A Study to Investigate the Safety and Efficacy of a Probiotic on Gastrointestinal Health in Healthy Adults

NCT04223388 | Unknown

• 1 other identifier: 19PGHC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Health; Healthy

Keywords

Probiotics; Healthy; Gut Health; Gastrointestinal Health

Outcome Measures

Primary Outcomes (3)

• 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

  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).

  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

  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

  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

  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

  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

  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

  14 days

Other Outcomes (27)

• Incidence of pre-emergent and post-emergent adverse events following 28-day supplementation

  28 days

• Change in systolic blood pressure following a 28-day supplementation

  28 days

• Change in diastolic blood pressure following a 28-day supplementation

  28 days

Study Arms (2)

Probiotic

EXPERIMENTAL

Dietary Supplement: Lactobacillus plantarum 276

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Lactobacillus plantarum 276 DIETARY_SUPPLEMENT

5 Billion CFU/dose, serving size = 1 capsule/day

Also known as: Lp276

Probiotic

Placebo OTHER

Placebo product, serving size = 1 capsule/day

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

RECRUITING

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mal Evans, PhD

CONTACT

5194389374; mevans@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel study

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: December 18, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)