Lactobacillus PlantarumNCT02884336
Lactobacillus Plantarum: Thumb Osteoarthritis Following Orange Peeling
An observational study of Lactobacillus Plantarum, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Lactobacillus Plantarum
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to May 2015
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: A patient who had osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel.
Who may be able to join
- Clinical diagnosis of an osteoarthritis,
- Amputation of the distal phalanx of the right thumb
Who cannot join
- Not exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.
Read the detailed description
Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.
- Conditions
- Lactobacillus Plantarum
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Lactobacillus plantarum
This study was conducted like a case report to describe osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactobacillus PlantarumStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mizrahi Assaf, Assaf, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884336
- Sponsor's protocol ID
- Lactobacillus plantarum
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Plantarum: Thumb Osteoarthritis Following Orange Peeling
- ClinicalTrials.gov ID
- NCT02884336
- Acronym / sponsor ID
- Lactobacillus plantarum
- Conditions
- Lactobacillus Plantarum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 31 Aug 2016 (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.
Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.
Detailed description
Case Description osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A patient who had osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel.
Key inclusion criteria (2 listed)
- Clinical diagnosis of an osteoarthritis,
- Amputation of the distal phalanx of the right thumb
Key exclusion criteria (1 listed)
- Not exclusion criteria
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 |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Identification of Lactobacillus plantarum
Time frame: Day 1
This study was conducted like a case report to describe osteoarthritis + amputation of the distal phalanx of the right thumb caused by Lactobacillus plantarum after an orange peel. The natural habitat of the bacteria being the orange zest and the bacteria is considered harmless
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 31 Aug 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.
Mizrahi Assaf, Assaf principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactobacillus Plantarum, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 1 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 31 Aug 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Identification of Lactobacillus plantarum (time frame: Day 1). 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 31 Aug 2016.