Muscle WeaknessNCT05735418
The Effect of GI Biome #7 on Gut Microbiome and Health of the Elderly
A study testing GI Biome #7 in people with Muscle Weakness, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- GI Biome #7
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years old or older
- Those who have no difficulties in daily living
- Willing to commit throughout the study
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University College of Medicine
Seoul, 03080
About this study
Official title: A Study on the Effects of Oral Intake of GI Biome #7 on the Intestinal Microbiome and Health in the Elderly Population
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.
Read the 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.
- Conditions
- Muscle Weakness
- Being tested
- GI Biome #7, Placebo
- Keywords
- gut microbiome, probiotics, muscle strength, intervention
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI Biome #7Dietary 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.
PlaceboDietary supplement
The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| GI Biome #7 | Experimental | The intervention consists of daily administration of probiotics GI Biome #7 for four weeks. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip Strength Change
Change from baseline hand grip strength at 4 weeks
Measured: 4 weeks
Secondary outcomes (2)
Bacteroidetes/Firmicutes Ratio Change
Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks
Measured: 4 weeks
Fasting blood glucose
Change from baseline fasting blood glucose at 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start13 Jan 2023
- Primary completion27 Apr 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GI Biome
- Responsible party
- Principal investigator, Yun-Chul Hong, Seoul National University
- Investigators
- Yun-Chul Hong, MD, PhD, Study director, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735418
- Sponsor's protocol ID
- GIB-2022-088
- Status last verified
- Jun 2024
- First submitted
- 30 Jan 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effects of Oral Intake of GI Biome #7 on the Intestinal Microbiome and Health in the Elderly Population
- ClinicalTrials.gov ID
- NCT05735418
- Acronym / sponsor ID
- GIB-2022-088
- Conditions
- Muscle Weakness
- Keywords
- gut microbiome, probiotics, muscle strength, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- GI Biome
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| GI Biome #7 | Experimental | Dietary Supplement: GI Biome #7The intervention consists of daily administration of probiotics GI Biome #7 for four weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years old or older
- Those who have no difficulties in daily living
- Willing to commit throughout the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI Biome #7It 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. | Dietary supplement | GI Biome #7 |
| PlaceboThe placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks. | Dietary supplement | Placebo |
Primary outcome
Hand Grip Strength Change
Time frame: 4 weeks
Change from baseline hand grip strength at 4 weeks
2 secondary outcomes
Bacteroidetes/Firmicutes Ratio Change
Time frame: 4 weeks
Fasting blood glucose
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Chul Hong, MD, PhD study director
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GI Biome #7 in people with Muscle Weakness, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Grip Strength Change (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.