Fecal Microbiota TransplantationPROFITNCT04078581
Profiling Fecal Samples for Selection of Donors of Feces
A study testing Questionnaire and fecal sample collection in people with Fecal Microbiota Transplantation, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fecal Microbiota Transplantation
- What is being tested?
- Questionnaire and fecal sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Jun 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Healthy volunteers
- Participant having been informed of the study and having sign a consent to participation
- Patient affiliated with a social security or beneficiary of such a social protection
Who cannot join
- Person subject to legal protection (guardianship, trusteeship, etc.)
- Chronic disease that can alter the intestinal microbiota: cancer or malignant disease, bowel disease, diabetes, hypertension, hypercholesterolemia, ....
- Presence in the 1st degree family of one of the chronic diseases mentioned above
- Blood in stools
- Chronic drug treatment likely to alter the intestinal microbiota
- Travel to a tropical country in the last 3 months or extended stay (> 3 months) for less than 1 year
Show all 14Show fewer
- Hospitalization abroad (> 24h) in the last 12 months
- Hospitalization abroad (> 24h) of a family member living under the same roof during the last 12 months
- Medical consultation in the last 3 months (other than administrative)
- Contact with a person with an infectious or contagious disease for more than 3 months
- Digestive disorders / febrile gastroenteritis (diarrhea with fever) in the last 3 months
- Febrile illnesses for more than 3 months
- Antibiotic treatment in the last 3 months
- Treatment with PPIs in the last 3 months
About this study
Official title: Profiling Fecal Samples to Optimize Selection of Stool Donors for Fecal Microbiota Transplantation
Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis …. A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure.
Read the detailed description
Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis …. A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure. The aim of our study is to measure fecal biochemical, microbial and immunological parameters that are known to influence gut homeostasis in a group of 40 healthy donors to establish a referential profile of human stools to optimize donor profiling, beyond the infectious parameters, to increase the success rate of FMT.
- Conditions
- Fecal Microbiota Transplantation
- Being tested
- Questionnaire and fecal sample collection
- Keywords
- Selection of healthy donors, Healthy volunteers, Stool donors, Fecal microbiota transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and fecal sample collectionOther
Questionnaire and fecal sample collection in order to select donors for FMT.
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Experimental | Questionnaire and fecal sample collection Receives: Other: Questionnaire and fecal sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of fecal samples with search for differentiated fecal profiles.
16S genomic analysis of microbiota will be performed for the evaluation of alpha and beta diversities of microbiota.
Results will be aggregated to define differentiated faecal profiles in healthy volunteers.
Measured: At 12 months
Secondary outcomes (2)
Dosage of fecal biomarkers with search for differentiated fecal profiles.
Fecal biomarkers such as calprotectin will be dosed. Results will be aggregated to define differentiated faecal profiles in healthy volunteers.
Measured: At 12 months
Quantification of colonic inflammation in mouse model.
The quantification of colonic inflammation by myeloperoxidase assay using a sandwich ELISA enzyme-linked immunosorbent assay.
Mouse model : authorization APAFlS#7600-20l60620l6336853 v3
Measured: At 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startMar 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Microbiota TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, University of Paris 5 - Rene Descartes
- Responsible party
- Sponsor
- Investigators
- Nathalie KAPEL, PharmD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078581
- Sponsor's protocol ID
- APHP190341
- Other IDs
- 2019-A01012-55
- Acronym
- PROFIT
- Status last verified
- Mar 2020
- First submitted
- 26 Apr 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling Fecal Samples to Optimize Selection of Stool Donors for Fecal Microbiota Transplantation
- ClinicalTrials.gov ID
- NCT04078581
- Acronym / sponsor ID
- PROFIT / APHP190341
- Conditions
- Fecal Microbiota Transplantation
- Keywords
- Selection of healthy donors, Healthy volunteers, Stool donors, Fecal microbiota transplantation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, University of Paris 5 - Rene Descartes
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 6 Sep 2019 (actual)
- 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.
Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis …. A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure.
Detailed description
Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis …. A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure. The aim of our study is to measure fecal biochemical, microbial and immunological parameters that are known to influence gut homeostasis in a group of 40 healthy donors to establish a referential profile of human stools to optimize donor profiling, beyond the infectious parameters, to increase the success rate of FMT.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy controls | Experimental | Other: Questionnaire and fecal sample collectionQuestionnaire and fecal sample collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Healthy volunteers
- Participant having been informed of the study and having sign a consent to participation
- Patient affiliated with a social security or beneficiary of such a social protection
Key exclusion criteria (14 listed)
- Person subject to legal protection (guardianship, trusteeship, etc.)
- Chronic disease that can alter the intestinal microbiota: cancer or malignant disease, bowel disease, diabetes, hypertension, hypercholesterolemia, ....
- Presence in the 1st degree family of one of the chronic diseases mentioned above
- Blood in stools
- Chronic drug treatment likely to alter the intestinal microbiota
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 |
|---|---|---|
| Questionnaire and fecal sample collectionQuestionnaire and fecal sample collection in order to select donors for FMT. | Other | healthy controls |
Primary outcome
Dosage of fecal samples with search for differentiated fecal profiles.
Time frame: At 12 months
16S genomic analysis of microbiota will be performed for the evaluation of alpha and beta diversities of microbiota. Results will be aggregated to define differentiated faecal profiles in healthy volunteers.
2 secondary outcomes
Dosage of fecal biomarkers with search for differentiated fecal profiles.
Time frame: At 12 months
Quantification of colonic inflammation in mouse model.
Time frame: At 15 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Nathalie KAPEL, PharmD, PhD study director
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and fecal sample collection in people with Fecal Microbiota Transplantation, run by Assistance Publique - Hôpitaux de Paris.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Dosage of fecal samples with search for differentiated fecal profiles. (time frame: At 12 months). 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 3 Jul 2023.