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Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients

Primary Purpose

Schizophrenia, Central Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dietary fiber
Sponsored by
TsaoTun Psychiatric Center, Department of Health, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Schizophrenia inpatients
  2. Overweight and with central obesity
  3. agree to sign informed consent

Exclusion Criteria:

  1. Diagnosis of IBS
  2. Systemic antibiotic use during the past 4 weeks
  3. Excessive water intake

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    dietary fiber intervention group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes from baseline in microbiota composition at week 4
    Fecal samples from participants before and after the intervention will be processed for microbiota analysis

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2018
    Last Updated
    June 8, 2018
    Sponsor
    TsaoTun Psychiatric Center, Department of Health, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03552237
    Brief Title
    Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients
    Official Title
    The Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients With Central Obesity: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 20, 2018 (Anticipated)
    Primary Completion Date
    September 20, 2018 (Anticipated)
    Study Completion Date
    December 30, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TsaoTun Psychiatric Center, Department of Health, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Background There has been much interest in the relationship between the types of gut microbiota and the development of obesity in recent years. It has been reported that the proportions of Firmicutes and Bacteroidetes differ between obese and normal weight human subjects. Human intestinal microbiota compositions have been found to be associated with long-term dietary habits and lifestyle. However, an increasing number of researches show that intestinal microbiota composition may be affected after short-term diet intervention. Importantly, obesity and metabolic problems play important roles in morbidity and mortality of schizophrenia patients. Human intestinal microbiota compositions related with obesity may impact the heath of this population. Therefore, we searched current advances about the connection of obesity, intestinal microbiota compositions, and diet in schizophrenia to conduct a clinical research focus on the effect of high fiber diet on the intestinal microbiota of schizophrenia patients with central obesity. Method We will investigate in a 4-week intervention whether consumption of dietary fiber supplement(Inulin) affect the microbiota composition in schizophrenia inpatients with central obesity. Fecal samples from participants before and after the intervention will be processed for the microbiota analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Central Obesity

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dietary fiber intervention group
    Arm Type
    Experimental
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    dietary fiber
    Intervention Description
    We will investigate in a 4 week intervention whether consumption of dietary fiber supplement affect the microbiota composition in schizophrenia patients with central obesity.
    Primary Outcome Measure Information:
    Title
    Changes from baseline in microbiota composition at week 4
    Description
    Fecal samples from participants before and after the intervention will be processed for microbiota analysis
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Schizophrenia inpatients Overweight and with central obesity agree to sign informed consent Exclusion Criteria: Diagnosis of IBS Systemic antibiotic use during the past 4 weeks Excessive water intake

    12. IPD Sharing Statement

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    Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients

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