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

G

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups, including a placebo group

probiotic
Experimental group
Description:
HOWARU Restore
Treatment:
Dietary Supplement: HOWARU Restore
placebo
Placebo Comparator group
Description:
microcrystalline cellulose
Treatment:
Dietary Supplement: HOWARU Restore

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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