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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05735418

Collaborator

GI Biome (Other)

Enrollment

Location

Arms

14.2

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Weakness	Dietary Supplement: GI Biome #7 Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A double-blind, randomized controlled trialA double-blind, randomized controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 24, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: GI Biome #7

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

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.

Placebo Comparator: Placebo

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

Dietary Supplement: Placebo

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

Outcome Measures

Primary Outcome Measures

Hand Grip Strength Change [4 weeks]
Change from baseline hand grip strength at 4 weeks

Secondary Outcome Measures

Bacteroidetes/Firmicutes Ratio Change [4 weeks]
Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks
Fasting blood glucose [4 weeks]
Change from baseline fasting blood glucose at 4 weeks

Other Outcome Measures

Walking speed [0, 2, 4, 8 weeks]
The time to walk a 10-m distance will be measured.
Gut quotient [0, 2, 4, 8 weeks]
Gut quotient measurement scales will be asked using questionnaires. The minimum and maximum values are 0 and 100, respectively. Higher scores are related to worse gut quotient.
IGF-1 [0, 2, 4, 8 weeks]
IGF-1 will be quantified from the participants' serum samples.
Myostatin [0, 2, 4, 8 weeks]
Myostatin will be quantified from the participants' serum samples.
8-OHdG [0, 2, 4, 8 weeks]
8-OHdG will be quantified from the participants' serum samples.
Fecal acetate level [0, 2, 4, 8 weeks]
Acetate level (short-chain fatty acid) will be measured from the participants' stool.
Fecal butyrate level [0, 2, 4, 8 weeks]
Butyrate level (short-chain fatty acid) will be measured from the participants' stool.
Fecal propionate level [0, 2, 4, 8 weeks]
Propionate level (short-chain fatty acid) will be measured from the participants' stool.
Fecal calproate level [0, 2, 4, 8 weeks]
Calproate level (short-chain fatty acid) will be measured from the participants' stool.
Fecal valerate level [0, 2, 4, 8 weeks]
Valerate level (short-chain fatty acid) will be measured from the participants' stool.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University College of Medicine	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital
GI Biome

Investigators

Study Director: Yun-Chul Hong, MD, PhD, Seoul National University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yun-Chul Hong, Professor, Seoul National University

ClinicalTrials.gov Identifier:

NCT05735418

Other Study ID Numbers:

GIB-2022-088

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yun-Chul Hong, Professor, Seoul National University

Additional relevant MeSH terms:

Muscle Weakness

Study Results

No Results Posted as of Feb 21, 2023