ElderlyEarly Phase 1NCT02207140
Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
A Early Phase 1 study testing HOWARU Restore in people with Elderly and Probiotics, run by Gabriella C. van Zanten at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly, Probiotics, Clostridium Difficile
- What is being tested?
- HOWARU Restore
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to May 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy
- aged 75 years or more
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen
Frederiksberg C, 1958
About this study
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.
- Conditions
- Elderly, Probiotics, Clostridium Difficile, Gut Microbiota, Fecal Metabolome
- Being tested
- HOWARU Restore
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOWARU RestoreDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Experimental | HOWARU Restore Receives: Dietary Supplement: HOWARU Restore |
| placebo | Placebo comparator | microcrystalline cellulose Receives: Dietary Supplement: HOWARU Restore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Clostridium difficile numbers
Measured: 24 weeks
Secondary outcomes (1)
fecal microbial composition
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabriella C. van Zanten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriella C. van Zanten, University of Copenhagen
- Investigators
- Gabriella C van Zanten, PhD, Principal investigator, University of Copenhagen, Dept. of Food Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207140
- Sponsor's protocol ID
- DKID H-1-2014-051
- Other IDs
- H-1-2014-051
- Status last verified
- Jun 2016
- First submitted
- 31 Jul 2014
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
- ClinicalTrials.gov ID
- NCT02207140
- Acronym / sponsor ID
- DKID H-1-2014-051
- Conditions
- Elderly, Probiotics, Clostridium Difficile, Gut Microbiota, Fecal Metabolome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gabriella C. van ZantenUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic | Experimental | Dietary Supplement: HOWARU RestoreHOWARU Restore |
| placebo | Placebo comparator | Dietary Supplement: HOWARU Restoremicrocrystalline cellulose |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Healthy
- aged 75 years or more
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOWARU Restore | Dietary supplement | placebo, probiotic |
Primary outcome
Fecal Clostridium difficile numbers
Time frame: 24 weeks
1 secondary outcome
fecal microbial composition
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriella C van Zanten, PhD principal investigator
University of Copenhagen, Dept. of Food Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HOWARU Restore in people with Elderly and Probiotics, run by Gabriella C. van Zanten at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal Clostridium difficile numbers (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.