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

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207140
• Other study ID #: DKID H-1-2014-051
• Secondary ID: H-1-2014-051
• Status: Completed
• Phase: Phase 0
• First received: July 31, 2014
• Last updated: June 20, 2016
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Clostridium Difficile
• Elderly
• Fecal Metabolome
• Gut Microbiota
• Probiotics

Intervention

Dietary Supplement:
• HOWARU Restore

Locations

Country	Name	City	State
Denmark	Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen	Frederiksberg C

Sponsors (1)

Lead Sponsor	Collaborator
Gabriella C. van Zanten

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fecal metabolome		24 weeks	No
Primary	Fecal Clostridium difficile numbers		24 weeks	No
Secondary	fecal microbial composition		24 weeks	No