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

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ClinicalTrials.gov Identifier: NCT03552237
Recruitment Status : Not yet recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
C Lin, TsaoTun Psychiatric Center, Department of Health, Taiwan

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE June 11, 2018
Last Update Posted Date June 11, 2018
Estimated Study Start Date  ICMJE June 20, 2018
Estimated Primary Completion Date September 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
Changes from baseline in microbiota composition at week 4 [ Time Frame: 4 weeks ]
Fecal samples from participants before and after the intervention will be processed for microbiota analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients
Official Title  ICMJE The Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients With Central Obesity: a Pilot Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Schizophrenia
  • Central Obesity
Intervention  ICMJE Dietary Supplement: dietary fiber
We will investigate in a 4 week intervention whether consumption of dietary fiber supplement affect the microbiota composition in schizophrenia patients with central obesity.
Study Arms  ICMJE Experimental: dietary fiber intervention group
Intervention: Dietary Supplement: dietary fiber
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2018
Estimated Primary Completion Date September 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03552237
Other Study ID Numbers  ICMJE 106035
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party C Lin, TsaoTun Psychiatric Center, Department of Health, Taiwan
Study Sponsor  ICMJE TsaoTun Psychiatric Center, Department of Health, Taiwan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TsaoTun Psychiatric Center, Department of Health, Taiwan
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP