A Study Investigating the Effect of Floradapt Mature Immune Defense on Nutrient Uptake and Digestive Health in a Healthy Elderly Population

NCT04147923 | Completed Phase 2

• 1 other identifier: 19ANHK
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Probiotic; Digestive Health; Healthy; Nutrient analysis; Constipation

Outcome Measures

Primary Outcomes (32)

• 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.

  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

Secondary Outcomes (14)

• 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

  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

Other Outcomes (24)

• 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

  84 days

• The change in diastolic blood pressure when supplemented for 84-days with either Floradapt Mature Immune Defense or placebo

  84 days

Study Arms (2)

Floradapt Mature Immune Defense

ACTIVE COMPARATOR

A multivitamin will also be consumed.

Dietary Supplement: Floradapt Mature Immune Defense + Multivitamin

Placebo

PLACEBO COMPARATOR

A multivitamin will also be consumed.

Dietary Supplement: Placebo + Multivitamin

Interventions

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.

Floradapt Mature Immune Defense

Placebo + Multivitamin DIETARY_SUPPLEMENT

No active ingredients + a multivitamin supplement

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 or milk
• Chronic constipation
• On prescribed laxatives
• Current or history of clinically significant diseases of the gastrointestinal tract (examples include but are not limited to atrophic gastritis, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease)
• Current or history of pancreatitis or short bowel syndrome
• Current or history of malabsorption assessed by the QI
• 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
• Current or history of hypertension but on a stable dose medication for ≥ 2 months will be reviewed on a case-by-case basis by the QI.
• Type I or type II diabetes or use of diabetes medication
• 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 kidney stone history in participants who are symptom free for 1 year

Sponsors & Collaborators

• Kaneka Americas Holding Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 40468693 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Geritol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: October 30, 2019
• First Posted: November 1, 2019
• Study Start: November 5, 2019
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)