Gut MicrobiotaGIBIOTICSNCT06396728
Use of GI BIOTICS 100B UFC to Improve Intestinal Health in Older Adults
A study testing GI BIOTICS 100B UFC in people with Gut Microbiota and Gut Health, run by Universidad de Almeria at 1 site in Spain.
Trial summary
Type of study: Clinical Trial. Main objective: To study the effect of daily consumption of the probiotic (GI BIOTICS 100B UFC) on intestinal inflammatory markers, intestinal microbiota, intestinal health, body composition and sports performance in older adults for 8 weeks. Read more about this study
- Who is it for?
- Ages 60 to 75 years, men only
- Conditions the study is for
- Gut Microbiota, Gut Health, Digestive System
- What is being tested?
- GI BIOTICS 100B UFC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to Mar 2025
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60-75 years of age men. BMI >25 kg/m2. Be willing to be randomized to either of these 2 groups. Must be sedentary (i.e., do not exercise or go to the gym).
- Must be willing to adhere to all study procedures, including attendance at all study visits.
- Must be willing to have biological samples stored for future research.
- Having self-defined digestive problems (poor digestions, constipation, bloating in response to food, refluxes, heartburn)
Who cannot join
- Diabetes Mellitus
- High Blood Pressure
- Being intolerant to lactose, fructose or sorbitol
- Having consumed probiotics or antibiotics in the last 3 weeks
- Be a regular smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of GI BIOTICS 100B UFC to Improve Intestinal Health and Sports Performance in Older Adults
Type of study: Clinical Trial.
Main objective: To study the effect of daily consumption of the probiotic (GI BIOTICS 100B UFC) on intestinal inflammatory markers, intestinal microbiota, intestinal health, body composition and sports performance in older adults for 8 weeks.
Read more
Participant Population/Health Conditions: The study will involve 44 sedentary men with a body mass index > 25 kg/m2 and aged between 60 and 75 years.
Participants Will:
Be randomised into one of two groups: consumption of a placebo capsule (comparison group) and consumption of GI BIOTICS 100B UFC daily for a period of 8 weeks (experimental group). Provide feces and blood samples before and after the 8-week intervention. Undergo analysis of these samples using advanced techniques to understand the effect of the consumption of the probiotic. Undergo a submaximal stress test and muscle strength will be measured using a handgrip dynamometer.
Read the detailed description
Intestinal health is essential for the general well-being of the body given the great diversity of microorganisms known as intestinal microbiota that the intestine houses. These microorganisms play a crucial role in digestion, nutrient absorption, metabolism and regulation of the immune system. However, various factors such as an unbalanced diet, stress and the use of antibiotics or other medications can alter the balance of the microbiota and lead to intestinal health problems, as occurs in those over 60 years of age. In this context, the use of probiotics has gained recognition as an effective strategy to improve intestinal health. Probiotics involve inoculating the intestine with live microorganisms that, when consumed in adequate amounts, provide health benefits. These beneficial bacteria for our body can colonize the intestine, restore the balance of the microbiota and promote an environment conducive to the proper functioning of the digestive system. Probiotics have shown evidence of improving gut health by strengthening the intestinal barrier, reducing intestinal permeability, and decreasing inflammation. In addition, they can improve the digestion of certain foods, produce beneficial vitamins and metabolites, and compete with harmful bacteria to occupy space in the intestine. Recently, it has been shown that specific bacterial species in the intestine could improve exercise capacity in athletes. In this line of thinking, novel and unpublished data from our laboratory unequivocally demonstrate that specific bacterial species can improve exercise capacity in mice through the gut-muscle axis as the main underlying mechanism. That being said, we hypothesize that daily consumption of the probiotic GI BIOTICS 100B UFC, designed by HSN, will reduce intestinal inflammation by improving gut microbiota composition and gut health. Furthermore, this improvement in the intestinal microbiota will reduce the percentage of body fat, improving the ability to run to exhaustion and force generation in older adults.
- Conditions
- Gut Microbiota, Gut Health, Digestive System, Intestinal Inflammation, Strength
- Being tested
- GI BIOTICS 100B UFC, Placebo Consumption
- Keywords
- Gut, Health, Digestive System, Intestinal Inflammation, Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI BIOTICS 100B UFCDietary supplement
Consumption of GI BIOTICS 100B UFC.
Placebo ConsumptionDietary supplement
Consumption of a placebo capsule.
| Study group | Role | What they receive |
|---|---|---|
| Consumption of GI BIOTICS 100B UFC | Experimental | Participants will consume one GI BIOTICS 100B UFC capsule daily for a period of 8 weeks; n=22. Receives: Dietary Supplement: GI BIOTICS 100B UFC |
| Placebo Consumption | Placebo comparator | Participants will consume one placebo capsule daily for a period of 8 weeks; n=22. Receives: Dietary Supplement: Placebo Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal permeability
LPS and Zonulin will be quantified in feces before and after the intervention
Measured: 1 year
Gut microbiota
In feces samples, 16S ribosomal RNA sequencing will be performed to quantify the composition of the intestinal microbiota.
Measured: 1 year
Secondary outcomes (4)
Body composition
The body composition of the participants will be measured using a state-of-the-art device.
Measured: 1 year
Blood samples
These samples will be centrifuged, and the serum and plasma will be aliquoted and stored at -80ºC for future analyses.
Measured: 1 year
Submaximal physical effort test
Sports performance will be evaluated through a submaximal physical effort test.
Measured: 1 year
Muscle strength
Muscle strength will be measured using a handgrip dynamometer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study involves a total of 44 men who will be randomly selected to be part of two groups: one who will consume a placebo capsule and another who will consume GI BIOTICS 100B UFC daily for a period of 8 weeks.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borja Martínez Tellez, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396728
- Sponsor's protocol ID
- TRFE-SI-2023/006
- Acronym
- GIBIOTICS
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of GI BIOTICS 100B UFC to Improve Intestinal Health and Sports Performance in Older Adults
- ClinicalTrials.gov ID
- NCT06396728
- Acronym / sponsor ID
- GIBIOTICS / TRFE-SI-2023/006
- Conditions
- Gut Microbiota, Gut Health, Digestive System, Intestinal Inflammation, Strength
- Keywords
- Gut, Health, Digestive System, Intestinal Inflammation, Strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 2 May 2024 (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.
Type of study: Clinical Trial.
Main objective: To study the effect of daily consumption of the probiotic (GI BIOTICS 100B UFC) on intestinal inflammatory markers, intestinal microbiota, intestinal health, body composition and sports performance in older adults for 8 weeks.
Participant Population/Health Conditions: The study will involve 44 sedentary men with a body mass index > 25 kg/m2 and aged between 60 and 75 years.
Participants Will:
Be randomised into one of two groups: consumption of a placebo capsule (comparison group) and consumption of GI BIOTICS 100B UFC daily for a period of 8 weeks (experimental group). Provide feces and blood samples before and after the 8-week intervention. Undergo analysis of these samples using advanced techniques to understand the effect of the consumption of the probiotic. Undergo a submaximal stress test and muscle strength will be measured using a handgrip dynamometer.
Detailed description
Intestinal health is essential for the general well-being of the body given the great diversity of microorganisms known as intestinal microbiota that the intestine houses. These microorganisms play a crucial role in digestion, nutrient absorption, metabolism and regulation of the immune system. However, various factors such as an unbalanced diet, stress and the use of antibiotics or other medications can alter the balance of the microbiota and lead to intestinal health problems, as occurs in those over 60 years of age. In this context, the use of probiotics has gained recognition as an effective strategy to improve intestinal health. Probiotics involve inoculating the intestine with live microorganisms that, when consumed in adequate amounts, provide health benefits. These beneficial bacteria for our body can colonize the intestine, restore the balance of the microbiota and promote an environment conducive to the proper functioning of the digestive system. Probiotics have shown evidence of improving gut health by strengthening the intestinal barrier, reducing intestinal permeability, and decreasing inflammation. In addition, they can improve the digestion of certain foods, produce beneficial vitamins and metabolites, and compete with harmful bacteria to occupy space in the intestine. Recently, it has been shown that specific bacterial species in the intestine could improve exercise capacity in athletes. In this line of thinking, novel and unpublished data from our laboratory unequivocally demonstrate that specific bacterial species can improve exercise capacity in mice through the gut-muscle axis as the main underlying mechanism. That being said, we hypothesize that daily consumption of the probiotic GI BIOTICS 100B UFC, designed by HSN, will reduce intestinal inflammation by improving gut microbiota composition and gut health. Furthermore, this improvement in the intestinal microbiota will reduce the percentage of body fat, improving the ability to run to exhaustion and force generation in older adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study involves a total of 44 men who will be randomly selected to be part of two groups: one who will consume a placebo capsule and another who will consume GI BIOTICS 100B UFC daily for a period of 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Consumption of GI BIOTICS 100B UFC | Experimental | Dietary Supplement: GI BIOTICS 100B UFCParticipants will consume one GI BIOTICS 100B UFC capsule daily for a period of 8 weeks; n=22. |
| Placebo Consumption | Placebo comparator | Dietary Supplement: Placebo ConsumptionParticipants will consume one placebo capsule daily for a period of 8 weeks; n=22. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60-75 years of age men. BMI >25 kg/m2. Be willing to be randomized to either of these 2 groups. Must be sedentary (i.e., do not exercise or go to the gym).
- Must be willing to adhere to all study procedures, including attendance at all study visits.
- Must be willing to have biological samples stored for future research.
- Having self-defined digestive problems (poor digestions, constipation, bloating in response to food, refluxes, heartburn)
Key exclusion criteria (5 listed)
- Diabetes Mellitus
- High Blood Pressure
- Being intolerant to lactose, fructose or sorbitol
- Having consumed probiotics or antibiotics in the last 3 weeks
- Be a regular smoker
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 BIOTICS 100B UFCConsumption of GI BIOTICS 100B UFC. | Dietary supplement | Consumption of GI BIOTICS 100B UFC |
| Placebo ConsumptionConsumption of a placebo capsule. | Dietary supplement | Placebo Consumption |
Primary outcome
Intestinal permeability
Time frame: 1 year
LPS and Zonulin will be quantified in feces before and after the intervention
Gut microbiota
Time frame: 1 year
In feces samples, 16S ribosomal RNA sequencing will be performed to quantify the composition of the intestinal microbiota.
4 secondary outcomes
Body composition
Time frame: 1 year
Blood samples
Time frame: 1 year
Submaximal physical effort test
Time frame: 1 year
Muscle strength
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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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.
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 BIOTICS 100B UFC in people with Gut Microbiota and Gut Health, run by Universidad de Almeria at 1 site in Spain.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 May 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Borja Martinez Tellez, PhD (+34 950215334 ext. +34, borjammt@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal permeability (time frame: 1 year). The study lists 2 primary outcomes in all. 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 2 May 2024.