FEcal Microbiota Transplantation

NCT ID: NCT04001439

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3088 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-12-31

Brief Summary

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

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.

Conditions

Depression in Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Clinical trial

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.

Group Type: OTHER

Experimental drug

Intervention Type: DRUG

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.

Interventions

Experimental drug

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients aged 18 to 65 years
• with the current diagnosis of shizophrenia

Exclusion Criteria

• history of lifetime FMT
• History of gut surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2019-11

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-11

Identifier Type: -

Identifier Source: org_study_id