Prebiotic Treatment in People With Schizophrenia

Part of paid clinical trials in Catonsville, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05527210
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jan 25, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Active Study Med
    Participants randomized to active study medication will mix 4g of powder prebiotic with water, 3 times a day for 12 weeks.
  • Placebo Comparator: Placebo
    Participants randomized to active study medication will mix 4g of powder placebo with water, 3 times a day for 12 weeks.

Primary Outcome Measure

Change in serum butyrate levels [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Maryland Psyciatric Research CenterCatonsvilleMaryland21228
Matt Glassman
[email protected]
410-402-6411
Jennifer Zaranski, MA
[email protected]
410-402-6060
Robert Buchanan, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Catonsville, MD

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Maryland Psyciatric Research Center· Catonsville, MD

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