Prebiotic Treatment in People With Schizophrenia - Pilot Study

NCT03617783 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HP-00081820
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine changes in serum butyrate levels with the prebiotic: Prebiotin (12g/day), an oligofructose-enriched inulin (OEI); the effect of OEI on the composition of the gastrointestinal microbiota in people with schizophrenia; and the relationship of the composition of the gut microbiota to various clinical, cognitive, and neuroimaging variables.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Serum Butyrate Levels

  We will use the following procedure to assess the effect of Prebiotin (OEI) on serum butyrate levels: there will be two test days: a) baseline (Day 0), prior to randomization to OEI or placebo; and b) Day 11, following the 10 day course of OEI/placebo treatment. We will use OEI for the inulin challenge. On the night prior to each test day, participants will receive a digestable and non-fermentable meal, e.g. lasagna. They will then fast from midnight until the morning, when they will receive their standard breakfast and OEI, 12g. We will collect fasting and 6-hour blood samples from each participant. The Day 11 change in serum butyrate levels following the OEI challenge dose (6-hour minus fasting serum butyrate level) will be compared to the Day 0 change in serum butyrate levels to determine whether the 10-day OEI treatment regimen modified the hypothesized biological signature through increased activity of butyrate-producing bacteria. Serum butyrate will be quantified by LC-MS/MS.

  11 days

Study Arms (2)

Prebiotin

ACTIVE COMPARATOR

Drug: Prebiotin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Prebiotin DRUG

Prebiotin (12g/day), an oligofructose-enriched inulin (OEI)

Prebiotin

Placebo DRUG

placebo-OEI

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
• Age 18-60 years
• Clinically stable as determined by opinion of treating clinician
• Currently treated with an antipsychotic, with no dose changes in last 14 days
• Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent.
• BMI ≤ 35

You may not qualify if:

• 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
• Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
• Intellectual disability
• Antibiotic or immune therapy within the last three months
• Prebiotic or probiotic treatment within the last three months
• Inability to understand English
• Inability to cooperate with study procedures
• Pregnant or lactating women secondary to pregnancy
• Meet DSM-5 criteria for alcohol or substance use disorders (except Tobacco Use Disorder) within last 3 months

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)

Catonsville, Maryland, 21228, United States

Location

Related Publications (1)

• Buchanan RW, Werkheiser AE, Michel H, Zaranski J, Glassman M, Adams HA, Vyas G, Blatt F, Pilli NR, Pan Y, Chen S, Fraser CM, Kelly DL, Kane MA. Prebiotic Treatment in People With Schizophrenia. J Clin Psychopharmacol. 2024 Sep-Oct 01;44(5):457-461. doi: 10.1097/JCP.0000000000001899. Epub 2024 Aug 16.

  PMID: 39146178 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Robert Buchanan
• Organization: Maryland Psychiatric Research Center

rwbuchanan@som.umaryland.edu

410-402-7876

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 6, 2018
• Study Start: July 18, 2019
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)