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
About this trial
This is an interventional supportive care trial for Schizophrenia
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
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
NCT ID
NCT03552237
First Posted
May 15, 2018
Last Updated
June 8, 2018
Sponsor
TsaoTun Psychiatric Center, Department of Health, Taiwan
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
Learn more about this trial
Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients
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