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Prebiotic Treatment in People With Schizophrenia

ConditionsSchizophreniaSchizoaffective Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

DSM-5 diagnosis of schizophrenia or schizoaffective disorder;

Age 18-60 years;

Considered clinically stable by the treating psychiatrist;

Currently treated with an antipsychotic, with no dose changes in last 14 days;

Disqualifiers

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

Acute antibiotic use

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prebiotic

    Dietary supplement

    Prebiotin® is a fine, white to slightly yellow powder, which is mixed into water and has a slightly sweet taste.

  • Placebo Prebiotic

    Dietary supplement

    Placebo prebiotic mixed into water

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Active Study MedActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in serum butyrate levels

Number of participants with an increase in serum butyrate levels at 12 weeks.

Time frame
12 weeks
2

Cognition

Number of participants with an increase in MCCB composite score at 12 weeks.

Time frame
12 weeks
3

Incidence of Side Effects

Number of participants with an increased incidence of side effects at 12 weeks.

Time frame
12 weeks

Secondary outcomes

1

Change in Affective Symptoms

Number of participants with an increase in affective symptoms at 12 weeks, measured by the Calgary Depression Scale (CDS).

Time frame
12 weeks
2

Change in Positive Symptoms

Number of participants with an increase in positive symptoms at 12 weeks, measured by the Brief Psychiatric Rating Scale (BPRS).

Time frame
12 weeks
3

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).

Time frame
12 weeks
4

Changes in Serum Measurements

Number of participants with an increase in fasting levels of serum glucose, triglycerides, and/or cholesterol at 12 weeks.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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