Healthy ParticipantsNCT07840066
Probiotics in Wellbeing
A study testing Probiotic Supplementation (Lactobacillus plantarum) in people with Healthy Participants, run by University of Reading at 1 site in United Kingdom.
Trial summary
This study will investigate whether taking a probiotic supplement every day for 12 weeks can reduce low-level inflammation and improve wellbeing in generally healthy adults. Forty adults will be randomly assigned to receive either a probiotic capsule or a placebo capsule that looks the same but does not contain… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Probiotic Supplementation (Lactobacillus plantarum)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2026to Sep 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy adults
- Aged 18 to 60 years
- Body mass index (BMI) 18.5 to 30 kg/m²
Who cannot join
- Antibiotic use within the previous 3 months
- Chronic gastrointestinal disorders
- Chronic immune disorders
- Current probiotic or prebiotic use
- Current use of immunomodulatory medication
- Pregnancy or lactation
- Relevant allergies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Reading
Reading, Berkshire, RG66DX
About this study
Official title: A Randomised Controlled Trial Investigating the Probiotic-mediated Suppression of Inflammatory Cytokines as a Mechanism for Improving Wellbeing
This study will investigate whether taking a probiotic supplement every day for 12 weeks can reduce low-level inflammation and improve wellbeing in generally healthy adults.
Forty adults will be randomly assigned to receive either a probiotic capsule or a placebo capsule that looks the same but does not contain probiotic bacteria. Neither the participants nor the researchers involved in the study will know which treatment each participant receives until the study is completed.
Read more
Participants will attend a study visit before starting the supplement and another visit after 12 weeks, with a remote check midway through the study. Blood samples will be collected to measure markers of inflammation and stress. Stool samples will be collected to assess the gut microbiota and substances produced by gut bacteria. Urine samples will also be collected to measure metabolites, which are small molecules produced by normal processes in the body and by interactions between the body, diet and gut microbiota. Participants will also complete questionnaires about wellbeing, mood, anxiety, quality of life and memory.
The main aim of the study is to determine whether the probiotic reduces a combined measure of several markers of inflammation compared with placebo. The study will also explore whether changes in inflammation are associated with changes in wellbeing and memory, and whether these effects are accompanied by changes in the gut microbiota or in metabolic profiles measured in stool and urine.
The results will help researchers understand how probiotics may influence communication between the gut, immune system and brain, and will provide information to help design a larger clinical trial.
Read the detailed description
The gut microbiota can influence host immune function through interactions with the intestinal barrier, microbial metabolites and systemic immune signalling. In turn, systemic inflammatory mediators have been associated with mood, wellbeing and cognitive function. This study will investigate a proposed gut-immune-brain pathway in which modulation of the gut environment by a probiotic intervention may alter systemic inflammatory signalling and thereby influence psychological wellbeing and cognitive function.
This is a 12-week, randomised, double-blind, placebo-controlled, parallel-arm pilot study in 40 generally healthy adults. Following baseline assessments, participants will be randomly allocated to receive either a daily multi-strain probiotic supplement or a matched placebo for 12 weeks. Assessments will take place at baseline and at the end of the 12-week intervention, with a remote adherence and tolerability check approximately halfway through the intervention.
The primary objective is to determine whether probiotic supplementation reduces systemic pro-inflammatory activity compared with placebo. The primary endpoint is the change from baseline to week 12 in a pre-specified pro-inflammatory composite comprising IL-6, TNF-α, IL-1β, IL-8, IFN-γ and high-sensitivity C-reactive protein (hsCRP). Each marker will be standardised relative to its baseline variability and combined into a direction-consistent composite in which higher values indicate greater inflammatory activity.
Secondary assessments will include the anti-inflammatory cytokine IL-10, serum cortisol and validated questionnaires assessing quality of life, depressive symptoms, anxiety, wellbeing and prospective and retrospective memory.
Exploratory mechanistic outcomes will include faecal short-chain fatty acids and related organic acids measured by gas chromatography-mass spectrometry, quantification of selected major bacterial groups using fluorescence in situ hybridisation coupled with flow cytometry, and descriptive 16S rRNA gene sequencing to characterise gut microbial community features. Urine samples collected at baseline and week 12 will undergo nuclear magnetic resonance (NMR) spectroscopy-based metabolomic profiling to assess changes in urinary metabolites associated with the intervention. These analyses will provide an additional measure of host-microbial metabolic activity and will be explored in relation to changes in the gut microbiota, inflammatory markers and wellbeing outcomes.
The study will additionally examine whether within-person reductions in the pro-inflammatory composite are associated with improvements in wellbeing and cognitive measures, whether this relationship differs between the probiotic and placebo groups, and whether baseline inflammatory status modifies the response to the intervention. Exploratory mediation analyses will investigate whether changes in inflammatory activity may partly account for any observed effect of the intervention on wellbeing.
By integrating measures of gut microbial composition and activity, faecal and urinary metabolite profiles, systemic immune signalling and psychological outcomes within a controlled intervention study, the trial aims to improve mechanistic understanding of communication along the gut-immune-brain axis and to provide effect-size and feasibility data for a future larger randomised controlled trial.
- Conditions
- Healthy Participants
- Being tested
- Probiotic Supplementation (Lactobacillus plantarum), Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Supplementation (Lactobacillus plantarum)Dietary supplement
Also called Optibac Every Day Probiotic
Daily oral administration of one capsule of a multi-strain probiotic supplement (Optibac "Every Day") for 12 weeks. Each daily dose provides 5 × 10⁹ CFU and contains Lactobacillus rhamnosus Rosell-11 (R0011), Lactobacillus acidophilus/helveticus Rosell-52 (R0052), Bifidobacterium longum Rosell-175 (R0175), Bifidobacterium breve Rosell-70 (R0070), Bifidobacterium bifidum Rosell-71 (R0071), and Lactococcus lactis Rosell-1058 (R1058), together with fructooligosaccharides (FOS). Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling.
Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention.Dietary supplement
Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention in capsule shell, appearance and fill weight. Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling.
| Study group | Role | What they receive |
|---|---|---|
| Vegan capsules filled with potato starch only. | Placebo comparator | Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention in capsule shell, appearance and fill weight. Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling. Receives: Dietary Supplement: Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention. |
| Probiotic supplement | Experimental | Daily oral administration of one capsule of a multi-strain probiotic supplement (Optibac "Every Day") for 12 weeks. Each daily dose provides 5 × 10⁹ CFU and contains Lactobacillus rhamnosus Rosell-11 (R0011), Lactobacillus acidophilus/helveticus Rosell-52 (R0052), Bifidobacterium longum Rosell-175 (R0175), Bifidobacterium breve Rosell-70 (R0070), Bifidobacterium bifidum Rosell-71 (R0071), and Lactococcus lactis Rosell-1058 (R1058), together with fructooligosaccharides (FOS). Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling. Receives: Dietary Supplement: Probiotic Supplementation (Lactobacillus plantarum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in standardised pro-inflammatory biomarker composite
Change from baseline to Week 12 in a pre-specified pro-inflammatory composite comprising IL-6, TNF-α, IL-1β, IL-8, IFN-γ and high-sensitivity C-reactive protein (hsCRP). Each biomarker will be standardised relative to its baseline distribution and the composite calculated as the mean of direction-consistent z-scores. This is a study-defined continuous composite rather than a bounded clinical scale; therefore, it has no fixed theoretical minimum or maximum. Higher composite values indicate greater systemic inflammatory activity, and a negative change from baseline indicates a reduction in inflammatory activity. The between-group change will be compared between the probiotic and placebo groups.
Measured: Baseline and Week 12
Secondary outcomes (8)
Change in plasma IL-10 concentration
Change from baseline to Week 12 in plasma interleukin-10 (IL-10), an anti-inflammatory cytokine. IL-10 will be assessed as a secondary marker of anti-inflammatory immune activity.
Measured: Baseline and Week 12
Change in serum cortisol concentration
Change from baseline to Week 12 in serum cortisol concentration as a secondary measure related to physiological stress responses.
Measured: Baseline and Week 12
Change in 12-Item Short Form Health Survey Mental Component Summary score
Change from baseline to Week 12 in mental health-related quality of life assessed using the 12-Item Short Form Health Survey, Version 1 (SF-12v1) Mental Component Summary (MCS). MCS scores range from 0 to 100, with higher scores indicating better mental health-related quality of life. Change will be calculated as Week 12 minus baseline; a positive change indicates improvement.
Measured: Baseline and Week 12
Change in 12-Item Short Form Health Survey Physical Component Summary score
Change from baseline to Week 12 in physical health-related quality of life assessed using the 12-Item Short Form Health Survey, Version 1 (SF-12v1) Physical Component Summary (PCS). PCS scores range from 0 to 100, with higher scores indicating better physical health-related quality of life. Change will be calculated as Week 12 minus baseline; a positive change indicates improvement.
Measured: Baseline and Week 12
Change in Patient Health Questionnaire-9 total score
Change from baseline to Week 12 in depressive symptom severity assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity. Change is calculated as Week 12 minus baseline; a negative change indicates improvement.
Measured: Baseline and Week 12
Change in Generalized Anxiety Disorder-7 total score
Change from baseline to Week 12 in anxiety symptom severity assessed using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 total score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity. Change is calculated as Week 12 minus baseline; a negative change indicates improvement.
Measured: Baseline and Week 12
Change in World Health Organization-Five Well-Being Index score
Change from baseline to Week 12 in psychological wellbeing assessed using the World Health Organization-Five Well-Being Index (WHO-5). The raw WHO-5 score ranges from 0 to 25, with higher scores indicating better mental wellbeing. Change is calculated as Week 12 minus baseline; a positive change indicates improvement.
Measured: Baseline and Week 12
Change in Prospective and Retrospective Memory Questionnaire total score
Change from baseline to Week 12 in self-reported everyday memory failures assessed using the 16-item Prospective and Retrospective Memory Questionnaire (PRMQ). The total PRMQ score ranges from 16 to 80, with higher scores indicating more frequent self-reported memory failures and therefore a worse outcome. Change is calculated as Week 12 minus baseline; a negative change indicates improvement.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Sep 2026
- Primary completion1 Aug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, randomised, double-blind, placebo-controlled, parallel-group study. Participants will be allocated 1:1 to receive either a daily multi-strain probiotic supplement or matched placebo for 12 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Wren Laboratories LLC
- Responsible party
- Principal investigator, Patricia Sanz Morales, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840066
- Sponsor's protocol ID
- 26/20
- Other IDs
- UKRI775
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Investigating the Probiotic-mediated Suppression of Inflammatory Cytokines as a Mechanism for Improving Wellbeing
- ClinicalTrials.gov ID
- NCT07840066
- Acronym / sponsor ID
- 26/20
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Wren Laboratories LLC
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Sep 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.
This study will investigate whether taking a probiotic supplement every day for 12 weeks can reduce low-level inflammation and improve wellbeing in generally healthy adults.
Forty adults will be randomly assigned to receive either a probiotic capsule or a placebo capsule that looks the same but does not contain probiotic bacteria. Neither the participants nor the researchers involved in the study will know which treatment each participant receives until the study is completed.
Participants will attend a study visit before starting the supplement and another visit after 12 weeks, with a remote check midway through the study. Blood samples will be collected to measure markers of inflammation and stress. Stool samples will be collected to assess the gut microbiota and substances produced by gut bacteria. Urine samples will also be collected to measure metabolites, which are small molecules produced by normal processes in the body and by interactions between the body, diet and gut microbiota. Participants will also complete questionnaires about wellbeing, mood, anxiety, quality of life and memory.
The main aim of the study is to determine whether the probiotic reduces a combined measure of several markers of inflammation compared with placebo. The study will also explore whether changes in inflammation are associated with changes in wellbeing and memory, and whether these effects are accompanied by changes in the gut microbiota or in metabolic profiles measured in stool and urine.
The results will help researchers understand how probiotics may influence communication between the gut, immune system and brain, and will provide information to help design a larger clinical trial.
Detailed description
The gut microbiota can influence host immune function through interactions with the intestinal barrier, microbial metabolites and systemic immune signalling. In turn, systemic inflammatory mediators have been associated with mood, wellbeing and cognitive function. This study will investigate a proposed gut-immune-brain pathway in which modulation of the gut environment by a probiotic intervention may alter systemic inflammatory signalling and thereby influence psychological wellbeing and cognitive function.
This is a 12-week, randomised, double-blind, placebo-controlled, parallel-arm pilot study in 40 generally healthy adults. Following baseline assessments, participants will be randomly allocated to receive either a daily multi-strain probiotic supplement or a matched placebo for 12 weeks. Assessments will take place at baseline and at the end of the 12-week intervention, with a remote adherence and tolerability check approximately halfway through the intervention.
The primary objective is to determine whether probiotic supplementation reduces systemic pro-inflammatory activity compared with placebo. The primary endpoint is the change from baseline to week 12 in a pre-specified pro-inflammatory composite comprising IL-6, TNF-α, IL-1β, IL-8, IFN-γ and high-sensitivity C-reactive protein (hsCRP). Each marker will be standardised relative to its baseline variability and combined into a direction-consistent composite in which higher values indicate greater inflammatory activity.
Secondary assessments will include the anti-inflammatory cytokine IL-10, serum cortisol and validated questionnaires assessing quality of life, depressive symptoms, anxiety, wellbeing and prospective and retrospective memory.
Exploratory mechanistic outcomes will include faecal short-chain fatty acids and related organic acids measured by gas chromatography-mass spectrometry, quantification of selected major bacterial groups using fluorescence in situ hybridisation coupled with flow cytometry, and descriptive 16S rRNA gene sequencing to characterise gut microbial community features. Urine samples collected at baseline and week 12 will undergo nuclear magnetic resonance (NMR) spectroscopy-based metabolomic profiling to assess changes in urinary metabolites associated with the intervention. These analyses will provide an additional measure of host-microbial metabolic activity and will be explored in relation to changes in the gut microbiota, inflammatory markers and wellbeing outcomes.
The study will additionally examine whether within-person reductions in the pro-inflammatory composite are associated with improvements in wellbeing and cognitive measures, whether this relationship differs between the probiotic and placebo groups, and whether baseline inflammatory status modifies the response to the intervention. Exploratory mediation analyses will investigate whether changes in inflammatory activity may partly account for any observed effect of the intervention on wellbeing.
By integrating measures of gut microbial composition and activity, faecal and urinary metabolite profiles, systemic immune signalling and psychological outcomes within a controlled intervention study, the trial aims to improve mechanistic understanding of communication along the gut-immune-brain axis and to provide effect-size and feasibility data for a future larger randomised controlled trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, randomised, double-blind, placebo-controlled, parallel-group study. Participants will be allocated 1:1 to receive either a daily multi-strain probiotic supplement or matched placebo for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Vegan capsules filled with potato starch only. | Placebo comparator | Dietary Supplement: Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention.Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention in capsule shell, appearance and fill weight. Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling. |
| Probiotic supplement | Experimental | Dietary Supplement: Probiotic Supplementation (Lactobacillus plantarum)Daily oral administration of one capsule of a multi-strain probiotic supplement (Optibac "Every Day") for 12 weeks. Each daily dose provides 5 × 10⁹ CFU and contains Lactobacillus rhamnosus Rosell-11 (R0011), Lactobacillus acidophilus/helveticus Rosell-52 (R0052), Bifidobacterium longum Rosell-175 (R0175), Bifidobacterium breve Rosell-70 (R0070), Bifidobacterium bifidum Rosell-71 (R0071), and Lactococcus lactis Rosell-1058 (R1058), together with fructooligosaccharides (FOS). Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Generally healthy adults
- Aged 18 to 60 years
- Body mass index (BMI) 18.5 to 30 kg/m²
Key exclusion criteria (7 listed)
- Antibiotic use within the previous 3 months
- Chronic gastrointestinal disorders
- Chronic immune disorders
- Current probiotic or prebiotic use
- Current use of immunomodulatory medication
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 |
|---|---|---|
| Probiotic Supplementation (Lactobacillus plantarum)Also: Optibac Every Day ProbioticDaily oral administration of one capsule of a multi-strain probiotic supplement (Optibac "Every Day") for 12 weeks. Each daily dose provides 5 × 10⁹ CFU and contains Lactobacillus rhamnosus Rosell-11 (R0011), Lactobacillus acidophilus/helveticus Rosell-52 (R0052), Bifidobacterium longum Rosell-175 (R0175), Bifidobacterium breve Rosell-70 (R0070), Bifidobacterium bifidum Rosell-71 (R0071), and Lactococcus lactis Rosell-1058 (R1058), together with fructooligosaccharides (FOS). Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling. | Dietary supplement | Probiotic supplement |
| Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention.Daily oral administration of one matched placebo capsule for 12 weeks. The placebo contains potato starch in place of the probiotic bacterial mass and is matched to the active intervention in capsule shell, appearance and fill weight. Participants will take one capsule daily with water for 12 weeks, beginning the day after baseline sampling. | Dietary supplement | Vegan capsules filled with potato starch only. |
Primary outcome
Change in standardised pro-inflammatory biomarker composite
Time frame: Baseline and Week 12
Change from baseline to Week 12 in a pre-specified pro-inflammatory composite comprising IL-6, TNF-α, IL-1β, IL-8, IFN-γ and high-sensitivity C-reactive protein (hsCRP). Each biomarker will be standardised relative to its baseline distribution and the composite calculated as the mean of direction-consistent z-scores. This is a study-defined continuous composite rather than a bounded clinical scale; therefore, it has no fixed theoretical minimum or maximum. Higher composite values indicate greater systemic inflammatory activity, and a negative change from baseline indicates a reduction in inflammatory activity. The between-group change will be compared between the probiotic and placebo groups.
8 secondary outcomes
Change in plasma IL-10 concentration
Time frame: Baseline and Week 12
Change in serum cortisol concentration
Time frame: Baseline and Week 12
Change in 12-Item Short Form Health Survey Mental Component Summary score
Time frame: Baseline and Week 12
Change in 12-Item Short Form Health Survey Physical Component Summary score
Time frame: Baseline and Week 12
Change in Patient Health Questionnaire-9 total score
Time frame: Baseline and Week 12
Change in Generalized Anxiety Disorder-7 total score
Time frame: Baseline and Week 12
Change in World Health Organization-Five Well-Being Index score
Time frame: Baseline and Week 12
Change in Prospective and Retrospective Memory Questionnaire total score
Time frame: Baseline and Week 12
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 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Supplementation (Lactobacillus plantarum) in people with Healthy Participants, run by University of Reading at 1 site in United Kingdom.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 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 United Kingdom. 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?
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?
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?
Change in standardised pro-inflammatory biomarker composite (time frame: Baseline and Week 12). 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 24 Sep 2026.