NCT05735418

The Effect of GI Biome #7 on Gut Microbiome and Health of the Elderly

A Study on the Effects of Oral Intake of GI Biome #7 on the Intestinal Microbiome and Health in the Elderly Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate the effects of probiotics named GI Biome #7 on the gut microbiome and muscle strength in older adults aged 60 years or older.

Detailed description

This study is a double-blind, randomized controlled trial. A total of 60 healthy adults aged 60 years or older will be recruited, and they will be randomly assigned to the intervention group or the control group. The intervention group will be given GI Biome #7 pills, and the control group will be given the placebo pills for four weeks. The participants will visit the research laboratory four times as follows: A day before starting to take the pills, two weeks later after starting to take the pills, the last day of taking the pills, and four weeks later after the end of taking the pills. Participants' stool, blood, and urine will be sampled every visit, and grip strength and body composition will also be checked.

Conditions

• Muscle Weakness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GI Biome #7	It comprises probiotics (Lactobacillus fermentum, Lactobacillus acidophilus, Lactobacillus plantarum, and Bifidobacterium animalis ssp. lactis) and prebiotics (vitamin B2., Korean red ginseng, and etc.). The administration dosage of probiotics is 5×10\^8 CFU/day.
DIETARY_SUPPLEMENT	Placebo	The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.

Timeline

• Start date: 2023-01-13
• Primary completion: 2023-04-27
• Completion: 2023-12-31
• First posted: 2023-02-21
• Last updated: 2024-06-20

Locations

1 site across 1 country: South Korea