Healthy Adult ParticipantsDORANCT07575529
DORA - A Study Using Digital Health Tools/Platform to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals
A study testing Synbiotic Nutritional Product in people with Healthy Adult Participants and Gut Microbiomes, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
Trial summary
The DORA study is a single-arm, open-label, interventional exploratory study designed to evaluate the impact of a synbiotic-containing senior milk powder on the gut microbiome and selected biological, physiological, and digital health parameters in community-living adults in good health. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Gut Microbiomes, AI
- What is being tested?
- Synbiotic Nutritional Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged between 40 to 65 years (bounds included)
- Participants who are community-living
- Participants who are in good health (self-reported)
- Participants own and are willing to use their personal non-shared mobile device (iPhone 8 or later, with iOS version 16 or later), to pair with the study-provided Apple Watch SE, for the duration of the study
- Participant should be able to use mobile applications on smartphones to perform tasks in the study, have access to the internet and a smartphone or tablet to take and upload images and/or videos of stool, and other anatomical sites
- Participant should be able to comprehend the content of the study and to complete the study questionnaires in English
Show all 9Show fewer
- Written and signed consent from participant
- Currently reside in Singapore and with the intention to reside in Singapore for at least the duration of the study.
- Note: Clinical trial participants may be permitted to undertake short-duration travel not exceeding 72 consecutive hours each time, provided such travel does not conflict with scheduled study visits, investigational product administration, or protocol-defined assessments. Prior notification to principal investigator or designated study personnel is required. The participant must be instructed on potential risks, adverse event reporting during the travel period.
Who cannot join
- Pregnant or lactating, or wish to become pregnant during the period of the study (self-reported)
- Participant with current or intended participation in a clinical study involving investigational or marketed products
- Use of named prebiotics, probiotics or synbiotics (in a capsule or sachet) within the last 4 weeks prior to screening or are planning to use it during the study including but not limited to the products listed below:
- BioGaia Probiotic Tablets
- LACTO FIT Probiotics
- Nano Singapore Digestive Wellness Formula
Show all 28Show fewer
- California Gold Nutrition LactoBif Probiotics
- Life Space Probiotic
- Vivomixx 112.5 Billion Live Probiotics
- Duolac Daily Vitality Probiotic
- ATOMY Probiotics 10+
- Blackmores Ultra Max Probiotics+
- Holistic Way High Strength Probiotic 75 Billion
- Use of any commercial healthy aging milk powder within the last 4 weeks prior to screening or are planning to use it during the study including but not limited to:
- Boost Optimum
- Enercal complete
- Anlene
- Ensure
- Use of systemic antibiotics within the last 8 weeks prior to screening
- Known allergy or intolerance to Galactooligosaccharides (GOS), lactose, probiotics, or any ingredient in the SP
- Gastrointestinal (GI) surgery within the last 6 months prior to screening
- BMI below 18.5 kg/m² or above 27.5 kg/m²
- Participants who are using insulin, or have poorly controlled diabetes (HbA1c ≥ 10%) within last 3 months prior to screening
- Other severe disease(s) impairing activities of daily living or affecting the ability to complete the study assessments such as malignancy, end stage organ failure, COPD on long-term oxygen therapy, stroke with significantly residual functional weakness, cardiac failure with poor effort tolerance, significant neurological disease such as cognitive impairment from dementia, severe neuromuscular disease like Parkinson's disease, psychiatric disease/disorder, auto-immune disease, allergic conditions requiring chronic systemic medication, other severe GI disease(s) such as Crohn's disease, GI cancer, or ulcerative colitis diagnosed by a physician
- History of drug abuse (Drug Abuse Screening Test (DAST) score of >2) or alcohol abuse (Alcohol Use Disorders Identification Test (AUDIT) score of > 7) within the last 6 months prior to screening
- Participants on a special diet, e.g., vegan, low-carbohydrate for intentional weight loss, ketogenic, low-FODMAP diet at the screening visit, or plan for such diet during the study duration
- Employees and/or children/family members or relatives of employees of Danone or the study team members (dependent relationship with study team members) participating sites such as, employees of the Investigator or of the Sponsor, members of the armed forces, and persons kept in detention
- Participant expected to be living in the same home as a current participating participant and to concomitantly receive SP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Woodland Hospital
Singapore
Bryan Tan, MBBS, +65 63633000, wh.enquiry@nhghealth.com.sg
Bryan Tan, MBBS
About this study
Official title: DORA - An Exploratory, Interventional Study Using Digital Health Tools and OneBiome to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals
The DORA study is a single-arm, open-label, interventional exploratory study designed to evaluate the impact of a synbiotic-containing senior milk powder on the gut microbiome and selected biological, physiological, and digital health parameters in community-living adults in good health.
The study enrolls adults aged 40 to 65 years and aims to investigate changes in gut microbial composition, with a primary focus on butyrate-producing microbial taxa, following at least 28 days of study product consumption. Secondary and exploratory objectives include assessment of stool metabolites, blood-based biomarkers, bowel patterns, sleep quality, physical activity, cognitive function, dietary patterns, and quality of life.
Read more
Approximately 125 participants will be recruited in Singapore to achieve 100 study completers. Following informed consent and screening, participants undergo a baseline observation period of 14 days during which physiological and lifestyle data are collected using wearable digital health devices. Baseline assessments also include blood sampling, stool collection for microbiome analysis, digital imaging and videography, and completion of validated questionnaires.
After completion of baseline assessments and collection of the first stool sample, participants initiate consumption of the study product, a senior milk powder containing a defined synbiotic formulation. The study product is consumed twice daily for a minimum of 28 days and up to 35 days to allow completion of study assessments.
Participants return for end-of-intervention assessments following the study product phase, including repeat biological sampling, physical and digital assessments, and questionnaires. Stool microbiome profiles and other exploratory outcomes are compared between baseline and post-intervention time points.
This exploratory study is intended to generate feasibility data and hypotheses regarding the effects of synbiotic nutritional intervention and the integration of biological and digital health data in the context of healthy aging.
Read the detailed description
Aging is a multifactorial biological process influenced by genetic, metabolic, environmental, and lifestyle factors. Increasing evidence suggests that the gut microbiome plays an important role in healthy aging, with associations reported across metabolic health, immune regulation, inflammatory processes, bowel function, cognition, and overall physiological resilience. Specific gut microbial communities, have been associated with favorable health outcomes and markers of healthy aging.
Synbiotics combine probiotics with complementary prebiotic substrates and are intended to selectively enhance beneficial gut microbial populations. The study product evaluated in the DORA study is a senior milk powder containing a defined synbiotic formulation.
Advances in digital health technologies now enable continuous and remote assessment of physiological, behavioral, and lifestyle parameters in daily living environments. The integration of wearable devices, mobile applications, and biological sampling allows the generation of longitudinal, multidimensional datasets. These approaches support exploratory research into physiological patterns relevant to healthy aging and facilitate investigation of potential digital biomarkers.
The DORA study is designed as an exploratory, single-arm nutritional intervention study to examine the effects of synbiotic consumption on gut microbiome-related outcomes in community-living adults in good health. The primary scientific focus is on gut microbiome composition, especially microbial taxa associated with short-chain fatty acid production. In addition, the study explores relationships between gut microbiome features and a range of biological, physiological, behavioral, and digital health parameters.
Participants undergo a baseline observation phase prior to study product initiation to characterize habitual health patterns and support within-participant comparisons over time. Following the intervention period, post-intervention assessments allow exploratory evaluation of changes relative to baseline. This longitudinal framework is intended to support descriptive and association-based analyses rather than formal hypothesis testing.
Beyond microbiome-related outcomes, the study includes exploratory assessments of stool-derived metabolites, blood-based biological biomarkers, bowel habits, dietary intake, sleep, physical activity, cognition, and quality of life. Digital health tools are used to capture continuous or near-continuous physiological and behavioral data, including activity, sleep patterns, heart rate-related measures, oxygen saturation, respiratory parameters, mobility metrics, and glucose profiles.
An additional exploratory component of the study is the integration of biological, clinical, and digital health data to support development of composite indicators and exploratory analytical models. Image-, video-, and sensor-based data are collected to assess feasibility and accuracy of advanced analytical approaches, including exploratory artificial intelligence methods. These analyses are conducted for research purposes only and are not intended for diagnostic or clinical decision-making.
The DORA study is exploratory in nature and is not designed to establish clinical efficacy, validate diagnostic tools, or demonstrate causal relationships. Findings will be interpreted descriptively, with emphasis on feasibility, data integration, variability, and observed associations. Results are intended to inform hypothesis generation, methodological development, and the design of future studies investigating nutritional strategies and digitally enabled assessment approaches in the context of healthy aging.
- Conditions
- Healthy Adult Participants, Gut Microbiomes, AI
- Being tested
- Synbiotic Nutritional Product
- Keywords
- Healthy Aging, Gut Microbiome, Gut Health, Probiotics, Prebiotics, Nutritional Intervention, Microbiome Profiling, Digital Health, Wearable Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic Nutritional ProductDietary supplement
Participants receive a nutritional product administered as a senior milk powder. The study product contains a defined combination of probiotic and prebiotic components and is consumed twice daily following a baseline observation period. The intervention is provided to all participants during the intervention phase as part of an exploratory nutrition study in healthy adults. No placebo or comparator intervention is included.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention | Experimental | Participants in this arm receive the study product, a synbiotic-based senior milk powder, consumed twice daily following a baseline observation period. The study product contains a defined combination of probiotic and prebiotic components and is administered to all participants for the duration of the intervention phase as part of an exploratory nutritional study in healthy adults. Receives: Dietary Supplement: Synbiotic Nutritional Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relative abundance of gut microbiome composition
Change from baseline in the relative abundance of gut microbiome composition following consumption of the synbiotic nutritional product.
Measured: Baseline and end of intervention (after at least 28 days of study product consumption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start27 Apr 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory analytical models are used in this study to examine relationships among gut microbiome profiles, stool- and blood-based biological markers, questionnaire-derived measures, and digital health data collected longitudinally in healthy adults. The modeling framework integrates multimodal data sources, including microbiome sequencing outputs and wearable- and sensor-derived physiological parameters, to support descriptive and associative analyses. The study follows a single-arm, open-label interventional model with a baseline observation period prior to initiation of the synbiotic nutritional intervention. This within-participant longitudinal design allows each participant to serve as their own reference, enabling exploratory comparison of post-intervention measures relative to baseline. All models are research-focused and exploratory in nature and are not designed, trained, or validated for diagnostic, prognostic, screening, or clinical decision-making purposes.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Woodlands Hospital
- Responsible party
- Sponsor
- Investigators
- Bryan Tan, Principal investigator, Woodlands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575529
- Sponsor's protocol ID
- 24REX0079694
- Acronym
- DORA
- Status last verified
- Jul 2026
- First submitted
- 4 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Data collected in this study will be used solely for the purposes described in the protocol and handled in accordance with applicable data protection regulations and data processing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DORA - An Exploratory, Interventional Study Using Digital Health Tools and OneBiome to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals
- ClinicalTrials.gov ID
- NCT07575529
- Acronym / sponsor ID
- DORA / 24REX0079694
- Conditions
- Healthy Adult Participants, Gut Microbiomes, AI
- Keywords
- Healthy Aging, Gut Microbiome, Gut Health, Probiotics, Prebiotics, Nutritional Intervention, Microbiome Profiling, Digital Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Woodlands Hospital
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 May 2026 (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.
The DORA study is a single-arm, open-label, interventional exploratory study designed to evaluate the impact of a synbiotic-containing senior milk powder on the gut microbiome and selected biological, physiological, and digital health parameters in community-living adults in good health.
The study enrolls adults aged 40 to 65 years and aims to investigate changes in gut microbial composition, with a primary focus on butyrate-producing microbial taxa, following at least 28 days of study product consumption. Secondary and exploratory objectives include assessment of stool metabolites, blood-based biomarkers, bowel patterns, sleep quality, physical activity, cognitive function, dietary patterns, and quality of life.
Approximately 125 participants will be recruited in Singapore to achieve 100 study completers. Following informed consent and screening, participants undergo a baseline observation period of 14 days during which physiological and lifestyle data are collected using wearable digital health devices. Baseline assessments also include blood sampling, stool collection for microbiome analysis, digital imaging and videography, and completion of validated questionnaires.
After completion of baseline assessments and collection of the first stool sample, participants initiate consumption of the study product, a senior milk powder containing a defined synbiotic formulation. The study product is consumed twice daily for a minimum of 28 days and up to 35 days to allow completion of study assessments.
Participants return for end-of-intervention assessments following the study product phase, including repeat biological sampling, physical and digital assessments, and questionnaires. Stool microbiome profiles and other exploratory outcomes are compared between baseline and post-intervention time points.
This exploratory study is intended to generate feasibility data and hypotheses regarding the effects of synbiotic nutritional intervention and the integration of biological and digital health data in the context of healthy aging.
Detailed description
Aging is a multifactorial biological process influenced by genetic, metabolic, environmental, and lifestyle factors. Increasing evidence suggests that the gut microbiome plays an important role in healthy aging, with associations reported across metabolic health, immune regulation, inflammatory processes, bowel function, cognition, and overall physiological resilience. Specific gut microbial communities, have been associated with favorable health outcomes and markers of healthy aging.
Synbiotics combine probiotics with complementary prebiotic substrates and are intended to selectively enhance beneficial gut microbial populations. The study product evaluated in the DORA study is a senior milk powder containing a defined synbiotic formulation.
Advances in digital health technologies now enable continuous and remote assessment of physiological, behavioral, and lifestyle parameters in daily living environments. The integration of wearable devices, mobile applications, and biological sampling allows the generation of longitudinal, multidimensional datasets. These approaches support exploratory research into physiological patterns relevant to healthy aging and facilitate investigation of potential digital biomarkers.
The DORA study is designed as an exploratory, single-arm nutritional intervention study to examine the effects of synbiotic consumption on gut microbiome-related outcomes in community-living adults in good health. The primary scientific focus is on gut microbiome composition, especially microbial taxa associated with short-chain fatty acid production. In addition, the study explores relationships between gut microbiome features and a range of biological, physiological, behavioral, and digital health parameters.
Participants undergo a baseline observation phase prior to study product initiation to characterize habitual health patterns and support within-participant comparisons over time. Following the intervention period, post-intervention assessments allow exploratory evaluation of changes relative to baseline. This longitudinal framework is intended to support descriptive and association-based analyses rather than formal hypothesis testing.
Beyond microbiome-related outcomes, the study includes exploratory assessments of stool-derived metabolites, blood-based biological biomarkers, bowel habits, dietary intake, sleep, physical activity, cognition, and quality of life. Digital health tools are used to capture continuous or near-continuous physiological and behavioral data, including activity, sleep patterns, heart rate-related measures, oxygen saturation, respiratory parameters, mobility metrics, and glucose profiles.
An additional exploratory component of the study is the integration of biological, clinical, and digital health data to support development of composite indicators and exploratory analytical models. Image-, video-, and sensor-based data are collected to assess feasibility and accuracy of advanced analytical approaches, including exploratory artificial intelligence methods. These analyses are conducted for research purposes only and are not intended for diagnostic or clinical decision-making.
The DORA study is exploratory in nature and is not designed to establish clinical efficacy, validate diagnostic tools, or demonstrate causal relationships. Findings will be interpreted descriptively, with emphasis on feasibility, data integration, variability, and observed associations. Results are intended to inform hypothesis generation, methodological development, and the design of future studies investigating nutritional strategies and digitally enabled assessment approaches in the context of healthy aging.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory analytical models are used in this study to examine relationships among gut microbiome profiles, stool- and blood-based biological markers, questionnaire-derived measures, and digital health data collected longitudinally in healthy adults. The modeling framework integrates multimodal data sources, including microbiome sequencing outputs and wearable- and sensor-derived physiological parameters, to support descriptive and associative analyses. The study follows a single-arm, open-label interventional model with a baseline observation period prior to initiation of the synbiotic nutritional intervention. This within-participant longitudinal design allows each participant to serve as their own reference, enabling exploratory comparison of post-intervention measures relative to baseline. All models are research-focused and exploratory in nature and are not designed, trained, or validated for diagnostic, prognostic, screening, or clinical decision-making purposes.
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention | Experimental | Dietary Supplement: Synbiotic Nutritional ProductParticipants in this arm receive the study product, a synbiotic-based senior milk powder, consumed twice daily following a baseline observation period. The study product contains a defined combination of probiotic and prebiotic components and is administered to all participants for the duration of the intervention phase as part of an exploratory nutritional study in healthy adults. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants aged between 40 to 65 years (bounds included)
- Participants who are community-living
- Participants who are in good health (self-reported)
- Participants own and are willing to use their personal non-shared mobile device (iPhone 8 or later, with iOS version 16 or later), to pair with the study-provided Apple Watch SE, for the duration of the study
- Participant should be able to use mobile applications on smartphones to perform tasks in the study, have access to the internet and a smartphone or tablet to take and upload images and/or videos of stool, and other anatomical sites
Key exclusion criteria (28 listed)
- Pregnant or lactating, or wish to become pregnant during the period of the study (self-reported)
- Participant with current or intended participation in a clinical study involving investigational or marketed products
- Use of named prebiotics, probiotics or synbiotics (in a capsule or sachet) within the last 4 weeks prior to screening or are planning to use it during the study including but not limited to the products listed below:
- Use of any commercial healthy aging milk powder within the last 4 weeks prior to screening or are planning to use it during the study including but not limited to:
- Use of systemic antibiotics within the last 8 weeks prior to screening
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 |
|---|---|---|
| Synbiotic Nutritional ProductParticipants receive a nutritional product administered as a senior milk powder. The study product contains a defined combination of probiotic and prebiotic components and is consumed twice daily following a baseline observation period. The intervention is provided to all participants during the intervention phase as part of an exploratory nutrition study in healthy adults. No placebo or comparator intervention is included. | Dietary supplement | Nutritional intervention |
Primary outcome
Change in relative abundance of gut microbiome composition
Time frame: Baseline and end of intervention (after at least 28 days of study product consumption)
Change from baseline in the relative abundance of gut microbiome composition following consumption of the synbiotic nutritional product.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Data collected in this study will be used solely for the purposes described in the protocol and handled in accordance with applicable data protection regulations and data processing agreements.
Related trials for Healthy Adult Participants
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Active, not recruitingPhase 1
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
Healthy Volunteers, Hyperuricemia
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
Enrolling by invitationEarly Phase 1
Acute Effects of a Single Dose of Ayahuasca on Cerebral Metabolism in Healthy Volunteers: a PET Study
Healthy Adult Participants
RecruitingPhase 1
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Renal Impairment, Healthy Volunteers
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.
Bryan Tan principal investigator
Woodlands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic Nutritional Product in people with Healthy Adult Participants and Gut Microbiomes, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
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 9 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Bing Tan (+6596771523, LiBing.TAN@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in relative abundance of gut microbiome composition (time frame: Baseline and end of intervention (after at least 28 days of study product consumption)). 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 3 Aug 2026.