Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly

Gabriella C. van Zanten

Status and phase

Completed

Early Phase 1

Conditions

Fecal Metabolome

Gut Microbiota

Elderly

Clostridium Difficile

Probiotics

Treatments

Dietary Supplement: HOWARU Restore

Study type

Interventional

Funder types

Other

Identifiers

NCT02207140

DKID H-1-2014-051

H-1-2014-051 (Other Identifier)

Details and patient eligibility

About

The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks. Following randomization, healthy elderly are randomized into two groups receiving probiotics or placebo. Fecal samples are collected before and after the study. The samples are investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as well changes in the fecal metabolome. The effects of the produced metabolites on mitochondrial activity will moreover be investigated using selected intestinal cell lines.

Enrollment

90 patients

Sex

All

Ages

75+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy
aged 75 years or more

Exclusion criteria

Individuals with chronic bowel diseases
Individuals with severe immunosuppression
Individuals with dementia
Individuals who are terminally ill
If severe/prolonged illness occurs after the start of the test, the subject must drop out of the study
Individuals who have consumed probiotic products after two weeks prior to the start of the study or during it.
Subjects with a history of substance abuse
Subjects that, in the investigators opinion, are not expected to complete the study succesfully