Agrees to provide written informed consent

Exclusion Criteria:

1. Women who are pregnant, breast feeding, or planning to become pregnant during the trial
2. Allergy or sensitivity to investigational product's active or inactive ingredients
3. Clinically significant abnormal laboratory results at screening as assessed by QI
4. 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
5. Currently undergoing pharmacological treatment for IBS, or history of active treatment for IBS within the last 1 year
6. Clinically significant disease of the gastrointestinal tract (examples include but are not limited to celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease)
7. Gastrointestinal surgery within the past 3 months. Gastrointestinal surgery \> 3 months ago, will be assessed by the QI on a case-by-case basis.
8. 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
9. 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.
10. Verbal confirmation of autoimmune disease or if immune-compromised
11. Verbal confirmation of HIV, hepatitis B/C positive diagnosis
12. Metabolic syndrome or chronic diseases to be assessed by QI on a case by case basis
13. Type I or Type II diabetes
14. 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
15. 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
16. 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
17. Blood or bleeding disorders, with the exception of a history of anemia caused by deficiency of a mineral or vitamin, and no longer present
18. Current use or consumption of antibiotics in the 4 weeks prior to baseline
19. Current use or consumption of prebiotic or probiotic or synbiotic supplements in the 4 weeks prior to baseline
20. Current use of prescribed medications that may affect the study outcomes
21. 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
22. Use of medical marijuana
23. Chronic use of recreational marijuana; infrequent use (\>30 days since last use) to be assessed by QI
24. Use of tobacco products unless quit 90 days prior to baseline
25. Alcohol or drug abuse in the past year
26. High alcohol intake (average of \>2 standard drinks per day or \>10 standard drinks per week)
27. Use of narcotics
28. Illicit drug use in the past 6 months as assessed by the QI
29. Participation in other clinical research trials 30 days prior to randomization or will be participating in another investigation during the study
30. Participants who plan to donate blood during the study or within 30 days of completing the study
31. 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
32. 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

Primary outcomes:
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
timeFrame: 28 days
measure: 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
timeFrame: 28 days
measure: 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
timeFrame: 28 days
Secondary outcomes:
measure: 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
timeFrame: 7 days
measure: 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
timeFrame: 14 days
measure: 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
timeFrame: 21 days
measure: 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
timeFrame: 7 days
measure: 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
timeFrame: 14 days
measure: 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
timeFrame: 21 days
measure: 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
timeFrame: 7 days
measure: 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
timeFrame: 14 days
measure: 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
timeFrame: 21 days
measure: The change in fecal zonulin levels from baseline to day 7
timeFrame: 7 days
measure: The change in fecal zonulin levels from baseline to day 14
timeFrame: 14 days
measure: The change in fecal zonulin levels from baseline to day 21
timeFrame: 21 days
measure: The change in fecal zonulin levels from baseline to day 28
timeFrame: 28 days
measure: The change in fecal calprotectin levels from baseline to day 28
timeFrame: 28 days
measure: The change in probiotic impact questionaire from baseline to day 14
timeFrame: 14 days
measure: The change in probiotic impact questionaire from baseline to day 28
timeFrame: 28 days
measure: The change in fecal microbial composition from baseline to day 7
timeFrame: 7 days
measure: The change in fecal microbial composition from baseline to day 14
timeFrame: 14 days
measure: The change in fecal microbial composition from baseline to day 21
timeFrame: 21 days
measure: The change in fecal microbial composition from baseline to day 28
timeFrame: 28 days
Other outcomes:
measure: Incidence of pre-emergent and post-emergent adverse events following 28-day supplementation
timeFrame: 28 days
measure: Change in systolic blood pressure following a 28-day supplementation
timeFrame: 28 days
measure: Change in diastolic blood pressure following a 28-day supplementation
timeFrame: 28 days
measure: Change in heart rate following a 28-day supplementation
timeFrame: 28 days
measure: Change in alanine aminotransferase (ALT) levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in aspartate aminotransferase (AST) levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in total bilirubin levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in creatinine levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in sodium electrolyte levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in potassium electrolyte levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in chloride electrolyte levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in estimated glomerular filtration rate (eGFR) levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in white blood cell count following a 28-day supplementation
timeFrame: 28 days
measure: Change in neutrophil count following a 28-day supplementation
timeFrame: 28 days
measure: Change in lymphocyte count following a 28-day supplementation
timeFrame: 28 days
measure: Change in monocyte count following a 28-day supplementation
timeFrame: 28 days
measure: Change in eosinophil count following a 28-day supplementation
timeFrame: 28 days
measure: Change in basophil count following a 28-day supplementation
timeFrame: 28 days
measure: Change in red blood cell (RBC) count following a 28-day supplementation
timeFrame: 28 days
measure: Change in hemoglobin levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in hematocrit levels following a 28-day supplementation
timeFrame: 28 days
measure: Change in platelet count following a 28-day supplementation
timeFrame: 28 days
measure: Change in mean platelet volume (MPV) following a 28-day supplementation
timeFrame: 28 days
measure: Change in mean corpuscular volume (MCV) following a 28-day supplementation
timeFrame: 28 days
measure: Change in mean corpuscular hemoglobin (MCH) following a 28-day supplementation
timeFrame: 28 days
measure: Change in mean corpuscular hemoglobin concentration (MCHC) following a 28-day supplementation
timeFrame: 28 days
measure: Change in red cell distribution width (RDW) following a 28-day supplementation
timeFrame: 28 days
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: