FEcal Microbiota Transplantation

Study Overview
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Brief Summary
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The primary objective will be to evaluate effectiveness, safety and acceptability of FMT on depressive symptoms at 2 months follow-up in SZ patients with resistant MD.

Detailed Description
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Background. Major Depression (MD) will move into the first place of cause of the global burden of disease by 2030. Conventional treatments (antidepressants) are only partly effective with frequent side effects. More specifically, MD is underdiagnosed and undertreated in schizophrenia (SZ) despite its high impact on prognosis and quality of life in SZ patients. Even when treated, 44% of the patients remain major depressed under conventional antidepressants. FEMADSZ makes the hypothesis that this is due to the fact that the source of MD relies outside the brain, in the gut microbiota. The associations between microbiota disturbances are now well demonstrated in rodent models (>60 studies) and indirect data in humans clearly suggest that the microbiota hypothesis of MD is the most promising track in psychiatry. The primary objective will be to evaluate effectiveness, safety and acceptability of FMT on depressive symptoms at 2 months follow-up in SZ patients with resistant MD. Methods: This is a pilot, single-arm, prospective, open-label proof-of-concept trial, including SZ patients with resistant MD. Fifteen patients will be enrolled and administered a Fecal Microbiota Transplantation. The main outcome measure will be depressive score at 2 months, adverse events and acceptability. Each patient will receive a FDG-PET scan, a routine blood draw and a metagenomic microbiota analysis before and after intervention. Expected results. This pilot study will help determining the effectiveness of FMT and the neurobiologic and microbiologic mechanisms associated with response to treatment.

Official Title
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FEcal Microbiota Transplantation for MAjor Depression in Schizophrenia (FEMADSZ)

Conditions
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Depression in Schizophrenia

Intervention / Treatment
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* Drug: Experimental drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 18 to 65 years with the current diagnosis of shizophrenia Exclusion Criteria: history of lifetime FMT History of gut surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All patients will receive 30 microbiota capsules in take proceded by bowel lavage by 4 liters macrogo solution.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinical trial<br>the study design is an open-label, single-arm propective clinical trial. In this proof-of-concept study we will assess feasibility safety and potential efficacy of an intervention of FMT in SZ subjects with MD. | Drug: Experimental drug<br>* All patients will recive 30 microbiota capsules intake preceded by bowel lavage by 4 liters macrogol solution. the capsules are developed by the services of JC Lagier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myoglobin concentration | the primary outcome for efficacy will be the improvement of depressive symtoms | 2 moths |