Probiotic Supplement for Digestive Health in Healthy Elderly

Recruiting in Palo Alto (17 mi)

Overseen byDavid Crowley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kaneka Americas Holding Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

This trial is for healthy older adults aged 50 to 85 with a BMI of 18.5-29.9, regular bowel movements, and no significant medical conditions or drug use that could affect the study. Women must not be able to bear children or agree to contraception; men's partners should have a vasectomy.

Inclusion Criteria

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)

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

You have less than or equal to 3 regular bowel movements per week.

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Exclusion Criteria

You have a condition that makes it difficult for your body to absorb nutrients properly.

Type I or type II diabetes or use of diabetes medication

Individuals who are cognitively impaired and/or who are unable to give informed consent

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Treatment Details

Interventions

Floradapt Mature Immune Defense (Probiotic)

Trial OverviewThe trial tests Floradapt Mature Immune Defense's impact on nutrient uptake and digestive health in elderly individuals over an 84-day period. Participants will take either this probiotic or a placebo alongside a multivitamin, complete questionnaires, and provide blood and saliva samples.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Floradapt Mature Immune DefenseActive Control1 Intervention

A multivitamin will also be consumed.

Group II: PlaceboPlacebo Group1 Intervention

A multivitamin will also be consumed.