Elite CyclistsEXOMICNCT05220657
Exploring the Relationship Between the Gut Microbiome, Physical Fitness Levels and Metabolic Responses to Exercise
An observational study of Elite Cyclists and Elite Soccer Players, run by University of Rennes 2 at 1 site in France.
Trial summary
Gut microbiota are all microorganisms including bacteria and microscopic eukaryotes that live in the digestive tracts of humans or mammals. During the last decade, some authors highlighted that a link exists between gut microbiota and sport performance. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Elite Cyclists, Elite Soccer Players, Sedentary Behavior
- What is being tested?
- Maximal incremental exercise test and Submaximal exercise test
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2022to 23 Nov 2022
- Phase
- Observational
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Populations located in a continuum from inactive people to top-level athletes with high (i.e. soccer players) and very high energy needs (i.e. cyclists).
Who may be able to join
- BMI between 18 and 25 kg/m²
- Non-smoker
- Written informed consent
Who cannot join
- Cardiovascular risks
- Metabolic diseases (e.g. diabetes)
- Use of antibiotics, anti-fungi or anti-parasites in the last 3 months or during participation in the study
- Use of prebiotics and / or probiotics in the form of supplements in the 7 days preceding the start of the study (greater than or equal to 100000000 Colony Forming Units or organisms per day)
- Taking drug treatment for chronic pain management (paracetamol, vasodilator, homeopathy, aspirin greater than 500 mg per day)
- Simultaneous participation in another research involving the human person or having recently participated in another research for which the exclusion period has not been completed.
Trial locations and contacts
1 site in 1 country.
France1 site
University Rennes 2 - Laboratory "Movement, Sport and health Sciences"
Bruz, Brittany Region, 35170
About this study
Official title: Exploring the Relationship Between the Gut Microbiome Based Metagenomic Signature, Physical Fitness Levels and Metabolic Responses to Exercise: a Pilot Study on 50 Healthy Male Volunteers
Gut microbiota are all microorganisms including bacteria and microscopic eukaryotes that live in the digestive tracts of humans or mammals. During the last decade, some authors highlighted that a link exists between gut microbiota and sport performance. In this project, we hypothesize that gut microbiota is able to adapt to the energy needs of the body, really higher in top-level athletes or considerably lower in inactive individuals. In this context, this clinical study aims to characterize the bacterial metagenome of gut microbiota from populations located in a continuum from sedentary people to top-level athletes with high (i.e. soccer players), even very high energy needs (i.e. cyclists). The finality of this project is thus to determine if it exists some bacterial profile allowing to characterize, even to predict, the energy metabolism of an athlete and so the probability to be performant in competition.
Read the detailed description
Gut microbiota are all microorganisms including bacteria, archaea and microscopic eukaryotes that live in the digestive tracts of humans or mammals. All these microorganisms live in homeostasis in the gastrointestinal tract and provide a variety of benefits to the host immune system and energy metabolism in a state called eubiosis. On contrary, a state of dysbiosis occurs when the diversity of commensal bacteria is reduced especially in some chronic diseases including obesity, cancer or gastrointestinal diseases. During the last decade, substantial studies highlighted that a link exists between gut microbiota composition and sport performance. Research team especially identified a direct link between gut microbiota and skeletal muscle, a key organ in sport performance (Nay et al. 2019). Using rodent models, They observed that 1) the endurance performance was reduced in mice for which the gut microbiome had been experimentally destructed (Nay et al. 2019), and 2) the reduction of endurance performance was due to lower muscle glycogen levels, a key energy substrate for muscle endurance.
Complementary researches have been conducted in humans to characterize the impact of physical activity on gut microbiota composition and function. A study conducted in large American cohort of 1500 individuals have thus highlighted that the gut microbiota diversity was much more important in individuals performing regular physical activity (3-5 times/week or more) compared to physically inactive people. The few studies conducted in top-level athletes are in accordance with these results. Indeed, it has been demonstrated that international Irish rugby players exhibited a clear higher microbial diversity than inactive and sedentary populations associated to higher production of short-chain fatty acids (SCFA), some key energy substrates produced by commensal bacteria (Clarke et al. 2014; Barton et al. 2018). Conversely, when people are completely physically deconditioned such as astronauts under microgravity or bedridden patients, a clear modification of gut microbiota composition occurs in the gastrointestinal tract (Voorhies and al. 2019). Such differences between top-level athletes, inactive or extremely inactive individuals cannot be only explained to lifestyle, especially diet. Indeed, longitudinal studies have clearly showed that a several weeks training period can increase the gut microbial diversity in humans suggesting an increased capacity of gut microbiota to extract energy from food, especially from dietary fibers (Allen et al. 2018). All together, these data support that the gut microbiota could adapt to the energy needs of the body, really higher in top-level athletes or considerably lower in extremely inactive individuals (e.g. astronauts or bedridden patients). These data also suggest that gut microbiota could punctually inform of the body's metabolic state of an individual.
In this context, this clinical study aims to characterize the bacterial metagenome of gut microbiota from populations located in a continuum from sedentary people to top-level athletes with high (i.e. soccer players), even very high energy needs (i.e. cyclists). The finality of this project is thus to determine if it exists some bacterial profile allowing to characterize, even to predict, the energy metabolism of an athlete and so the probability to be performant in competition.
For this purpose, we will assess the metabolic responses to exercise from different athletic populations (i.e. elite cyclists and soccer players) and non-active of moderately active populations. All the volunteers (n=50) will perform 3 visits in the M2S lab: 1) an inclusion visit including anthropometric measures, dietary and physical activity surveys, and after which the volunteer will leave the lab with a Nahibu kit allowing to send us a fecal sample in the next 7 days, 2) a second visit to perform the incremental cycling test, 3) a last visit to perform metabolic measures in fasted condition in basal and during submaximal exercises. The metabolic parameters measured during these tests (e.g. VO2max, power in aerobic and anaerobic thresholds, maximal carbohydrates and lipids oxidation) will be then related to the metagenomic shotgun data obtained in fecal samples.
- Conditions
- Elite Cyclists, Elite Soccer Players, Sedentary Behavior
- Being tested
- Maximal incremental exercise test, Submaximal exercise test
- Keywords
- Physical activity, Carbohydrates and lipid metabolisms, Gut microbiota, Maximal oxygen consumption
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal incremental exercise testDiagnostic test
Gas exchanges are measured during all the test on ergocycle until oxygen consumption reach its maximum value
Submaximal exercise testDiagnostic test
A 25-min submaximal exercise test on ergocycle under fasting condition. Gas exchanges are measured during all the test.
| Study group | Role | What they receive |
|---|---|---|
| Low active subjects | No intervention Receives: Diagnostic Test: Maximal incremental exercise test; Diagnostic Test: Submaximal exercise test | |
| Moderately active subjects | No intervention Receives: Diagnostic Test: Maximal incremental exercise test; Diagnostic Test: Submaximal exercise test | |
| Elite soccer players | No intervention Receives: Diagnostic Test: Maximal incremental exercise test; Diagnostic Test: Submaximal exercise test | |
| Elite cyclists | No intervention Receives: Diagnostic Test: Maximal incremental exercise test; Diagnostic Test: Submaximal exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition
Whole metagenomic sequencing using shotgun approach
Measured: week 1
Secondary outcomes (6)
Gut microbiota function
Whole metagenomic sequencing using shotgun approach
Measured: Week 1
Short chain fatty acids levels in stools
Quantification of gut microbiota metabolites will be performed in frozen stool suspension using Ultra Performance Liquid Chromatography - Mass spectrometry.
Measured: week 1
Amino acids levels in stools
Quantification of gut microbiota metabolites will be performed in frozen stool suspension using Ultra Performance Liquid Chromatography - Mass spectrometry.
Measured: week 1
Maximal oxygen consumption (VO2max)
Maximal oxygen consumption (ml/min/kg) will be determined during maximal incremental ergocycle test. Gas exchanges will be measured throughout the test.
Measured: Week 2
Lipid oxidation during physical exercise
A submaximal ergocyle test will be performed under fasting condition. After 4 min of warm-up (60W), subjects will perform 10 min at 50% VO2max and a second 10 min step at 90% of the anaerobic threshold. Measurements of respiratory gas exchange will be used to estimate the type and amount of substrate oxidized and the amount of energy produced during exercise (kcal/min).
Measured: week 3
Carbohydrate oxidation during physical exercise
A submaximal ergocyle test will be performed under fasting condition. After 4 min of warm-up (60W), subjects will perform 10 min at 50% VO2max and a second 10 min step at 90% of the anaerobic threshold. Measurements of respiratory gas exchange will be used to estimate the type and amount of substrate oxidized and the amount of energy produced during exercise (kcal/min).
Measured: week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start20 Jan 2022
- Primary completion26 Oct 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Elite CyclistsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rennes 2
- Sponsor type
- University, hospital or other
- Collaborators
- Nahibu
- Responsible party
- Principal investigator, Frédéric Derbré, University of Rennes 2
- Investigators
- Frédéric DERBRÉ, PhD, Principal investigator, Laboratory of Movement, Sport and health Sciences (M2S)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220657
- Sponsor's protocol ID
- 2021-A02496-35
- Acronym
- EXOMIC
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nay K, Jollet M, Goustard B, Baati N, Vernus B, Pontones M, Lefeuvre-Orfila L, Bendavid C, Rue O, Mariadassou M, Bonnieu A, Ollendorff V, Lepage P, Derbre F, Koechlin-Ramonatxo C. Gut bacteria are critical for optimal muscle function: a potential link with glucose homeostasis. Am J Physiol Endocrinol Metab. 2019 Jul 1;317(1):E158-E171. doi: 10.1152/ajpendo.00521.2018. Epub 2019 Apr 30.
PubMed 31039010Clarke SF, Murphy EF, O'Sullivan O, Lucey AJ, Humphreys M, Hogan A, Hayes P, O'Reilly M, Jeffery IB, Wood-Martin R, Kerins DM, Quigley E, Ross RP, O'Toole PW, Molloy MG, Falvey E, Shanahan F, Cotter PD. Exercise and associated dietary extremes impact on gut microbial diversity. Gut. 2014 Dec;63(12):1913-20. doi: 10.1136/gutjnl-2013-306541. Epub 2014 Jun 9.
PubMed 25021423Barton W, Penney NC, Cronin O, Garcia-Perez I, Molloy MG, Holmes E, Shanahan F, Cotter PD, O'Sullivan O. The microbiome of professional athletes differs from that of more sedentary subjects in composition and particularly at the functional metabolic level. Gut. 2018 Apr;67(4):625-633. doi: 10.1136/gutjnl-2016-313627. Epub 2017 Mar 30.
PubMed 28360096Voorhies AA, Mark Ott C, Mehta S, Pierson DL, Crucian BE, Feiveson A, Oubre CM, Torralba M, Moncera K, Zhang Y, Zurek E, Lorenzi HA. Study of the impact of long-duration space missions at the International Space Station on the astronaut microbiome. Sci Rep. 2019 Jul 9;9(1):9911. doi: 10.1038/s41598-019-46303-8.
PubMed 31289321Allen JM, Mailing LJ, Niemiro GM, Moore R, Cook MD, White BA, Holscher HD, Woods JA. Exercise Alters Gut Microbiota Composition and Function in Lean and Obese Humans. Med Sci Sports Exerc. 2018 Apr;50(4):747-757. doi: 10.1249/MSS.0000000000001495.
PubMed 29166320
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between the Gut Microbiome Based Metagenomic Signature, Physical Fitness Levels and Metabolic Responses to Exercise: a Pilot Study on 50 Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05220657
- Acronym / sponsor ID
- EXOMIC / 2021-A02496-35
- Conditions
- Elite Cyclists, Elite Soccer Players, Sedentary Behavior
- Keywords
- Physical activity, Carbohydrates and lipid metabolisms, Gut microbiota, Maximal oxygen consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Rennes 2University, hospital or other
- Collaborators
- Nahibu
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 2 Feb 2022 (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.
Gut microbiota are all microorganisms including bacteria and microscopic eukaryotes that live in the digestive tracts of humans or mammals. During the last decade, some authors highlighted that a link exists between gut microbiota and sport performance. In this project, we hypothesize that gut microbiota is able to adapt to the energy needs of the body, really higher in top-level athletes or considerably lower in inactive individuals. In this context, this clinical study aims to characterize the bacterial metagenome of gut microbiota from populations located in a continuum from sedentary people to top-level athletes with high (i.e. soccer players), even very high energy needs (i.e. cyclists). The finality of this project is thus to determine if it exists some bacterial profile allowing to characterize, even to predict, the energy metabolism of an athlete and so the probability to be performant in competition.
Detailed description
Gut microbiota are all microorganisms including bacteria, archaea and microscopic eukaryotes that live in the digestive tracts of humans or mammals. All these microorganisms live in homeostasis in the gastrointestinal tract and provide a variety of benefits to the host immune system and energy metabolism in a state called eubiosis. On contrary, a state of dysbiosis occurs when the diversity of commensal bacteria is reduced especially in some chronic diseases including obesity, cancer or gastrointestinal diseases. During the last decade, substantial studies highlighted that a link exists between gut microbiota composition and sport performance. Research team especially identified a direct link between gut microbiota and skeletal muscle, a key organ in sport performance (Nay et al. 2019). Using rodent models, They observed that 1) the endurance performance was reduced in mice for which the gut microbiome had been experimentally destructed (Nay et al. 2019), and 2) the reduction of endurance performance was due to lower muscle glycogen levels, a key energy substrate for muscle endurance.
Complementary researches have been conducted in humans to characterize the impact of physical activity on gut microbiota composition and function. A study conducted in large American cohort of 1500 individuals have thus highlighted that the gut microbiota diversity was much more important in individuals performing regular physical activity (3-5 times/week or more) compared to physically inactive people. The few studies conducted in top-level athletes are in accordance with these results. Indeed, it has been demonstrated that international Irish rugby players exhibited a clear higher microbial diversity than inactive and sedentary populations associated to higher production of short-chain fatty acids (SCFA), some key energy substrates produced by commensal bacteria (Clarke et al. 2014; Barton et al. 2018). Conversely, when people are completely physically deconditioned such as astronauts under microgravity or bedridden patients, a clear modification of gut microbiota composition occurs in the gastrointestinal tract (Voorhies and al. 2019). Such differences between top-level athletes, inactive or extremely inactive individuals cannot be only explained to lifestyle, especially diet. Indeed, longitudinal studies have clearly showed that a several weeks training period can increase the gut microbial diversity in humans suggesting an increased capacity of gut microbiota to extract energy from food, especially from dietary fibers (Allen et al. 2018). All together, these data support that the gut microbiota could adapt to the energy needs of the body, really higher in top-level athletes or considerably lower in extremely inactive individuals (e.g. astronauts or bedridden patients). These data also suggest that gut microbiota could punctually inform of the body's metabolic state of an individual.
In this context, this clinical study aims to characterize the bacterial metagenome of gut microbiota from populations located in a continuum from sedentary people to top-level athletes with high (i.e. soccer players), even very high energy needs (i.e. cyclists). The finality of this project is thus to determine if it exists some bacterial profile allowing to characterize, even to predict, the energy metabolism of an athlete and so the probability to be performant in competition.
For this purpose, we will assess the metabolic responses to exercise from different athletic populations (i.e. elite cyclists and soccer players) and non-active of moderately active populations. All the volunteers (n=50) will perform 3 visits in the M2S lab: 1) an inclusion visit including anthropometric measures, dietary and physical activity surveys, and after which the volunteer will leave the lab with a Nahibu kit allowing to send us a fecal sample in the next 7 days, 2) a second visit to perform the incremental cycling test, 3) a last visit to perform metabolic measures in fasted condition in basal and during submaximal exercises. The metabolic parameters measured during these tests (e.g. VO2max, power in aerobic and anaerobic thresholds, maximal carbohydrates and lipids oxidation) will be then related to the metagenomic shotgun data obtained in fecal samples.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low active subjects | – | Diagnostic Test: Maximal incremental exercise test, Diagnostic Test: Submaximal exercise testNo intervention |
| Moderately active subjects | – | Diagnostic Test: Maximal incremental exercise test, Diagnostic Test: Submaximal exercise testNo intervention |
| Elite soccer players | – | Diagnostic Test: Maximal incremental exercise test, Diagnostic Test: Submaximal exercise testNo intervention |
| Elite cyclists | – | Diagnostic Test: Maximal incremental exercise test, Diagnostic Test: Submaximal exercise testNo intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Populations located in a continuum from inactive people to top-level athletes with high (i.e. soccer players) and very high energy needs (i.e. cyclists).
Key inclusion criteria (3 listed)
- BMI between 18 and 25 kg/m²
- Non-smoker
- Written informed consent
Key exclusion criteria (6 listed)
- Cardiovascular risks
- Metabolic diseases (e.g. diabetes)
- Use of antibiotics, anti-fungi or anti-parasites in the last 3 months or during participation in the study
- Use of prebiotics and / or probiotics in the form of supplements in the 7 days preceding the start of the study (greater than or equal to 100000000 Colony Forming Units or organisms per day)
- Taking drug treatment for chronic pain management (paracetamol, vasodilator, homeopathy, aspirin greater than 500 mg per day)
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 |
|---|---|---|
| Maximal incremental exercise testGas exchanges are measured during all the test on ergocycle until oxygen consumption reach its maximum value | Diagnostic test | Elite cyclists, Elite soccer players, Low active subjects, Moderately active subjects |
| Submaximal exercise testA 25-min submaximal exercise test on ergocycle under fasting condition. Gas exchanges are measured during all the test. | Diagnostic test | Elite cyclists, Elite soccer players, Low active subjects, Moderately active subjects |
Primary outcome
Gut microbiota composition
Time frame: week 1
Whole metagenomic sequencing using shotgun approach
6 secondary outcomes
Gut microbiota function
Time frame: Week 1
Short chain fatty acids levels in stools
Time frame: week 1
Amino acids levels in stools
Time frame: week 1
Maximal oxygen consumption (VO2max)
Time frame: Week 2
Lipid oxidation during physical exercise
Time frame: week 3
Carbohydrate oxidation during physical exercise
Time frame: week 3
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 10 Jan 2023.
- Background: PubMed 31039010Nay K, Jollet M, Goustard B, Baati N, Vernus B, Pontones M, Lefeuvre-Orfila L, Bendavid C, Rue O, Mariadassou M, Bonnieu A, Ollendorff V, Lepage P, Derbre F, Koechlin-Ramonatxo C. Gut bacteria are critical for optimal muscle function: a potential link with glucose homeostasis. Am J Physiol Endocrinol Metab. 2019 Jul 1;317(1):E158-E171. doi: 10.1152/ajpendo.00521.2018. Epub 2019 Apr 30.
- Background: PubMed 25021423Clarke SF, Murphy EF, O'Sullivan O, Lucey AJ, Humphreys M, Hogan A, Hayes P, O'Reilly M, Jeffery IB, Wood-Martin R, Kerins DM, Quigley E, Ross RP, O'Toole PW, Molloy MG, Falvey E, Shanahan F, Cotter PD. Exercise and associated dietary extremes impact on gut microbial diversity. Gut. 2014 Dec;63(12):1913-20. doi: 10.1136/gutjnl-2013-306541. Epub 2014 Jun 9.
- Background: PubMed 28360096Barton W, Penney NC, Cronin O, Garcia-Perez I, Molloy MG, Holmes E, Shanahan F, Cotter PD, O'Sullivan O. The microbiome of professional athletes differs from that of more sedentary subjects in composition and particularly at the functional metabolic level. Gut. 2018 Apr;67(4):625-633. doi: 10.1136/gutjnl-2016-313627. Epub 2017 Mar 30.
- Background: PubMed 31289321Voorhies AA, Mark Ott C, Mehta S, Pierson DL, Crucian BE, Feiveson A, Oubre CM, Torralba M, Moncera K, Zhang Y, Zurek E, Lorenzi HA. Study of the impact of long-duration space missions at the International Space Station on the astronaut microbiome. Sci Rep. 2019 Jul 9;9(1):9911. doi: 10.1038/s41598-019-46303-8.
- Background: PubMed 29166320Allen JM, Mailing LJ, Niemiro GM, Moore R, Cook MD, White BA, Holscher HD, Woods JA. Exercise Alters Gut Microbiota Composition and Function in Lean and Obese Humans. Med Sci Sports Exerc. 2018 Apr;50(4):747-757. doi: 10.1249/MSS.0000000000001495.
- Individual participant dataSharing planned: No
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.
Frédéric DERBRÉ, PhD principal investigator
Laboratory of Movement, Sport and health Sciences (M2S)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elite Cyclists and Elite Soccer Players, run by University of Rennes 2 at 1 site in France.
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 6 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 10 Jan 2023. 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 France. 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. 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?
Gut microbiota composition (time frame: week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220657, which also lists 5 linked publications.
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 10 Jan 2023.