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

Not Applicable

• Conditions: Schizophrenia; Central Obesity
• Interventions: Dietary Supplement: dietary fiber

• Registration Number: NCT03552237
• Lead Sponsor: TsaoTun Psychiatric Center, Department of Health, Taiwan

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 available

Study Timeline

• Study First Submitted: 2018-05-15
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-08
• Last Update Submitted: 2018-06-08
• Study First Posted: 2018-06-11
• Last Update Posted: 2018-06-11
• Study Start: 2018-06-20
• Primary Completion: 2018-09-20
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dietary fiber intervention group	dietary fiber	-

Primary Outcome Measures

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