NCT04366401Completed
Efficacy of Prebiotic and Probiotic Dietary Modulation in Schizophrenic Disorders
Efficacy of Dietary Modulation With High Prebiotic and Probiotic Content on Nutritional and Metabolic Status in Schizophrenia Spectrum Disorders
Source: ClinicalTrials.gov · Last updated 9 May 2024
Brief summary (registry, in English)
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 function provides sufficient evidence to establish a causal relationship between numerous neuropsychiatric disorders, such as schizophrenia. Besides, the microbiota modulation through the dietary pattern is related to the improvement of the physical and psychopathological health of patients. In this sense, the use of psychobiotics (prebiotics and probiotics with nutraceutical action) highlights. This research will be aimed to test the efficacy of prebiotic dietary modulation in patients diagnosed with schizophrenia, attending to the impact in nutritional and cardio-metabolic conditions. In this sense, two-arms, double-blind, randomized in balanced blocks clinical trial of six months of intervention, will be developed in a group of 50 individuals (25 for the intervention group (IG) and 25 for the control group). First, an initial group session will be held to present the purpose of the research, as well as each of the relevant aspects during its development. Similarly, certain focus groups will be established periodically to redefine and guide the improvement of the development of the investigation, ensuring adequate compliance with the study after the implementation of the diet and nutrition education program. The dietary education will be designed and supervised by qualified personnel with recognized competencies for this type of intervention (nurses and dietitians). The CG will be made up of those participants who receive conventional dietary advice individually in serial consultations. On the other hand, in the IG, this intervention will be characterized by the establishment of an individual program of dietetic-nutritional education with high prebiotic and probiotic content. During the development of the study, data will be collected on the psychopathological state (PANSS and PSP scales), and blood test (hemogram, lipid profile, etc.). Measures will be taken at the beginning (basal), at three and six months. The estimation of intestinal microbiota and the usual nutritional pattern will also be assessed at the beginning and six months, using a stool test and a validated Food Frequency Questionnaire (FFQ), respectively. To evaluate the degree of adherence, participants in the IG will fill a specific weekly record of the main dishes/food consumed. At least, anthropometric parameters will also be analyzed monthly (BMI, blood pressure, heart rate, abdominal perimeter).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 18 Apr 2020
- Start date
- 25 Jun 2020
- Primary completion date
- 19 Oct 2021
- Lead sponsor
- Universidad de Córdoba
- Diseases
- Schizophrenia
- NCT number
- NCT04366401
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 25 Jun 2020 to the primary completion date, 19 Oct 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- -Concomitant administration of antibiotherapy.
Other
- -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.).
- Refusal to participate in the study.
Who the study is looking for
- -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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de Córdoba. Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.