An interventional study of Microbiome-Targeting Nutraceutical and Placebo in Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD) and Colitis, sponsored by ENBIOSIS BIOTECHNOLOGIES. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by ENBIOSIS BIOTECHNOLOGIES · Not applicable, Interventional, and Supportive care
This Phase 2b randomized, double-blind, placebo-controlled, multicenter trial will evaluate the efficacy and safety of a once-daily oral microbiome-targeted food supplement compared with matching placebo in adults with mild-to-moderate, objectively active ulcerative colitis. The supplement is food-grade and is intended for use either alongside stable standard ulcerative colitis therapy (5-aminosalicylic acid/mesalamine) or in participants not currently on any inflammatory bowel disease therapy.
Approximately 162 participants will be enrolled at university hospital centers in Turkey and randomized in a 1:1 ratio to receive either the food supplement or matching placebo for 24 weeks, in addition to their existing background therapy as defined by eligibility.
The primary objective is to determine whether the supplement increases the proportion of participants achieving composite clinical-plus-biochemical remission at Week 24. This composite endpoint requires absence of rectal bleeding, improvement in stool frequency, fecal calprotectin ≤250 micrograms/g, and no rescue therapy, prohibited treatment escalation, ulcerative colitis-related hospitalization, colectomy, or discontinuation for lack of efficacy before Week 24.
Key secondary endpoints include endoscopic improvement, deep biochemical remission, change in fecal calprotectin, change in partial Mayo score, corticosteroid-free composite remission, change in quality of life, change in C-reactive protein, time to treatment failure, and safety. Exploratory analyses will assess stool microbiome composition, eukaryotic carriage including Blastocystis, and associations between baseline microbiome features and treatment response.
Ulcerative colitis is a chronic inflammatory disease of the colonic mucosa characterized by relapsing and remitting symptoms including rectal bleeding, increased stool frequency, urgency, and impaired quality of life. Although 5-aminosalicylic acid (5-ASA, mesalamine) is the foundation of treatment for mild-to-moderate disease, a meaningful proportion of patients have persistent symptoms or ongoing objective inflammation despite optimized therapy, and many wish to defer immunosuppressive or biologic therapy. The intestinal microbiota of patients with active ulcerative colitis differ from those of healthy individuals, with depletion of short-chain fatty acid-producing taxa, reduced diversity, and altered microbial metabolism. Food-grade microbiome-targeted interventions therefore offer a non-immunosuppressive option to modify intestinal microbial ecology and inflammatory activity in this gap.
AIM-IBD is designed as a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter proof-of-concept trial. Randomization is centralized and stratified by study site and baseline 5-ASA status. Participants, investigators, site staff, outcome assessors, endoscopy readers, central laboratory personnel, microbiome and metabolomics analysts, and the primary trial statistician remain blinded to allocation until database lock, except where emergency unblinding is required for participant safety. Blinding integrity is formally assessed at Weeks 12 and 24 using participant and investigator treatment-guess questionnaires summarized with Bang's and James's blinding indices.
The Week 24 endoscopic assessment is by protocol-mandated flexible sigmoidoscopy with dual independent blinded reading and adjudication of discordant scores. Fecal calprotectin and other biomarkers are measured in a central laboratory. Stool samples for microbiome and metabolomics analyses are collected at baseline, Week 12, and Week 24 under a harmonized study procedure.
The planned sample size of 162 participants (81 per arm) provides approximately 90% power to detect a 23-percentage-point absolute difference in the Week 24 primary endpoint (placebo 12% vs active 35%), with two-sided alpha 0.05 and approximately 15% attrition. This ambitious effect size is defensible only because the trial is designed as a high-signal proof-of-concept study: the enrolled population is enriched for objectively active disease (fecal calprotectin ≥250 µg/g and rectal bleeding subscore ≥1 at screening), background therapy is held constant (stable 5-ASA at unchanged dose for ≥8 weeks, or no inflammatory bowel disease therapy), and patients with recent advanced-therapy exposure or current corticosteroids are excluded. Sensitivity analyses across a range of placebo and active response assumptions are prespecified in the Statistical Analysis Plan.
The intention-to-treat population is the primary analysis population. The primary composite endpoint is analyzed using stratified Cochran-Mantel-Haenszel methodology adjusted for randomization stratification factors. Key secondary endpoints are tested in a fixed-sequence hierarchical procedure controlling the family-wise error rate at two-sided alpha 0.05. The estimand framework follows ICH E9(R1): treatment failures (rescue therapy, prohibited escalation, ulcerative colitis-related hospitalization, colectomy, discontinuation for lack of efficacy) are handled under a composite strategy, with a supplementary treatment-policy estimand and prespecified sensitivity analyses (multiple imputation, tipping-point analysis, pattern-mixture).
An independent Data Safety Monitoring Board with a written charter oversees safety, with scheduled reviews after approximately 25%, 50%, and 75% of planned enrollment and ad hoc reviews for predefined safety signals. An independent Endpoint Adjudication Committee adjudicates ulcerative colitis-related hospitalizations, colectomies, and any deaths. Rescue therapy is permitted at any time when clinically necessary; participants requiring rescue therapy or any prohibited treatment escalation before Week 24 are classified as treatment failures for the primary endpoint and continue safety follow-up whenever feasible.
The trial is conducted in accordance with the Declaration of Helsinki and ICH-GCP E6(R3). Reporting follows the CONSORT statement, the SPIRIT protocol framework, and the STORMS reporting checklist for the microbiome workstream.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 162 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →ENBIOSIS BIOTECHNOLOGIES is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive the microbiome-targeting investigational product orally once daily for 24 weeks, in addition to either no background ulcerative colitis therapy or stable 5-aminosalicylic acid/mesalamine therapy at an unchanged dose, according to eligibility criteria. Rescue therapy or treatment escalation is permitted at any time if clinically needed.
Dietary Supplement: Microbiome-Targeting Nutraceutical
Participants assigned to this arm will receive matching placebo orally once daily for 24 weeks, in addition to either no background ulcerative colitis therapy or stable 5-aminosalicylic acid/mesalamine therapy at an unchanged dose, according to eligibility criteria. Rescue therapy or treatment escalation is permitted at any time if clinically needed.
Dietary Supplement: Placebo
The investigational product is an oral microbiome-targeting preparation administered once daily for 24 weeks. It is intended to modulate gut microbial ecology and/or microbial metabolite production in adults with mild-to-moderate ulcerative colitis. The dosage form, dose, composition class, storage conditions, and batch-release specifications are documented in the study protocol and investigational product dossier reviewed by the ethics committee and relevant regulatory authority.
The placebo is an oral matching preparation administered once daily for 24 weeks. It contains inactive excipients only and is matched to the investigational product in appearance, packaging, administration schedule, and organoleptic characteristics, including color, taste, smell, and mouthfeel, as closely as technically feasible.
Proportion of Participants Achieving Composite Clinical-Plus-Biochemical Remission at Week 24
Responder defined by all four criteria at Week 24: (1) rectal bleeding subscore = 0 on the Mayo 0-3 scale (lower = less bleeding; 0 = no blood seen); (2) stool frequency subscore ≤1 on the Mayo 0-3 scale (lower = fewer stools above the participant's normal) with at least a 1-point decrease from baseline; (3) fecal calprotectin ≤250 µg/g (lower = less mucosal inflammation), measured centrally; (4) no rescue therapy, prohibited escalation, UC-related hospitalization, colectomy, or discontinuation for lack of efficacy through Week 24. Participants not meeting any criterion, or with missing Week 24 data, are counted as non-responders (non-responder imputation). Higher proportion = greater treatment benefit. Analyzed in the intention-to-treat population using stratified Cochran-Mantel-Haenszel adjusted for randomization stratification factors, reporting absolute risk difference with Newcombe 95% CI.
Time frame: Baseline to Week 24
Proportion of Participants With Endoscopic Improvement at Week 24
Responder defined as Mayo endoscopic subscore ≤1 at Week 24 (scale 0-3; lower = less inflammation; 0 = normal, 1 = mild erythema/decreased vascular pattern, 2 = marked erythema/friability/erosions, 3 = spontaneous bleeding/ulceration). Week 24 assessment is by protocol-mandated flexible sigmoidoscopy of the most inflamed segment with standardized image/video capture, scored by two independent blinded readers; discordant scores or scores crossing the ≤1 vs \>1 threshold are adjudicated by a third blinded reader (adjudicator score = trial-of-record). Participants meeting any treatment-failure criterion before Week 24, or not undergoing the Week 24 endoscopy without documented medical exception, are counted as non-responders. A completer-only sensitivity analysis is prespecified. Higher proportion = greater treatment benefit. Analyzed in the intention-to-treat population using stratified Cochran-Mantel-Haenszel; effect estimate is absolute risk difference (Newcombe 95% CI).
Time frame: Baseline to Week 24
Proportion of Participants With Deep Biochemical Remission at Week 24
Responder defined as fecal calprotectin ≤150 µg/g at Week 24, measured centrally using a validated assay. Fecal calprotectin is a stool neutrophil-derived biomarker of intestinal inflammation: healthy adults typically \<50 µg/g; well-controlled UC \<150-250 µg/g; active disease often several hundred to several thousand µg/g. The 150 µg/g threshold is stricter than the 250 µg/g threshold used in the primary composite endpoint and corresponds to the deep biochemical remission target in STRIDE-II treat-to-target guidance. Participants meeting any treatment-failure criterion before Week 24, or with missing Week 24 calprotectin, are counted as non-responders (non-responder imputation). A completer-only sensitivity analysis is prespecified. Higher proportion = greater treatment benefit. Analyzed in the intention-to-treat population using stratified Cochran-Mantel-Haenszel adjusted for randomization stratification factors; effect estimate is absolute risk difference (Newcombe 95% CI).
Time frame: Baseline to Week 24
Change in Fecal Calprotectin From Baseline to Week 24
Continuous endpoint quantifying treatment effect on intestinal inflammation. Fecal calprotectin is a stool neutrophil-derived biomarker measured centrally using a validated assay at baseline and Week 24; healthy adults typically \<50 µg/g, well-controlled UC \<150-250 µg/g, active disease often several hundred to several thousand µg/g, with no fixed upper limit. Lower values indicate less mucosal inflammation. Values are log-transformed (natural log, after substituting half the lower limit of quantification for any below-LLOQ result), and the treatment effect is summarized as the geometric mean ratio of active vs placebo at Week 24 with 95% confidence interval, derived from a mixed model for repeated measures with treatment, visit, treatment-by-visit interaction, log baseline calprotectin, and randomization stratification factors as fixed effects. A geometric mean ratio below 1 indicates a greater reduction in fecal calprotectin in the active arm relative to placebo.
Time frame: Baseline to Week 24
Change in Fecal Calprotectin From Baseline to Week 12
Continuous endpoint quantifying early treatment effect on intestinal inflammation, prespecified as an interim biomarker readout midway through the 24-week treatment period. Fecal calprotectin is a stool neutrophil-derived biomarker measured centrally using a validated assay at baseline and Week 12; healthy adults typically \<50 µg/g, well-controlled UC \<150-250 µg/g, active disease often several hundred to several thousand µg/g. Lower values indicate less mucosal inflammation. Values are log-transformed (natural log, after substituting half the lower limit of quantification for any below-LLOQ result) and the treatment effect is summarized as the geometric mean ratio of active vs placebo at Week 12 with 95% confidence interval, derived from a mixed model for repeated measures with treatment, visit, treatment-by-visit interaction, log baseline calprotectin, and randomization stratification factors as fixed effects. A ratio below 1 indicates greater reduction in the active arm vs placebo.
Time frame: Baseline to Week 12
Proportion of Participants With Corticosteroid-Free Composite Remission at Week 24
Responder defined by meeting both: (1) the primary composite clinical-plus-biochemical remission endpoint at Week 24 (rectal bleeding subscore = 0; stool frequency subscore ≤1 with at least a 1-point decrease from baseline; fecal calprotectin ≤250 µg/g; and no rescue therapy, prohibited escalation, UC-related hospitalization, colectomy, or discontinuation for lack of efficacy through Week 24); and (2) no use of systemic or rectal corticosteroids (including budesonide-class) at any time between randomization and the Week 24 assessment. Corticosteroid exposure is captured from concomitant medication records and reconciled with rescue therapy documentation. Participants not meeting either criterion, or with missing Week 24 data, are counted as non-responders (non-responder imputation). Higher proportion = greater treatment benefit. Analyzed in the intention-to-treat population using stratified Cochran-Mantel-Haenszel; effect estimate is absolute risk difference (Newcombe 95% CI).
Time frame: Baseline to Week 24
Change in Partial Mayo Score From Baseline to Week 24
Continuous endpoint quantifying treatment effect on clinical disease activity. The partial Mayo score is the sum of three Mayo subscores - stool frequency (0-3, lower = fewer stools above the participant's normal), rectal bleeding (0-3, lower = less bleeding; 0 = no blood seen), and physician global assessment (0-3, lower = less overall disease severity in the physician's judgment) - yielding a total score from 0 to 9, with lower scores indicating less disease activity. Assessed at baseline and Week 24. Treatment effect is summarized as the least-squares mean difference between active and placebo in change from baseline to Week 24 with 95% confidence interval, derived from a mixed model for repeated measures with treatment, visit, treatment-by-visit interaction, baseline partial Mayo, and randomization stratification factors as fixed effects. A more negative change indicates greater reduction in disease activity; a between-arm difference favoring active = greater treatment benefit.
Time frame: Baseline to Week 24
Change in Inflammatory Bowel Disease Questionnaire-32 Total Score From Baseline to Week 24
Continuous endpoint quantifying treatment effect on disease-specific quality of life. The Inflammatory Bowel Disease Questionnaire-32 (IBDQ-32) is a 32-item validated patient-reported instrument covering four domains: bowel symptoms, systemic symptoms, emotional function, and social function. Each item is rated 1-7 (1 = worst, 7 = best); the total score ranges from 32 to 224, with higher scores indicating better quality of life. A change of 16 points or more is generally considered clinically meaningful. A locally validated Turkish translation is administered at baseline and Week 24. Treatment effect is summarized as the least-squares mean difference between active and placebo in change from baseline to Week 24 with 95% confidence interval, derived from a mixed model for repeated measures with treatment, visit, treatment-by-visit interaction, baseline IBDQ-32, and randomization stratification factors as fixed effects. A larger positive change in the active arm = greater benefit.
Time frame: Baseline to Week 24
Change in C-Reactive Protein From Baseline to Week 24
Continuous endpoint quantifying treatment effect on systemic inflammation. C-reactive protein (CRP) is a serum acute-phase reactant of hepatic origin, measured in mg/L by the central laboratory using a high-sensitivity assay at baseline and Week 24. Healthy adults typically have CRP \<3 mg/L; lower values indicate less systemic inflammation. Note that CRP can be normal in a sizeable subset of UC patients with active mucosal disease, particularly those with distal/left-sided disease. Values are log-transformed and the treatment effect is summarized as the geometric mean ratio of active vs placebo at Week 24 with 95% confidence interval, derived from a mixed model for repeated measures adjusting for log baseline CRP and randomization stratification factors. A ratio below 1 indicates greater reduction with active treatment.
Time frame: Baseline to week 24
Incidence of Treatment-Emergent Adverse Events
Safety endpoint summarizing the cumulative incidence and exposure-adjusted rates of adverse events over the treatment period. A treatment-emergent adverse event (TEAE) is any adverse event with onset, or worsening, on or after the first dose of study product through 4 weeks after the last dose. Reported by treatment arm: number and proportion of participants with any TEAE; any serious adverse event (SAE); any TEAE leading to study product discontinuation; and any adverse event of special interest (AESI). AESI: new-onset Clostridioides difficile infection; serious enteric or opportunistic infection; UC worsening requiring hospitalization; colectomy; hepatobiliary events; severe allergic or anaphylactic reactions; gastrointestinal perforation; death. Coded with MedDRA (version current at database lock); severity graded per CTCAE v5.0; relatedness assessed by the investigator. Higher numbers and proportions indicate more frequent events.
Time frame: From first dose through 4 weeks after the last dose (up to approximately Week 28)
Change in Stool Microbiome Composition From Baseline to Weeks 12 and 24
Exploratory endpoint characterizing treatment-associated shifts in gut microbial communities. Stool samples are collected at baseline, Week 12, and Week 24 under a harmonized SOP and processed centrally. Sequencing is by 16S rRNA gene profiling and/or shotgun metagenomics (final choice locked in the microbiome analysis plan before database lock), with negative controls, mock communities, and batch randomization. Outputs include alpha diversity (Shannon index, Faith's phylogenetic diversity; higher = more diverse), beta diversity (Aitchison and weighted/unweighted UniFrac distances; quantifying between-sample compositional difference), differential abundance of taxa using compositionally appropriate transformations (CLR/ILR) with Benjamini-Hochberg false discovery rate control at q\<0.05, and treatment-associated taxonomic and functional shifts. As an exploratory endpoint, no formal hypothesis testing within the confirmatory hierarchy is performed.
Time frame: Baseline, Week 12, and Week 24
Plan to share: Yes — De-identified individual participant data underlying the published primary and key secondary results, together with the study protocol, statistical analysis plan, analytic code, and a redacted informed consent form, will be made available on reasonable request to qualified researchers via a data-access committee. Access decisions will be made in accordance with the scope of the original participant consent and applicable Turkish data-protection law (KVKK), as well as GDPR where applicable. Microbiome and metabolomics sequence data will be deposited in a public repository (the European Nucleotide Archive, the Sequence Read Archive, or DNA Data Bank of Japan), subject to participant consent and applicable regulations. Requests will be considered for the purpose of scientific replication, secondary analyses, and individual participant data meta-analyses, consistent with the consent provided by participants. Data will be made available beginning 9 months after publication of the primary re
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Beginning 9 months and ending 36 months following publication of the primary results.
Access criteria: Requests will be reviewed by the sponsor's independent data-access committee. Data will be shared under a signed data-access agreement. Proposed analyses must be consistent with the scope of the original participant consent and applicable Turkish (KVKK) and EU (GDPR) data-protection regulations. Priority will be given to requests for scientific replication, secondary analyses, and individual participant data meta-analyses.
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Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 236 interventional studies with no phase under Colitis, Ulcerative, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's planned 14 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: start Jun 2026 → Oct 2026, primary completion May 2027 → Dec 2027 and completion Nov 2027 → Apr 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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