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

Schizophrenia Clinical Trial

Official title:

The Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients With Central Obesity: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03552237
• Other study ID #: 106035
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: June 2018
• Source: TsaoTun Psychiatric Center, Department of Health, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Obesity
• Obesity
• Obesity, Abdominal
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TsaoTun Psychiatric Center, Department of Health, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in microbiota composition at week 4	Fecal samples from participants before and after the intervention will be processed for microbiota analysis	4 weeks