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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Schizophrenia Central Obesity Dietary Supplement: dietary fiber Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients With Central Obesity: a Pilot Study
Estimated Study Start Date : June 20, 2018
Estimated Primary Completion Date : September 20, 2018
Estimated Study Completion Date : December 30, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: dietary fiber intervention group 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Responsible Party: C Lin, Director of General Psychiatry Department, TsaoTun Psychiatric Center, Department of Health, Taiwan
ClinicalTrials.gov Identifier: NCT03552237     History of Changes
Other Study ID Numbers: 106035
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Abdominal
Schizophrenia
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders