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

Primary Purpose

Muscle Weakness

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GI Biome #7

Placebo

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring gut microbiome, probiotics, muscle strength, intervention

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Seoul National University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GI Biome #7

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hand Grip Strength Change

Change from baseline hand grip strength at 4 weeks

Secondary Outcome Measures

Bacteroidetes/Firmicutes Ratio Change

Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks

Fasting blood glucose

Change from baseline fasting blood glucose at 4 weeks

Full Information

NCT ID

NCT05735418

First Posted

January 30, 2023

Last Updated

February 9, 2023

Sponsor

Seoul National University Hospital

Collaborators

GI Biome

1. Study Identification

Unique Protocol Identification Number

NCT05735418

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 24, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

GI Biome

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Weakness

Keywords

gut microbiome, probiotics, muscle strength, intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A double-blind, randomized controlled trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GI Biome #7

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

GI Biome #7

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Hand Grip Strength Change

Description

Change from baseline hand grip strength at 4 weeks

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Bacteroidetes/Firmicutes Ratio Change

Description

Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks

Time Frame

4 weeks

Title

Fasting blood glucose

Description

Change from baseline fasting blood glucose at 4 weeks

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

Walking speed

Description

The time to walk a 10-m distance will be measured.

Time Frame

0, 2, 4, 8 weeks

Title

Gut quotient

Description

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.

Time Frame

0, 2, 4, 8 weeks

Title

IGF-1

Description

IGF-1 will be quantified from the participants' serum samples.

Time Frame

0, 2, 4, 8 weeks

Title

Myostatin

Description

Myostatin will be quantified from the participants' serum samples.

Time Frame

0, 2, 4, 8 weeks

Title

8-OHdG

Description

8-OHdG will be quantified from the participants' serum samples.

Time Frame

0, 2, 4, 8 weeks

Title

Fecal acetate level

Description

Acetate level (short-chain fatty acid) will be measured from the participants' stool.

Time Frame

0, 2, 4, 8 weeks

Title

Fecal butyrate level

Description

Butyrate level (short-chain fatty acid) will be measured from the participants' stool.

Time Frame

0, 2, 4, 8 weeks

Title

Fecal propionate level

Description

Propionate level (short-chain fatty acid) will be measured from the participants' stool.

Time Frame

0, 2, 4, 8 weeks

Title

Fecal calproate level

Description

Calproate level (short-chain fatty acid) will be measured from the participants' stool.

Time Frame

0, 2, 4, 8 weeks

Title

Fecal valerate level

Description

Valerate level (short-chain fatty acid) will be measured from the participants' stool.

Time Frame

0, 2, 4, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ji Eun Lee, MSc

Phone

822-740-8572

leje93@snu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yun-Chul Hong, MD, PhD

Organizational Affiliation

Seoul National University

Official's Role

Study Director

Facility Information:

Facility Name

Seoul National University College of Medicine

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ji Eun Lee, MSc

Phone

822-740-8572

leje93@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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