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CompletedNCT03617783preFOCISUpdated Jun 15, 2023Results posted

Prebiotic Treatment in People With Schizophrenia - Pilot Study

A Phase 4 interventional study of Prebiotin and Placebo in Schizophrenia and Schizoaffective Disorder, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

Over the past 10 years, considerable evidence has emerged from animal studies to suggest that the gut microbiome has significant effects on brain development and behavior, with bidirectional communication between the enteric nervous system, gut and the central nervous system (CNS) (Diaz Heijtz et al, 2011; Douglas-Escobar et al, 2013; Dinan et al, 2014). The gut microbiota have been shown to: a) produce multiple neurotransmitters, including gamma-aminobutyric acid (GABA), dopamine, norepinepherine, and serotonin, and may regulate CNS levels of these neurotransmitters; b) modulate brain development through the regulation of synaptogenesis; and c) modulate the levels of stress hormones during brain development, which may affect stress response and anxiety behavior (Diaz Heijtz et al, 2011; Dinan et al, 2014; Sudo et al, 2004; O'Mahony et al, 2015). Moreover, the gut microbiota effects the production of neurotrophins, including brain-derived neurotrophic factor (BDNF), which plays a significant role in neurogenesis and synaptic plasticity (Sudo et al, 2004; Nemani et al, 2015).

The gut microbiome may also affect brain development and function through its regulation of immune system function, which is mediated, in part, through the production of short-chain fatty acids (SCFA). There are three major SCFAs: butyrate, propionate, and acetate. Butyrate is of particular interest, since it plays a key role in maintaining gut homeostasis and epithelial integrity: butyrate is the primary energy source for intestinal colonocytes; and, of the three SCFAs, butyrate appears to have the most pronounced effects on immune system function and may exert its effects directly through immune pathways and indirectly through the maintenance of the integrity of the intestinal-blood barrier (Hamer et al, 2008; Louis et al, 2010; Brahe et al, 2013; Vital et al, 2014). The intestinal-blood barrier restricts the entrance of toxins, pathogens and antigens into the blood circulation; thus, increased permeability could lead to the entrance of substances and subsequent immune response.

The multiple effects of the gut microbiome on brain development and behavior, suggest that alterations in the gut microbiome may occur in schizophrenia and play a part in the pathophysiology of the disorder. The increased prevalence of gastrointestinal disorders in schizophrenia; the association of infections, including infections with Toxoplasma gondii, which can induce intestinal inflammation, with the risk for the development of schizophrenia; and evidence of increased gut permeability provide further indirect evidence for disruption of the gut microbiome in this disorder (Dinan et al, 2014; Nemani et al, 2015; Severance et al, 2012; Severance et al, 2014). Although a number of studies have been conducted in other neuropsychiatric disorders, including autism (Parracho et al, 2005; Tomova et al, 2015), which demonstrate altered bacterial composition of the gut microbiome, there is only one published study of the microbiome in schizophrenia. Yolken and colleagues examined the oropharyngeal microbiome in people with schizophrenia, and found that there were increased levels of the bacteriophage, Lactobacillus phage phiadh, genome in the schizophrenia group, which were correlated with co-occurring immunological disorders (Yolken et al, 2015). There is one published study of gut microbiota in schizophrenia. Shen and colleagues found a significant reduction in butyrate producers in people with schizophrenia compared to healthy controls (Shen et al. Schiz Res, https://doi.org/10.1016/j.schres.2018.01.002).

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.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 26 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
  2. Age 18-60 years
  3. Clinically stable as determined by opinion of treating clinician
  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 ≤ 35

Exclusion criteria

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. Antibiotic or immune therapy within the last three months
  5. Prebiotic or probiotic treatment within the last three months
  6. Inability to understand English
  7. Inability to cooperate with study procedures
  8. Pregnant or lactating women secondary to pregnancy
  9. Meet DSM-5 criteria for alcohol or substance use disorders (except Tobacco Use Disorder) within last 3 months
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    Prebiotin

    Drug: Prebiotin

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugPrebiotin

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

  • DrugPlacebo

    placebo-OEI

06

What researchers measure

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.

    Time frame: 11 days

07

Results

Posted Jun 15, 2023

Participant flow

Participant flow — Overall Study
MilestonePrebiotinPlacebo
Started913
Completed812
Not completed11

Outcome measures

PrimaryChange 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.

Time frame:
11 days
Reported as:
Mean · mg/ml
Change in Serum Butyrate Levels
mg/mlPrebiotinPlacebo
Pre-Treatment Butyrate Level2.42 ± 0.522.34 ± 0.77
Post-Treatment Butyrate Level2.88 ± 1.022.40 ± 0.93

Adverse events

Collected over 10 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Prebiotin0/9 (0%)0/9 (0%)1/9 (11.1%)
Placebo0/13 (0%)0/13 (0%)2/13 (15.4%)
Most frequent other events
Most frequent other events
EventPrebiotinPlacebo
urinary tract infectionRenal and urinary disorders1/90/13
headacheGeneral disorders0/91/13
diarrheaGastrointestinal disorders0/91/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PrebiotinPlaceboTotal
<=18 years000
Between 18 and 65 years91322
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)PrebiotinPlaceboTotal
Female246
Male7916
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PrebiotinPlaceboTotal
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American9817
White044
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)PrebiotinPlaceboTotal
United States91322
Pre-Treatment Baseline Butyrate Level
Pre-Treatment Baseline Butyrate Level(mg/ml)PrebiotinPlaceboTotal
Mean2.42 ± 0.522.34 ± 0.772.37 ± 0.67
08

Study locations

1 site
  • Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
    Catonsville, Maryland 21228, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 13, 2022
  • Informed consent form · Sep 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03617783
Lead sponsor
University of Maryland, Baltimore
Responsible party
Robert Buchanan (Principal Investigator, University of Maryland, Baltimore) — Principal investigator
First posted
Aug 6, 2018
Start date
Jul 18, 2019
Primary completion
Apr 5, 2022
Completion
Apr 5, 2022
Results posted
Jun 15, 2023
Last update
Jun 15, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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