Intensive Care UnitsPhase 2HAPY3NCT03350178
Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
A Phase 2 study testing fecal microbiota transfer in people with Intensive Care Units and Fecal Microbiota Transplantation, run by MaaT Pharma at 2 sites in France.
Trial summary
ICU patient's complications are notably due to multiple infections with high risks of sepsis. Those infections would be worsened by any antibiotic resistance mechanism. Thus, reducing MDR portage in health care unit is a global strategy that will benefit for the patients and the health system organization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Units, Fecal Microbiota Transplantation
- What is being tested?
- fecal microbiota transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jan 2018to 19 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Patients hospitalized in ICU
- Patients under mechanical ventilation
- Patients with an expected length of stay of at least 4 days after inclusion
- Patients identified with an MDRB digestive carriage, determined by a positive rectal swab previously performed during ICU stay, according to usual screening
- Expected antibiotic (ATB) duration < 10 days
- Informed written consent from the patient
- In unconscious patients who are not able to give consent for inclusion in the study, relatives (next-of-kin) give assent on every patient's behalf, and patients will be later given the opportunity to withdraw from the study
Who cannot join
- Patients with a high risk of death within 5 days according to investigator's opinion, or subjected to therapeutic limitation decisions
- Antibiotherapy of more than 4 consecutive days at inclusion
- Confirmed or suspected intestinal ischemia
- Confirmed or suspected toxic megacolon or gastrointestinal perforation
- Any gastro-intestinal bleeding in the past 3 months
- Any history of abdominal surgery in the past 3 months
Show all 14Show fewer
- Any history of chronic digestive disease or gastro-intestinal resection
- Any counter indication for Trendelenburg position
- Neutropenia (neutrophil counts < 500 cells/µL)
- Ongoing immunosuppressive therapy (chemotherapy, any immunosuppressive agents, excluding corticosteroids < 0,5 mg/kg/d of equivalent prednisolone)
- Enrollment in another trial that may interfere with this study
- Known allergy or intolerance to trehalose or maltodextrin and latex
- Pregnancy or breastfeeding
- Patients with EBV- serology
Trial locations and contacts
2 sites in 1 country.
About this study
ICU patient's complications are notably due to multiple infections with high risks of sepsis. Those infections would be worsened by any antibiotic resistance mechanism. Thus, reducing MDR portage in health care unit is a global strategy that will benefit for the patients and the health system organization. Fecal Microbiota transfer and restoration is a promising strategy to achieve this purpose.
- Being tested
- fecal microbiota transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transferDrug
transfer of fecal microbiota from healthy donor to the patients
| Study group | Role | What they receive |
|---|---|---|
| treated patients | Experimental | Treated wit FMT Receives: Drug: fecal microbiota transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of FMT-related treatment emergent (serious) adverse events
Occurrence of FMT-related treatment emergent (serious) adverse events
Measured: through study completion, an average of 2 weeks
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
FMT procedure will be considered as good if it has been accepted without any particular reluctance
Measured: through study completion, an average of 2 weeks
Occurrence of FMT-related treatment emergent (serious) adverse events as per investigator's opinion
occurrence of FMT-related treatment emergent (serious) adverse events
Measured: through study completion, an average of 2 weeks
Evaluation of FMT impact on Multi Drug Resistant Bacteria carriage
Based on bacterial culture, description of MDRB carriage. Resistance acquisition or eradication will be evaluated
Measured: through study completion, an average of 2 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 2017
- Study start15 Jan 2018
- Primary completion19 Feb 2019
- Study completion19 Feb 2019
Why it stopped: recruitment shortened
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaaT Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anahita Rouze, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350178
- Sponsor's protocol ID
- MPICU01
- Acronym
- HAPY3
- Status last verified
- Mar 2019
- First submitted
- 14 Nov 2017
- Last updated
- 8 Mar 2019
- Results posted
- 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 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY
- ClinicalTrials.gov ID
- NCT03350178
- Acronym / sponsor ID
- HAPY3 / MPICU01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment shortened
- Enrolment
- 8 participants (actual)
- Lead sponsor
- MaaT PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 22 Nov 2017 (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.
ICU patient's complications are notably due to multiple infections with high risks of sepsis. Those infections would be worsened by any antibiotic resistance mechanism. Thus, reducing MDR portage in health care unit is a global strategy that will benefit for the patients and the health system organization. Fecal Microbiota transfer and restoration is a promising strategy to achieve this purpose.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treated patients | Experimental | Drug: fecal microbiota transferTreated wit FMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18
- Patients hospitalized in ICU
- Patients under mechanical ventilation
- Patients with an expected length of stay of at least 4 days after inclusion
- Patients identified with an MDRB digestive carriage, determined by a positive rectal swab previously performed during ICU stay, according to usual screening
Key exclusion criteria (14 listed)
- Patients with a high risk of death within 5 days according to investigator's opinion, or subjected to therapeutic limitation decisions
- Antibiotherapy of more than 4 consecutive days at inclusion
- Confirmed or suspected intestinal ischemia
- Confirmed or suspected toxic megacolon or gastrointestinal perforation
- Any gastro-intestinal bleeding in the past 3 months
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 |
|---|---|---|
| fecal microbiota transfertransfer of fecal microbiota from healthy donor to the patients | Drug | treated patients |
Primary outcome
Occurrence of FMT-related treatment emergent (serious) adverse events
Time frame: through study completion, an average of 2 weeks
Occurrence of FMT-related treatment emergent (serious) adverse events
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 2 weeks
Occurrence of FMT-related treatment emergent (serious) adverse events as per investigator's opinion
Time frame: through study completion, an average of 2 weeks
Evaluation of FMT impact on Multi Drug Resistant Bacteria carriage
Time frame: through study completion, an average of 2 weeks
Results and safety
The study was stopped early (reason given: recruitment shortened). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- 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.
Anahita Rouze principal investigator
CHRU LILLE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fecal microbiota transfer in people with Intensive Care Units and Fecal Microbiota Transplantation, run by MaaT Pharma at 2 sites 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 8 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: stopped early, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 was stopped early (reason given: recruitment shortened). Results are not available in the source record.
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?
Occurrence of FMT-related treatment emergent (serious) adverse events (time frame: through study completion, an average of 2 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 8 Mar 2019.