RECRUITING

Prebiotic Treatment in People With Schizophrenia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prebiotic Treatment in People With Schizophrenia

Quick Facts

Study Start:2023-01-25
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05527210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. DSM-5 diagnosis of schizophrenia or schizoaffective disorder;
  2. 2. Age 18-60 years;
  3. 3. Considered clinically stable by the treating psychiatrist;
  4. 4. Currently treated with an antipsychotic, with no dose changes in last 14 days;
  5. 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. 6. BMI ≤ 40
  1. 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. 2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
  3. 3. Intellectual disability
  4. 4. Acute antibiotic use
  5. 5. Immune therapy within the last three months
  6. 6. Prebiotic or probiotic treatment within the last three months
  7. 7. Inability to understand English
  8. 8. Inability to cooperate with study procedures
  9. 9. Pregnant or lactation secondary to pregnancy
  10. 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.

Contacts and Locations

Study Contact

Sarah Caimona
CONTACT
410-402-6883
scaimona@som.umaryland.edu
Jennifer Zaranski, MA
CONTACT
410-402-6060
jzaranski@som.umaryland.edu

Principal Investigator

Robert Buchanan, M.D.
PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore

Study Locations (Sites)

Maryland Psyciatric Research Center
Catonsville, Maryland, 21228
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Robert Buchanan, M.D., PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-25
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2023-01-25
Study Completion Date2026-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizoaffective Disorder