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

Early Phase 1CompletedNCT02207140

Gabriella C. van Zanten90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Elderly Probiotics Clostridium Difficile Gut Microbiota Fecal Metabolome

Eligibility

Sex: ALLMin age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Fecal Clostridium difficile numbers

Time frame: 24 weeks

Secondary Outcomes

fecal microbial composition