CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Floradapt Mature Immune Defense + Multivitamin +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04147923
NCT04147923Phase 2Completed

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

Kaneka Americas Holding Inc.·interventional·Posted Nov 1, 2019·Updated May 8, 2024

In Brief

A Phase 2 clinical trial evaluating Floradapt Mature Immune Defense + Multivitamin and Placebo + Multivitamin for Healthy. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
CollaboratorsKGK Science Inc.

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 1, 2019
Enrollment StartNov 5, 2019
Primary CompletionJun 2, 2023
TodayJul 1, 2026
Enrollment to primary: 3.6 yearsPosted 6.7 years ago

Interventions

Floradapt Mature Immune Defense + Multivitamindietary

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

No active ingredients + a multivitamin supplement