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NCT05392348 Clinical Trial

Human Gut Microbiota and microRNA Expression

Gut Microbiota Clinical Trial

Official title:
Regulatory Effect of Stachyose on Gut Microbiota and microRNA Expression in Human

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05392348
Other study ID # KY20212094-C-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 25, 2022
Est. completion date June 30, 2022

Study information
Verified date June 2021
Source Xijing Hospital
Contact Chao Guo
Phone 029-84775475
Email xysn@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, stachyose was used as an intervention factor. We will evaluate changes in fecal gut microbiota and miRNA expression profiles in subjects under stachyose intervention

Description:

In the stachyose intervention group, each person in the stachyose intervention group took 5 g of stachyose daily before breakfast, and the administration method was 100 ml of drinking water dissolved and taken orally for two months. Each person in the placebo control group took the same amount of maltodextrin daily. Stool samples of the subjects were collected weekly.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date June 30, 2022
Est. primary completion date June 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - healthy human Exclusion Criteria: - people who need intake antibiotics,probiotics or its product

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• stachyose
Stachyose is a tetrasaccharide consisting of sucrose having an alpha-D-galactosyl-(1->6)-alpha-D-galactosyl moiety attached at the 6-position of the glucose.
• Maltodextrin
Maltodextrin is a polysaccharide that is used primarily in foods and beverages as a thickener, sweetener, and/or stabilizer. It is a relatively short-chain polymer (some would call it an oligomer); commercial products contain an average of ˜3 to ˜17 glucose units per chain. It is manufactured by partially hydrolyzing grain starches, usually corn or wheat.

Locations
Country Name City State
China the First Affiliate Hospital of the Air Force Medical University Xi'an Shaanxi

Sponsors (1)
Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary expression of microRNA small rna sequencing valuated the microRNA expression in human up to 4 weeks
Primary structure of gut microbiota 16S rDNA sequencing valuated the gut microbiota composition in human up to 4 weeks
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