Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05527210
Other study ID # HP-00102648
Secondary ID R61AT009990
Status Recruiting
Phase N/A
First received
Last updated
Start date January 25, 2023
Est. completion date January 31, 2026

Study information

Verified date May 2024
Source University of Maryland, Baltimore
Contact Sarah Caimona
Phone 410-402-6883
Email scaimona@som.umaryland.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed project is based on the observation that schizophrenia is characterized by a chronic pro-inflammatory state, which contributes to the severity of a number of the clinical manifestations of the illness, including cognitive impairments, the treatment of which represents a critically important unmet therapeutic need.


Description:

The investigators hypothesize that the level of inflammation in people with schizophrenia can be reduced through the use of the prebiotic: Prebiotin®, an oligofructose-enriched inulin (OEI), to stimulate the activity of butyrate-producing bacteria and increase the production of butyrate, which has multiple anti-inflammatory properties. The investigators will confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance (primary specific aim), symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition. In a sample of participants with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder, the investigators will conduct a 12-week, double-blind, placebo-controlled, randomized clinical trial to confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance, symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 31, 2026
Est. primary completion date January 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. DSM-5 diagnosis of schizophrenia or schizoaffective disorder; 2. Age 18-60 years; 3. Considered clinically stable by the treating psychiatrist; 4. Currently treated with an antipsychotic, with no dose changes in last 14 days; 5. Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent; 6. BMI = 40 Exclusion Criteria: 1. Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol 2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes 3. Intellectual disability 4. Acute antibiotic use 5. Immune therapy within the last three months 6. Prebiotic or probiotic treatment within the last three months 7. Inability to understand English 8. Inability to cooperate with study procedures 9. Pregnant or lactation secondary to pregnancy 10. Participants who meet DSM 5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 3 months will be excluded. Participants who meet DSM 5 criteria for marijuana misuse - mild will be included in the study.

Study Design


Intervention

Dietary Supplement:
Prebiotic
Prebiotin® is a fine, white to slightly yellow powder, which is mixed into water and has a slightly sweet taste.
Placebo Prebiotic
Placebo prebiotic mixed into water

Locations

Country Name City State
United States Maryland Psyciatric Research Center Catonsville Maryland

Sponsors (2)

Lead Sponsor Collaborator
University of Maryland, Baltimore National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in serum butyrate levels Number of participants with an increase in serum butyrate levels at 12 weeks. 12 weeks
Primary Cognition Number of participants with an increase in MCCB composite score at 12 weeks. 12 weeks
Primary Incidence of Side Effects Number of participants with an increased incidence of side effects at 12 weeks. 12 weeks
Secondary Change in Affective Symptoms Number of participants with an increase in affective symptoms at 12 weeks, measured by the Calgary Depression Scale (CDS). 12 weeks
Secondary Change in Positive Symptoms Number of participants with an increase in positive symptoms at 12 weeks, measured by the Brief Psychiatric Rating Scale (BPRS). 12 weeks
Secondary Change in Negative Symptoms Number of participants with an increase in negative symptoms at 12 weeks, measured by the • Scale for the Assessment of Negative Symptoms (SANS). 12 weeks
Secondary Changes in Serum Measurements Number of participants with an increase in fasting levels of serum glucose, triglycerides, and/or cholesterol at 12 weeks. 12 weeks
Secondary Effects of Gut Composition Number of participants with an increase in cytokine, gut permeability, or gut microbiota composition levels at 12 weeks. 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A