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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Muscle Weakness

Intervention / Treatment
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* Dietary Supplement: GI Biome #7
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blind, randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GI Biome #7<br>The intervention consists of daily administration of probiotics GI Biome #7 for four weeks. | Dietary Supplement: GI Biome #7<br>* 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.<br>|
| Placebo Comparator: Placebo<br>The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks. | Dietary Supplement: Placebo<br>* The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand Grip Strength Change | Change from baseline hand grip strength at 4 weeks | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteroidetes/Firmicutes Ratio Change | Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks | 4 weeks | 
| Fasting blood glucose | Change from baseline fasting blood glucose at 4 weeks | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiome, probiotics, muscle strength, intervention