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

• Sponsor: Gabriella C. van Zanten (Other)
• Overall Status: Completed
• CT.gov ID: NCT02207140
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Elderly; Probiotics; Clostridium Difficile; Gut Microbiota; Fecal Metabolome	Dietary Supplement: HOWARU Restore	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: probiotic HOWARU Restore	Dietary Supplement: HOWARU Restore
Placebo Comparator: placebo microcrystalline cellulose	Dietary Supplement: HOWARU Restore

Outcome Measures

Primary Outcome Measures

1. Fecal Clostridium difficile numbers [24 weeks]

Secondary Outcome Measures

1. fecal microbial composition [24 weeks]

Other Outcome Measures

1. fecal metabolome [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 75 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen	Frederiksberg C		Denmark	1958

Sponsors and Collaborators

• Gabriella C. van Zanten

Investigators

• Principal Investigator: Gabriella C van Zanten, PhD, University of Copenhagen, Dept. of Food Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gabriella C. van Zanten, Postdoc, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT02207140
• Other Study ID Numbers: DKID H-1-2014-051; H-1-2014-051
• First Posted: Aug 4, 2014
• Last Update Posted: Jun 21, 2016
• Last Verified: Jun 1, 2016

Study Results

No Results Posted as of Jun 21, 2016