NCT04001439

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,088

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

June 20, 2019

Last Update Submit

June 26, 2019

Conditions

Depression in Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • myoglobin concentration

    the primary outcome for efficacy will be the improvement of depressive symtoms

    2 moths

Study Arms (1)

Clinical trial

OTHER

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

Interventions

Experimental drugDRUG

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.

Clinical trial

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • history of lifetime FMT
  • History of gut surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Drugs, Investigational

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All patients will receive 30 microbiota capsules in take proceded by bowel lavage by 4 liters macrogo solution.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2019

First Posted

June 28, 2019

Study Start

December 1, 2019

Primary Completion

February 1, 2020

Study Completion

December 31, 2020

Last Updated

June 28, 2019

Record last verified: 2019-06