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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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This trial will be investigating the effect for Floradapt Mature Immune Defense on nutrient uptake and digestive health in a healthy elderly population. Approximately 120 healthy older adults will be enrolled into the study and will consume either the probiotic or placebo supplement for 84 days and complete questionnaires as well as provide blood samples for nutrient uptake analysis (for 50 participants), immunological markers, and general markers of health. Saliva samples will be provided for analysis of sIgA and cortisol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Floradapt Mature Immune Defense | Active Comparator | A multivitamin will also be consumed. |
|
| Placebo | Placebo Comparator | A multivitamin will also be consumed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Floradapt Mature Immune Defense + Multivitamin | Dietary Supplement | The product consists of two L. plantarum strains, KABP XXXX and KABP XXXX with a combined strength of >1 x 10^9 CFU. Participants will also consume a multivitamin. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in digestive health as assessed by Gastrointestinal Symptoms Rating Scale (GSRS) | 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 4-point scale where 0 represented no symptoms and 3 represented severe symptoms. A lower score represents less symptoms. | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in digestive health as assessed by Gastrointestinal Symptoms Rating Scale (GSRS) | 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 4-point scale where 0 represented no symptoms and 3 represented severe symptoms. A lower score represents less symptoms. | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in bowel movements and stool consistency as assessed by daily bowel habits diary | The Bowel Habit Diary consisted of a 7 items questionnaire for evaluating each bowel movement. Bristol Stool Scale is a seven-stool description and image scale within the Daily Bowel Habit Diary to assess stool shape and consistency (type 1 is separate hard lumps, where type 7 is watery stools with no solid pieces). Stool consistency is a bowel function indicator due to its correlation with colonic transit time. |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline to day 84 between Floradapt Mature Immune Defense and placebo in quality of life (QoL) assessed by the SF-12v2 questionnaire | 84 days | |
| The change from baseline to day 84 between Floradapt Mature Immune Defense and placebo in quality of life (QoL) assessed by Perceived Stress test |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pre-emergent and post-emergent adverse events following 84-day between Floradapt Mature Immune Defense and placebo supplementation | 84 days | |
| The change in systolic blood pressure when supplemented for 84-days with either Floradapt Mature Immune Defense or placebo |
Inclusion Criteria:
Males or females age 50 to 85 years, inclusive
BMI 18.5-29.9 kg/m2, inclusive
Participants must meet the following criteria regarding their bowel habits. This will be assessed at screening and confirmed at baseline:
I. ≤ 5 complete BMs per week AND at least 25% of BMs are BSS type 1 or 2 collectively with excessive straining for most of the BMs (≥50%), defined as 3 minutes or more during BM, as assessed by the QI OR, II. At least 50% of bowel movements are Bristol Stool Scale (BSS) type 1 and 2 at screening and confirmed at baseline as assessed by the QI OR, III. ≤ 3 complete spontaneous BMs per week as assessed by the QI
Female participant is not of child bearing potential, which is defined as females who have had a hysterectomy or bilateral oophorectomy, complete endometrial ablation, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR,
Females of child-bearing potential must have a negative urine pregnancy test at screening and baseline and must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. 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)
Albumin levels at screening between 25-50 g/L, inclusive. If albumin level <35 g/L all other liver function tests must be within the normal range.
Healthy as determined by laboratory results, medical history, and physical exam by QI
Agrees to comply with all study procedures
Agrees to maintain current level of physical activity and diet throughout the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6A 5R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40468693 | Derived | Singh RG, Aoki F, Rodriguez-Palmero Seuma M, Aguilo M, Washida M, Espadaler-Mazo J, Al-Wahsh H, Crowley DC, Guthrie N, Evans M, Moulin M, Lewis ED. Efficacy of Probiotic Supplementation with Lactiplantibacillus plantarum Strains on Gastrointestinal Tract Function - A Randomized Controlled Trial. J Diet Suppl. 2025;22(4):549-570. doi: 10.1080/19390211.2025.2507610. Epub 2025 Jun 4. |
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Randomized, double-blind, placebo-controlled, parallel study
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| Placebo + Multivitamin | Dietary Supplement | No active ingredients + a multivitamin supplement |
|
| 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in bowel movements and stool consistency as assessed by daily bowel habits diary | The Bowel Habit Diary consisted of a 7 items questionnaire for evaluating each bowel movement. Bristol Stool Scale is a seven-stool description and image scale within the Daily Bowel Habit Diary to assess stool shape and consistency (type 1 is separate hard lumps, where type 7 is watery stools with no solid pieces). Stool consistency is a bowel function indicator due to its correlation with colonic transit time. | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of albumin | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of albumin | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of total protein | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of total protein | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin A | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin A | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin B12 | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin B12 | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Folate | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Folate | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin C | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin C | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin D | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin D | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin E | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Vitamin E | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Calcium | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Calcium | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Iron | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Iron | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Magnesium | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing serum levels of Magnesium | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing plasma levels of Vitamin B6 | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing plasma levels of Vitamin B6 | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing plasma levels of Zinc | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing plasma levels of Zinc | 84 days |
| The changes from baseline to day 42 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing plasma levels of CoQ10 | 42 days |
| The changes from baseline to day 84 between Floradapt Mature Immune Defense and placebo in nutrient uptake as determined by analyzing plasma levels of CoQ10 | 84 days |
| 84 days |
| The changes in plasma immunological marker CD4+from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation | 42 days |
| The changes in plasma immunological marker CD4+from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation | 84 days |
| The changes in plasma immunological marker CD8+from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation | 42 days |
| The changes in plasma immunological marker CD8+from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation | 84 days |
| The changes in plasma immunological marker CD19+ from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation | 42 days |
| The changes in plasma immunological marker CD19+ from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation | 84 days |
| The changes in plasma immunological marker CD56+ from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation | 42 days |
| The changes in plasma immunological marker CD56+ from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation | 84 days |
| The changes in saliva immunological marker sIgA from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation | 42 days |
| The changes in saliva immunological marker sIgA from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation | 84 days |
| The changes in saliva immunological marker cortisol from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation | 42 days |
| The changes in saliva immunological marker cortisol from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation | 84 days |
| 84 days |
| The change in diastolic blood pressure when supplemented for 84-days with either Floradapt Mature Immune Defense or placebo | 84 days |
| The change in heart rate when supplemented for 84-days with either Floradapt Mature Immune Defense or placebo | 84 days |
| The change in alanine aminotransferase (ALT) following 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in aspartate aminotransferase (AST) following 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in total bilirubin following 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in creatinine following 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in electrolytes following 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in estimated glomerular filtration rate (eGFR) following 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in neutrophils after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in lymphocytes after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in monocytes after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in eosinophils after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in basophils after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in red blood cell (RBC) count after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in hemoglobin levels after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in hematocrit levels after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in platelet count after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in mean corpuscular volume (MCV) after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in mean corpuscular hemoglobin (MCH) after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in mean corpuscular hemoglobin concentration (MCHC) after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in mean platelet volume (MPV) after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| The change in red cell distribution width (RDW) after 84-day supplementation with Floradapt Mature Immune Defense or placebo | 84 days |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C067316 | Geritol |
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