Synbiotic Compound to Reduce Symptoms of Schizophrenia

Part of paid clinical trials in Batlimore, Maryland.

Sponsor
Sheppard Pratt Health System
Study ID
NCT04226898
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Synbiotic Supplement — BIOLOGICAL
    Synbiotic supplement 1 powder stick by mouth daily
  • Inert Compound — BIOLOGICAL
    Synbiotic supplement identical placebo 1 powder stick by mouth daily

Study Details

The purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.

Key Dates

Start date
Feb 21, 2022
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Synbiotic Supplement
    The active synbiotic supplement consists of a stick/packet containing 4 strains of probiotic microorganisms: Lactobacillus acidophilus, LA-5® (material number 501082 FD LAK KGPharma); Lactobacillis paracasei subsp. paracasei, L. CASEI 431® (material number 684301 FD L. casei 431 HA Granulate); Lactobacillus rhamnosus, LGG® (material number 699817 FD LGG HA-W-IF); and Bifidobacterium animalis subsp. lactis, BB-12® (material number 699813 FD BB-12 HA-W-IF). In addition, the stick/sachet contains 5 g inulin. The product is a powder which participants will be asked to take with liquid or food. In this arm, the participant will take 1 powder stick of the synbiotic supplement once a day for 12 weeks after a 2-week placebo run-in.
  • Placebo Comparator: Inert Compound
    The inert compound placebo looks identical to the synbiotic supplement. In this arm, the participant will take 1 powder stick of the placebo daily for 12 weeks after a 2 week placebo run-in.

Primary Outcome Measure

Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase [ Time Frame: 12 weeks (week 2 to week 14) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sheppard Pratt Health SystemBatlimoreMaryland21285
Emily Katsafanas
[email protected]
443-608-3300

Find similar trials in Batlimore, MD

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Sheppard Pratt Health System· Batlimore, MD

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