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

Seoul National University

Status: Completed

Conditions: Muscle Weakness

Treatments: Dietary Supplement: Placebo; Dietary Supplement: GI Biome #7

Study type: Interventional

Funder types: Other

Identifiers

NCT05735418

GIB-2022-088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 60 years old or older
• Those who have no difficulties in daily living
• Willing to commit throughout the study

Exclusion criteria

• Antibiotics medication in the last month.
• Probiotics used in the last months.
• Those who are in the treatment of the following diseases: Liver disease, Neurological disease, Respiratory disease, Tumors, Psychiatric disorders, Angina, Myocardial infarction, and Stroke

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

GI Biome #7

Experimental group

Description:

The intervention consists of daily administration of probiotics GI Biome #7 for four weeks.

Treatment:

Dietary Supplement: GI Biome #7

Placebo

Placebo Comparator group

Description:

The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.

Treatment:

Dietary Supplement: Placebo