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

NCT05735418 | Completed

• 1 other identifier: GIB-2022-088
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness

Keywords

gut microbiome; probiotics; muscle strength; intervention

Outcome Measures

Primary Outcomes (1)

• Hand Grip Strength Change

  Change from baseline hand grip strength at 4 weeks

  4 weeks

Secondary Outcomes (2)

• Bacteroidetes/Firmicutes Ratio Change

  4 weeks

• Fasting blood glucose

  4 weeks

Other Outcomes (10)

• Walking speed

  0, 2, 4, 8 weeks

• Gut quotient

  0, 2, 4, 8 weeks

• IGF-1

  0, 2, 4, 8 weeks

Study Arms (2)

GI Biome #7

EXPERIMENTAL

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

Dietary Supplement: GI Biome #7

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

GI Biome #7 DIETARY_SUPPLEMENT

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.

GI Biome #7

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• GI Biome: collaborator

Study Sites (1)

Seoul National University College of Medicine

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Yun-Chul Hong, MD, PhD

  Seoul National University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A double-blind, randomized controlled trial

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 21, 2023
• Study Start: January 13, 2023
• Primary Completion: April 27, 2023
• Study Completion: December 31, 2023
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)