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

NCT ID: NCT03552237

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-20
• Study Completion Date: 2018-12-30

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.

Conditions

Schizophrenia; Central Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

dietary fiber intervention group

Group Type: EXPERIMENTAL

dietary fiber

Intervention Type: DIETARY_SUPPLEMENT

We will investigate in a 4 week intervention whether consumption of dietary fiber supplement affect the microbiota composition in schizophrenia patients with central obesity.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TsaoTun Psychiatric Center, Department of Health, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

C Lin

Director of General Psychiatry Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

106035

Identifier Type: -

Identifier Source: org_study_id