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

Sponsor
TsaoTun Psychiatric Center, Department of Health, Taiwan (Other)
Overall Status
Unknown status
CT.gov ID
NCT03552237
Collaborator
(none)
40
Enrollment
1
Arm
6.3
Anticipated Duration (Months)

Study Details

Study Description

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
  • Dietary Supplement: dietary fiber
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
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
Anticipated Study Start Date :
Jun 20, 2018
Anticipated Primary Completion Date :
Sep 20, 2018
Anticipated Study Completion Date :
Dec 30, 2018

Arms and Interventions

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

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • TsaoTun Psychiatric Center, Department of Health, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
C Lin, Director of General Psychiatry Department, TsaoTun Psychiatric Center, Department of Health, Taiwan
ClinicalTrials.gov Identifier:
NCT03552237
Other Study ID Numbers:
  • 106035
First Posted:
Jun 11, 2018
Last Update Posted:
Jun 11, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obesity
Obesity, Abdominal
Schizophrenia

Study Results

No Results Posted as of Jun 11, 2018