Intestinal C. DifficilePhase 2NCT01475942
Probiotic Intervention With Elderly Subjects
A Phase 2 study testing Probiotic in people with Intestinal C. Difficile, run by Danisco at 1 site in Finland.
Trial summary
The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal C. Difficile
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to Jun 2013
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- elderly subjects
- no acute infection at recruitment
Who cannot join
- antibiotic treatment 1 month prior to beginning of study
- less than 6 month life expectancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo Controlled Study to Assess the Effect of a Probiotic Supplement on the Subclinical Levels of Intestinal C. Difficile Among Elderly
The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.
Read the detailed description
The study objective is to evaluate the effect of a probiotic Lactobacillus strain in lowering the levels of Clostridium difficile in the intestine of elderly subjects. In addition, the nutritional and general health status will be assessed using validated health related questionnaires. Bowel function and prevalence of infections will be followed throughout the intervention period. The study population consists of elderly home inhabitants. The study will be conducted as a double-blind placebo-controlled trial.
- Conditions
- Intestinal C. Difficile
- Being tested
- Probiotic
- Keywords
- elderly, probiotic, bowel function, pathogen, constipation, diarrhoea, Subclinical levels
- Medical subject headings
- Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Lactobacillus
4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Lactobacillus Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Sucrose Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of faecal Clostridium difficile
Quantification of C. difficile from faecal samples
Measured: 0 weeks, 8 weeks, 16 weeks
Secondary outcomes (4)
Change in nutritional status
Evaluated according to the Mini Nutritional Assessment (MNA®) questionnaire.
Measured: 0 weeks, 16 weeks
Change in quality of life
Evaluated according to the validated 15D© health related survey from adequately oriented subjects.
Measured: 0 weeks, 16 weeks
Change in levels of other intestinal pathogens than C. difficile
Quantified from faecal samples
Measured: 0 weeks, 8 weeks, 16 weeks
Change in bowel function
Assessed according to Bristol Stool Form Scale by health care personnel throughout the study
Measured: 0 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal C. DifficileStudies 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
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Turku
- Responsible party
- Sponsor
- Investigators
- Sampo Lahtinen, PhD, Study chair, DaniscoAnna Lyra, PhD, Study director, DaniscoMatti Viitanen, MD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475942
- Sponsor's protocol ID
- Turku_elderly
- Status last verified
- Feb 2015
- First submitted
- 20 Sep 2011
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo Controlled Study to Assess the Effect of a Probiotic Supplement on the Subclinical Levels of Intestinal C. Difficile Among Elderly
- ClinicalTrials.gov ID
- NCT01475942
- Acronym / sponsor ID
- Turku_elderly
- Conditions
- Intestinal C. Difficile
- Keywords
- elderly, probiotic, bowel function, pathogen, constipation, diarrhoea, Subclinical levels
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- University of Turku
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Nov 2011 (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 objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.
Detailed description
The study objective is to evaluate the effect of a probiotic Lactobacillus strain in lowering the levels of Clostridium difficile in the intestine of elderly subjects. In addition, the nutritional and general health status will be assessed using validated health related questionnaires. Bowel function and prevalence of infections will be followed throughout the intervention period. The study population consists of elderly home inhabitants. The study will be conducted as a double-blind placebo-controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticLactobacillus |
| Placebo | Placebo comparator | Dietary Supplement: ProbioticSucrose |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- elderly subjects
- no acute infection at recruitment
Key exclusion criteria (2 listed)
- antibiotic treatment 1 month prior to beginning of study
- less than 6 month life expectancy
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 |
|---|---|---|
| ProbioticAlso: Lactobacillus4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day. | Dietary supplement | Placebo, Probiotic |
Primary outcome
Change in level of faecal Clostridium difficile
Time frame: 0 weeks, 8 weeks, 16 weeks
Quantification of C. difficile from faecal samples
4 secondary outcomes
Change in nutritional status
Time frame: 0 weeks, 16 weeks
Change in quality of life
Time frame: 0 weeks, 16 weeks
Change in levels of other intestinal pathogens than C. difficile
Time frame: 0 weeks, 8 weeks, 16 weeks
Change in bowel function
Time frame: 0 weeks, 16 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 27 Jan 2016.
- Individual participant dataSharing planned: No
Related trials for Intestinal C. Difficile
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingPhase 3
Vancomycin Taper to Prevent Recurrent Clostridioides Difficile
Clostridia Difficile Colitis
RecruitingPhase 2
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
Clostridium Difficile Colitis
Active, not recruitingPhase 4
Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery
Elective Colon Surgery
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.
Sampo Lahtinen, PhD study chair
Danisco
Anna Lyra, PhD study director
Danisco
Matti Viitanen, MD principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Intestinal C. Difficile, run by Danisco at 1 site in Finland.
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 2 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 27 Jan 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 Finland. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in level of faecal Clostridium difficile (time frame: 0 weeks, 8 weeks, 16 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 27 Jan 2016.