HealthyPhase 2NCT04147923
A Study Investigating the Effect of Floradapt Mature Immune Defense on Nutrient Uptake and Digestive Health in a Healthy Elderly Population
A Phase 2 study testing Floradapt Mature Immune Defense + Multivitamin in people with Healthy, run by Kaneka Americas Holding Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Floradapt Mature Immune Defense + Multivitamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2019to 2 Jun 2023
- Phase
- Phase 2
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- ≤ 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:
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- 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
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 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
Show all 36Show fewer
- 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
- Verbal confirmation of current or pre-existing thyroid condition. Treatment on a stable dose medication for over 3 months will be reviewed on a case-by-case basis by the QI
- Difficulties swallowing medications
- Verbal confirmation of bleeding disorder
- Blood disorders as determined by laboratory results
- Acute or chronic illness of concern to the QI
- Clinically significant abnormal laboratory results at screening as assessed by QI
- Current use of blood thinners, with the exception of ASA 81 mg or less
- Current use of prescribed medications that may cause constipation or affect the study outcomes as assessed by QI
- 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.
- Medicinal use of marijuana
- Recreational use of marijuana, unless willing to undergo a 30-day washout prior to baseline
- Alcohol or drug abuse (< 1 year)
- High alcohol intake (average of >2 standar3d 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
- Current uses of tobacco or related products unless cessation 60 days prior to baseline
- Blood donation during or within 30 days following conclusion of clinical trial
- Participation in a clinical research trial within 30 days prior to enrollment will be assessed case-by-case by the QI
- Verbal confirmation of dementia or known neuropsychological condition that, in the QI's opinion, could interfere with study participation.
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other chronic or 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 significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Effect of Floradapt Mature Immune Defense on Nutrient Uptake and Digestive Health in a Healthy Elderly Population
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
- Being tested
- Floradapt Mature Immune Defense + Multivitamin, Placebo + Multivitamin
- Keywords
- Probiotic, Digestive Health, Healthy, Nutrient analysis, Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floradapt Mature Immune Defense + MultivitaminDietary 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.
Placebo + MultivitaminDietary supplement
No active ingredients + a multivitamin supplement
| Study group | Role | What they receive |
|---|---|---|
| Floradapt Mature Immune Defense | Active comparator | A multivitamin will also be consumed. Receives: Dietary Supplement: Floradapt Mature Immune Defense + Multivitamin |
| Placebo | Placebo comparator | A multivitamin will also be consumed. Receives: Dietary Supplement: Placebo + Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 84 days
The changes in plasma immunological marker CD4+from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 42 days
The changes in plasma immunological marker CD4+from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 84 days
The changes in plasma immunological marker CD8+from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 42 days
The changes in plasma immunological marker CD8+from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 84 days
The changes in plasma immunological marker CD19+ from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 42 days
The changes in plasma immunological marker CD19+ from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 84 days
The changes in plasma immunological marker CD56+ from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 42 days
The changes in plasma immunological marker CD56+ from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 84 days
The changes in saliva immunological marker sIgA from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 42 days
The changes in saliva immunological marker sIgA from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 84 days
The changes in saliva immunological marker cortisol from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 42 days
The changes in saliva immunological marker cortisol from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start5 Nov 2019
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 2
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaneka Americas Holding 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
- NCT04147923
- Sponsor's protocol ID
- 19ANHK
- Status last verified
- Jan 2024
- First submitted
- 30 Oct 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40468693
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Effect of Floradapt Mature Immune Defense on Nutrient Uptake and Digestive Health in a Healthy Elderly Population
- ClinicalTrials.gov ID
- NCT04147923
- Acronym / sponsor ID
- 19ANHK
- Conditions
- Healthy
- Keywords
- Probiotic, Digestive Health, Healthy, Nutrient analysis, Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kaneka Americas Holding Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 1 Nov 2019 (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.
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.
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 |
|---|---|---|
| Floradapt Mature Immune Defense | Active comparator | Dietary Supplement: Floradapt Mature Immune Defense + MultivitaminA multivitamin will also be consumed. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo + MultivitaminA multivitamin will also be consumed. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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:
Key exclusion criteria (36 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 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)
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 |
|---|---|---|
| Floradapt Mature Immune Defense + MultivitaminThe 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. | Dietary supplement | Floradapt Mature Immune Defense |
| Placebo + MultivitaminNo active ingredients + a multivitamin supplement | Dietary supplement | Placebo |
Primary outcome
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)
Time frame: 42 days
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.
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)
Time frame: 84 days
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.
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
Time frame: 42 days
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.
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
Time frame: 84 days
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 84 days
14 secondary outcomes
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
Time frame: 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
Time frame: 84 days
The changes in plasma immunological marker CD4+from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 42 days
The changes in plasma immunological marker CD4+from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 84 days
The changes in plasma immunological marker CD8+from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 42 days
The changes in plasma immunological marker CD8+from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 84 days
The changes in plasma immunological marker CD19+ from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 42 days
The changes in plasma immunological marker CD19+ from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 84 days
The changes in plasma immunological marker CD56+ from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 42 days
The changes in plasma immunological marker CD56+ from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 84 days
The changes in saliva immunological marker sIgA from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 42 days
The changes in saliva immunological marker sIgA from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 84 days
The changes in saliva immunological marker cortisol from baseline to day 42 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 42 days
The changes in saliva immunological marker cortisol from baseline to day 84 between Floradapt Mature Immune Defense and placebo supplementation
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 40468693Singh 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.
- 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 Phase 2 study testing Floradapt Mature Immune Defense + Multivitamin in people with Healthy, run by Kaneka Americas Holding 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 11 inclusion and 36 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: finished, as of the sponsor's last update on 8 May 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 42 days). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04147923, which also lists 1 linked publication.
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 8 May 2024.