Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05850585 |
Other study ID # |
82022023-2 |
Secondary ID |
2021GXLH-Z-083-2 |
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2023 |
Est. completion date |
December 2026 |
Study information
Verified date |
April 2023 |
Source |
First Affiliated Hospital Xi'an Jiaotong University |
Contact |
Feng Zhu, professor |
Phone |
0086-13571827380 |
Email |
zhufeng0714[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study was to explore whether repeated oral fecal capsules could improve
outcomes in patients with schizophrenia receiving conventional antipsychotic drugs. This
study was divided into screening period (1 week) and treatment period (8 weeks). Subjects who
met the inclusion criteria during the screening period entered the treatment period. During
the treatment period, the patients were divided into two groups: oral fecal bacteria capsules
+ antipsychotics group; Oral placebo + antipsychotic group. During the follow-up period, both
groups were treated with stable dose of antipsychotic drugs during the treatment period.
Before and after the intervention, venous blood samples of patients were collected for
routine tests such as liver and kidney function to determine the safety of treatment. The
scale evaluated the improvement of patients' psychotic symptoms to determine the efficacy and
safety of FMT combined with antipsychotics.
Description:
The main research content of this project is to observe the efficacy and safety of adjuvant
FMT capsules in the treatment of schizophrenia by enrolling patients with schizophrenia and
randomly administering FMT combined with antipsychotics or placebo combined with
antipsychotics.
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. In this
study, patients with schizophrenia were randomly divided into two groups. The first group was
the experimental group, and FMT capsules (10^12 CFU/ capsule) were used in addition to
conventional antipsychotic drugs. The other group, a control group, received a placebo pill
with the same color, appearance and smell as the FMT capsules in addition to regular
antipsychotic medication. Placebo capsules contain Lactobacillus probiotics for food use
(10^12 CFU/ capsule). To observe the efficacy and safety of adjuvant FMT capsule in patients
with schizophrenia.
The subjects (inpatients) were evaluated for meeting the eligibility requirements for this
study according to the pre-specified inclusion and exclusion criteria, and demographic data
(age, sex, marital status, educational level, employment, height and weight, smoking and
drinking, and other general information as well as questionnaire assessment of eating habits)
were collected. Improve laboratory examination (blood routine, liver function, kidney
function and lipid), electrocardiogram and scale assessment.
Patients at the end of the screening period were randomly assigned to the experimental and
control groups. Subjects will continue to receive FMT capsules or placebo capsules until the
end of 8 weeks. During this period, both groups were given first-line atypical antipsychotics
(clozapine, olanzapine, quintiapine, risperidone, aripiprazole, Ziprasidone, amsulapride,
paliperidone, and paliperidone palmitate) recommended by current treatment guidelines, and
added to the effective therapeutic dose within 1 week.
Benzodiazepines and drugs that ameliorate side effects of antipsychotics may be used during
the study period. Antidepressants and mood stabilizers are prohibited. Transcranial magnetic
stimulation and electronic biofeedback were allowed during the study, and non-convulsive
electroconvulsive therapy was prohibited.