Status:
COMPLETED
Efficacy of Prebiotic and Probiotic Dietary Modulation in Schizophrenic Disorders
Lead Sponsor:
Universidad de Córdoba
Collaborating Sponsors:
Castilla-León Health Service
Conditions:
Schizophrenia and Related Disorders
Diet Habit
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The microbiota plays a vital role in the two-way communication between the gastrointestinal tract and the central nervous system (CNS), articulated as the microbiota-intestine-brain axis. This functio...
Detailed Description
1. INTRODUCTION 1.1. Theoretical Framework Schizophrenia is a chronic mental illness characterized by significant clinical heterogeneity and a long evolution over time, determined by periods o...
Eligibility Criteria
Inclusion
- -Patients diagnosed on the spectrum of schizophrenia (without distinction by type), according to criteria DSM-5 and/or ICD-11.
- Age between 18-65 years.
- \- Absence of gastrointestinal comorbidity that contraindicates the use of prebiotics and/or probiotics (intolerance, explosive diarrhea, acute abdominal pain, etc.).
- -To show clinical stability for six months before the start of the study (absence of psychiatric hospitalization, maintenance of the level of functionality, and lack of social and occupational absenteeism).
- \- To manifest agreement to participate in the study and to sign of informed consent.
Exclusion
- -Non-compliance with the inclusion criteria mentioned above.
- \- To suffer from somatic or neurocognitive situation that prevents participation and collaboration in the fulfillment of the protocol.
- \- To follow standardized dietary planning not modulated by the population under study (catering, institutional or collective feeding, etc.).
- -Concomitant administration of antibiotherapy.
- Refusal to participate in the study.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04366401
Start Date
June 25 2020
End Date
December 26 2023
Last Update
May 9 2024
Active Locations (1)
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1
Universidad de Córdoba.
Córdoba, Spain, 14071