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Clinical trials landscape

TL;DR — ClinicalTrials.gov returned 1,180 registered studies for irritable bowel syndrome on 2026-10-28 (query.cond = "irritable bowel syndrome"). The complete snapshot contains 705 completed, 103 recruiting, 57 not yet recruiting, 20 active but not recruiting, 63 terminated, 25 withdrawn, 14 enrolling by invitation, 4 suspended, 188 unknown-status and 1 no-longer-available record; these ten statuses sum to 1,180. 106 carry a phase 3 tag, 80 a phase 4 tag, 44 a phase 1 tag and 598 a not-applicable phase tag; phase tags are not mutually exclusive. Condition-plus-intervention queries returned 134 probiotic, 99 FODMAP, 51 cognitive behavioural therapy, 37 faecal microbiota transplantation, 27 rifaximin and 27 linaclotide records. Twenty-one phase 3 records have a start date on or after 2021-01-01. Camlipixant (NCT07519395) and both brenipatide studies (NCT07545759, NCT07545772) remain recruiting without registry results. The metabolite-selected probiotic pilot (NCT07872514) is unchanged. A new Calgary SIMBA-capsule plus open-label rifaximin protocol (NCT07882953) uses Rome V subtype eligibility. Rimegepant (NCT06221111) has posted results: the primary abdominal-pain analysis was negative. A new sham-controlled crossover protocol of transcutaneous auricular vagus nerve stimulation (NCT07890948, n=40) was first posted 2026-10-23. The completed Czech multi-donor FMT trial (NCT04899869) has no registry results but has now posted a null preprint. Prior NCT identifiers were re-fetched individually. This refresh verifies registry fields, not the efficacy of unpublished interventions.

The registry at a glance (2026-10-28)

Slice Count
All registered IBS studies 1,180
Completed 705
Recruiting 103
Not yet recruiting 57
Active, not recruiting 20
Terminated 63
Withdrawn 25
Enrolling by invitation 14
Suspended 4
Unknown status 188
No longer available 1
Phase 1 44
Phase 2 177
Phase 3 106
Phase 4 80
Phase not applicable 598
Intervention term Studies
Probiotic 134
FODMAP 99
Cognitive behavioural therapy 51
Faecal microbiota transplantation 37
Rifaximin 27
Linaclotide 27
Hypnotherapy 22
Acupuncture 18
Vagus nerve stimulation 12
Tenapanor 9
Amitriptyline 4
Ebastine 4

The ten status categories in this complete snapshot sum to 1,180. The previously unlisted NO_LONGER_AVAILABLE category accounts for one record; nine-category status tables omit it. Phase tags are not a partition: a study can carry more than one phase (NCT05519683 is tagged both phase 2 and phase 3). The shape of the intervention table is the finding. Four amitriptyline studies exist in the registry for a drug that the largest IBS trial ever run showed to be effective in primary care (gut-brain-neuromodulators); 134 probiotic studies exist for a class whose GRADE certainty is low to very low across almost every analysis (microbiome).

Novel mechanisms in industry development

NCT Agent / mechanism Phase n Status Sponsor Start
NCT07519395 Camlipixant (P2X3 receptor antagonist) vs placebo, abdominal symptoms in IBS-D and IBS-M 2 420 Recruiting GlaxoSmithKline 2026-04-08
NCT07545759 Brenipatide (LY3537031) vs placebo, subcutaneous, IBS-D 2 531 Recruiting Eli Lilly 2026-05-06
NCT07545772 Brenipatide (LY3537031) vs placebo, subcutaneous, IBS-C 2 342 Recruiting Eli Lilly 2026-04-29
NCT06206265 Psilocybin plus psychotherapy, open-label delayed-treatment design 2 14 Active, not recruiting TRYP Therapeutics 2024-01-17
NCT06727422 Rifaximin + N-acetylcysteine (two dose combinations) vs placebo in IBS-D 2 225 Recruiting Mark Pimentel, MD 2026-02-04
NCT06247046 Live SK08 powder (live biotherapeutic) vs placebo in IBS-D 3 1,298 Recruiting Guangzhou Zhiyi Biotechnology 2024-03-16
NCT07168434 Saccharomyces boulardii CNCM I-745 vs placebo 3 406 Recruiting Biocodex 2025-10-22
NCT05815602 Ebastine vs mebeverine (H1-antagonist vs antispasmodic) 3 200 Active, not recruiting (last update 2026-09-11; no results posted) Guy Boeckxstaens 2023-03-30
NCT07114055 Ebastine vs placebo in IBS-D 3 60 Recruiting Md. Hazrat Ali 2025-08-15
NCT06221111 Rimegepant (CGRP antagonist) vs placebo for IBS pain 2 39 enrolled; 24 analysed Completed; results posted (last update 2026-10-15) Mayo Clinic 2024-06-06
NCT07522255 Rifaximin in bloating-predominant functional bowel disorders 3 78 Not yet recruiting (estimated start moved to 2026-12 in the 2026-10-27 update) Mahidol University 2026-12 (est.)

P2X3 antagonism is an afferent-nerve mechanism consistent with the visceral-hypersensitivity model (brain-gut-axis-and-visceral-hypersensitivity). The registry does not state brenipatide's molecular target, so no mechanism is inferred here. The ebastine programme is the therapeutic test of the mast-cell/histamine hypothesis and now includes an active-comparator phase 3 against mebeverine (NCT05815602) — worth watching given that mebeverine itself has a null pooled estimate (antispasmodics-and-peppermint).

Rimegepant 75 mg every other day for 4 weeks in non-constipation IBS pain did not beat placebo on the primary endpoint. Among 24 randomised participants (12 per arm; the registry enrolment field is 39), median change in 100-mm VAS abdominal pain at day 28 was −12 (IQR −16.9 to −6.4) versus −22.6 (−30.3 to −8.1) with placebo (ANCOVA p=0.41). Bowel-movement frequency and rectal compliance secondary analyses had p=0.043 and p=0.041; colonic transit, IBS-QOL and adverse-event counts (3/12 vs 3/12) did not favour the drug. No deaths or serious adverse events were reported in the results module (NCT06221111, ClinicalTrials.gov results API, retrieved 2026-10-21). This is a small negative CGRP pilot, not a registration programme.

The brenipatide records were updated on 2026-10-08; both retain their recruiting status and planned enrolments (531 IBS-D; 342 IBS-C), with no posted results. Camlipixant remains recruiting (last update 2026-09-22). These are record updates, not treatment readouts.

Paediatric label extensions of approved drugs

NCT Drug Phase n Status Sponsor
NCT04880876 Eluxadoline 25/100 mg in paediatric IBS-D 3 124 Enrolling by invitation AbbVie
NCT05643534 Tenapanor in IBS-C, ages 12 to <18 3 180 Completed (last update 2026-09-22; no results posted) Ardelyx
NCT05905926 Tenapanor safety, ages 6 to <18, IBS-C 3 150 Enrolling by invitation Ardelyx
NCT06553547 Tenapanor dose-ranging, ages 6 to <12, IBS-C 2 72 Completed Ardelyx
NCT06639984 Psyllium in paediatric IBS 2 110 Recruiting Bruno Chumpitazi, MD

This knowledge base is adult-scoped; these are listed because they represent a substantial share of current commercial phase 3 activity in IBS.

Microbiome interventions

NCT Study Phase n Status Sponsor
NCT07872514 Metabolite-selected probiotic vs placebo; randomized masked n-of-1 crossovers over eight weeks, first posted 2026-10-13 NA 30 planned Enrolling by invitation; no results McMaster University
NCT04691544 Donor vs autologous FMT for IBS (REFIT2) 3 450 Active, not recruiting on the registry (last update 2024-02-26; no results posted). The trial is published and negative (Johnsen 2026, PMID 42785338) University Hospital of North Norway
NCT06433180 FMT capsules vs sham in severe IBS 3 150 Not yet recruiting AP-HP, Paris
NCT04014413 Multicondition FMT safety/efficacy platform; 450 total enrollment, IBS subgroup size not stated NA 450 total Recruiting Chinese University of Hong Kong
NCT05803980 FMT for non-constipated IBS NA 35 Recruiting Policlinico Gemelli, Rome
NCT06948461 Freeze-dried oral FMT in IBS-D or recurrent C. difficile 2 63 Not yet recruiting PharmaPlanter Technologies
NCT05633706 SIMBA fluid-biopsy capsule for small-intestinal dysbiosis; 300 total across seven conditions and healthy controls NA 300 total Active, not recruiting (last update 2026-09-30; no results posted) Nimble Science
NCT07882953 SIMBA capsule plus open-label rifaximin in IBS-C, IBS-D and IBS-M (SIMPACT); Rome V subtype eligibility; first posted 2026-10-20 1 180 planned Not yet recruiting; no results University of Calgary
NCT04899869 MISCEAT: multi-donor mixed-microbiota FMT vs autoclaved placebo FMT, three-arm double-blind crossover, IBS-D/IBS-M NA 61 actual Completed 2024-03-27; no registry results. Null on IBS-SSS in a Research Square preprint (Cinek 2026, doi:10.21203/rs.3.rs-11289849/v1, not peer reviewed); see microbiome Thomayer University Hospital, Prague
NCT07517029 Gut microbiome in post-infectious IBS Obs. 315 Recruiting Policlinico Gemelli, Rome
NCT06801184 Intestinal microbiota in IBS-C with methane production Obs. 40 Recruiting Hospices Civils de Lyon

The Norwegian donor-vs-autologous phase 3 (NCT04691544, n=450) has now reported. REFIT2 found no benefit of a once-only healthy-donor rectal enema over autologous faeces on a ≥75-point IBS-SSS reduction at 90 days: 40% versus 38%, absolute difference 1.9 percentage points (95% CI −8.1 to 12.0; p=0.76), in 448 participants who received the allocated treatment (Johnsen 2026, PMID 42785338). The registry record had still not caught up on 2026-10-14 (last update 2024-02-26; active, not recruiting; no results). The result does not explain the positive single-donor gastroscopic trial on microbiome, and the abstract does not report a ≥50-point analysis. Full note: Johnsen 2026 — REFIT2.

Diet and behavioural interventions

NCT Study n Status Sponsor
NCT04270487 DOMINO: smartphone FODMAP-lowering diet app vs otilonium bromide in primary care 472 Completed (phase 4) KU Leuven
NCT03687814 Low FODMAP + PEG 3350 vs sham diet + PEG 3350 in IBS-C 78 Recruiting University of Michigan
NCT05120752 Low FODMAP in the absence of lactose malabsorption 60 Recruiting UZ Brussel
NCT04974593 Predictive value of lactose breath testing for lactose-free-diet response 90 Recruiting UZ Brussel
NCT06912828 GWAS for genetic predictors of dietary-intervention success (Med-LFD) 100 Recruiting Attikon Hospital
NCT05721742 Virtual dietitian consults within an electronic IBS pathway 71 Completed (last update 2026-09-09; no results posted) Nova Scotia Health Authority
NCT04133519 Regulora digital gut-directed hypnotherapy vs digital muscle relaxation 378 Completed metaMe Health
NCT03899779 Face-to-face vs online hypnotherapy vs online psychoeducation 282 Completed Maastricht UMC
NCT06297785 Online gut-directed hypnotherapy 50 Completed Sahlgrenska
NCT06866106 WISH 2.0: positive psychology vs educational intervention 50 Recruiting Massachusetts General Hospital
NCT01529567 CBT with vs without exposure therapy 311 Completed Karolinska Institutet
NCT00934973 MIBS: mebeverine, methylcellulose, placebo, CBT website 135 Completed (phase 4) Hazel Everitt
(ACTIB and ATLANTIS) Registered on the ISRCTN registry (ISRCTN44427879 and ISRCTN48075063), not on ClinicalTrials.gov — see psychological-therapy and gut-brain-neuromodulators — — —

DOMINO deserves its result stated: 459 primary-care IBS patients randomised to 8 weeks of otilonium bromide 40 mg three times daily or a smartphone FODMAP-lowering diet app, followed for 24 weeks. Responder rate (IBS-SSS improvement ≥50) at 8 weeks was 71% (155/218) with diet versus 61% (133/217) with otilonium (p=0.03), and 77% vs 62% (p=0.004) in the Rome IV-positive subgroup. Adherence was 94% with diet versus 73% with the drug (p<0.001). The advantage was already present at 4 weeks (62% vs 51%, p=0.02). Predictors of response were female sex for diet (OR 2.08, p=0.04) and PHQ15 for otilonium (OR 1.10, p=0.02). The authors' conclusion: "A FODMAP-lowering diet should be considered the first-line treatment for IBS in primary care" (Carbone 2022, PMID 35483886). Post-hoc analyses have examined subtype effects (Di Rosa 2024, PMID 39086991), inflammatory biomarkers (Tack 2025, PMID 41436948) and eosinophil-driven immune activation (Routhiaux 2026, PMID 41670574).

Neuromodulation devices

NCT / publication Intervention n Status
NCT06090110 Vagal nerve stimulation vs sham 166 Recruiting (Maastricht UMC)
NCT05519683 Home transcutaneous electrical acustimulation vs escitalopram 160 Recruiting (University of Michigan), phase 2/3
NCT07425145 Transcutaneous electrical acustimulation for IBS-D, multicentre 200 Not yet recruiting
Liu 2024, PMID 39689011 Transcutaneous auricular vagus nerve stimulation in IBS-C, single-centre single-blind RCT — Published
Veldman 2025, PMID 39867596 Systematic review of vagus nerve stimulation across GI disorders — Published
NCT07798180 Transauricular neurostimulation for abdominal pain in DGBI (paediatric) 30 Recruiting
NCT07890948 Transcutaneous auricular VNS vs sham, single-blind crossover, Rome IV adults 18–60; primary IBS-SSS; first posted 2026-10-23 40 Not yet recruiting (Hoag Memorial Hospital Presbyterian)

Vagal and acustimulation approaches are the fastest-growing device category, at 11 registered studies. The Michigan trial comparing home acustimulation directly against escitalopram (NCT05519683) is unusual in using an active drug comparator.

What the landscape is missing

  1. Head-to-head licensed-drug comparisons. The 2026-09-02 registry review found no trial comparing two drugs both licensed specifically for IBS; that qualitative scan was not repeated on 2026-09-30. The ebastine-versus-mebeverine trial is a comparison of an investigational repurposing candidate with an antispasmodic (NCT05815602) and is now active, not recruiting, with no results posted. Licensed-drug rankings therefore remain indirect (constipation-predominant-pharmacotherapy, diarrhoea-predominant-pharmacotherapy).
  2. Neuromodulator versus behavioural therapy in primary care. Targeted searches on 2026-09-02 retrieved no amitriptyline-versus-CBT trial, and a date-restricted PubMed search from 2026-09-02 through 2026-09-30 returned none (OPEN-QUESTIONS.md).
  3. Criteria-stratified trials. Searches on 2026-09-02 retrieved no study stratifying treatment response by Rome III/IV/V status, and date-restricted PubMed searches through 2026-09-30, 2026-10-14 and 2026-10-21 returned none. NCT07882953 uses Rome V as an eligibility rule; that is not a stratified treatment-effect analysis (diagnosis-and-rome-criteria).
  4. Prevention of post-infectious IBS. A validated risk score exists (Thabane 2009, PMID 19568228). Searches on 2026-09-02 retrieved no prevention trial using it, and a date-restricted PubMed search through 2026-09-30 returned no prevention trial (post-infectious-ibs).
  5. Open-label placebo as an intervention arm in a pragmatic trial. A search on 2026-09-02 retrieved no such pragmatic trial, despite three explanatory randomised studies, and a date-restricted PubMed search through 2026-09-30 returned none (placebo-response-and-trial-design).
  6. Long-term controlled follow-up. Most drug trials stop at 12–26 weeks in a lifelong relapsing condition; uncontrolled 52-week safety or observational extensions exist for some agents.
  7. Work and social function as primary endpoints. Targeted PubMed and registry searches on 2026-09-02 found work-productivity analyses as secondary/economic outcomes, but no IBS treatment trial with work or social function as the primary endpoint, despite 81.8% overall work impairment (quality-of-life-and-stigma).

Registry hygiene notes

  • 188 of 1,180 studies (15.9%) carry "unknown" status, meaning the record has passed its expected completion date without an update. Any statement about "what is currently being tested" based on registry status alone will overcount active work.
  • 63 terminated and 25 withdrawn studies are recorded; reasons are not systematically comparable.
  • Between 2026-09-03 and 2026-09-30 the API returned 23 studies with a last-update post date in that window and one newly posted record (NCT07829666, a completed three-arm diet comparison, n=90, Acibadem University, first posted 2026-09-21, no results). No IBS study posted results for the first time in that window. Unpublished registry updates are not entered as results on this page.
  • Sweep of 2026-09-30 through 2026-10-14. Thirteen condition-query records had last-update dates in that inclusive window; five were first posted in it. None of the 1,177 returned records had a results-first-post date in the window.
  • Sweep of 2026-10-14 through 2026-10-21. Seven condition-query records have last-update dates in this inclusive window; two were first posted in it (NCT07880327 paediatric psyllium, n=70, not yet recruiting; NCT07882953 SIMBA-plus-rifaximin, n=180, not yet recruiting). None of the 1,179 returned records has a results-first-post date in the window. Rimegepant (NCT06221111) was last updated 2026-10-15 with results that were first posted 2026-05-22; those numbers are now on this page. Camlipixant, both brenipatide studies, REFIT2, ebastine–mebeverine, paediatric tenapanor, the virtual dietitian and NCT07872514 are unchanged in status and still without new results. This does not reconstruct intermediate historical changes.
  • Current sweep (2026-10-21 through 2026-10-28). Six condition-query records have last-update dates in this inclusive window. One was first posted in it (NCT07890948, taVNS crossover, n=40). None of the 1,180 returned records has a results-first-post date in the window. All 67 NCT identifiers cited in this condition were re-fetched individually; only NCT07522255 changed (estimated start 2026-12). Camlipixant, both brenipatide studies, REFIT2 (NCT04691544, last update still 2024-02-26), ebastine–mebeverine, paediatric tenapanor and NCT07872514 are unchanged and have no new results. The ISRCTN XML API query for lastEdited in 2026-10-21–2026-10-28 returned totalCount="0".
  • Non-US search (2026-10-14 through 2026-10-21 sweep). ISRCTN XML API query condition:"irritable bowel syndrome" AND lastEdited GE 2026-10-14T00:00:00 AND lastEdited LE 2026-10-21T23:59:59 returned totalCount="2": ISRCTN15681288 (EBX-102-02 phase 2b, IBS-C, target 300) and ISRCTN65517362 (EBX-102-02 phase 2, IBS-C and IBS-D, target 120). Neither has a matching ClinicalTrials.gov record in a condition-plus-intervention query for EBX-102. WHO ICTRP's portal returned HTTP 200 but is JavaScript-driven, so it was not searched as a database. ANZCTR's search page returned 200; ChiCTR and CTRI homepages returned 200. Those are reachability checks, not structured registry searches. CENTRAL was not searched.
  • Two of the most influential recent trials in this knowledge base — ATLANTIS and ACTIB — are registered on the ISRCTN registry (ISRCTN48075063 and ISRCTN44427879), not on ClinicalTrials.gov, so a ClinicalTrials.gov-only survey systematically under-represents UK publicly funded trials.

Open questions

  • Will camlipixant (NCT07519395) validate P2X3 antagonism as an IBS mechanism, and if it fails, what does that say about the visceral-hypersensitivity model?
  • REFIT2 is published and negative on a ≥75-point endpoint (Johnsen 2026, PMID 42785338), while NCT04691544 still has no results posted. What, if anything, do the unpublished secondary and ≥50-point analyses show, and why was the single-donor gastroscopic trial so different?
  • Does ebastine beat placebo — and mebeverine — in adequately powered trials? The mebeverine comparison (NCT05815602) is now active, not recruiting, with no results posted; the placebo comparison (NCT07114055) was still recruiting on 2026-10-14.
  • Why are there 134 probiotic studies and 4 amitriptyline studies for a condition where the tricyclic evidence is stronger?
  • NCT07882953 now uses Rome V subtype eligibility for an open-label SIMBA-plus-rifaximin protocol. Will any trial stratify a treatment effect by Rome III/IV/V, and will that change measured effect sizes (Staller 2026, PMID 42392123)?
  • Rimegepant missed its primary pain endpoint in 24 analysed participants (NCT06221111). Does that close CGRP as an IBS target, or only this dose, duration and sample?
  • Should DOMINO's conclusion — diet first-line in primary care (Carbone 2022, PMID 35483886) — be tested against ATLANTIS's amitriptyline in the same setting?

References

  1. Carbone F, et al. Diet or medication in primary care patients with IBS: the DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute. Gut. 2022;71(11):2226-2232. PMID 35483886 (NCT04270487)
  2. Di Rosa C, et al. DOMINO trial post hoc analysis: evaluation of the diet effects on symptoms in IBS subtypes. Therap Adv Gastroenterol. 2024;17:17562848241255296. PMID 39086991
  3. Tack C, et al. A study on the utility of inflammatory biomarkers in primary care irritable bowel syndrome: a sub analysis of the DOMINO randomized trial. BMC Gastroenterol. 2025;26:69. PMID 41436948
  4. Routhiaux K, et al. Involvement of Eosinophil-Driven Intestinal Immune Activation in Different Irritable Bowel Syndrome Subtypes and in the Response to a FODMAP Lowering Diet: A Post Hoc Analysis of the Randomized Controlled DOMINO Trial. Gastroenterology. 2026;170(4):818-820. PMID 41670574
  5. Liu J, et al. Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Constipation-Predominant Irritable Bowel Syndrome. Am J Gastroenterol. 2024;120(9):2139-2153. PMID 39689011
  6. Veldman F, et al. Efficacy of vagus nerve stimulation in gastrointestinal disorders: a systematic review. Gastroenterol Rep (Oxf). 2025;13:goaf009. PMID 39867596
  7. Berry SK, Berry R, Recker D, Botbyl J, Pun L, Chey WD. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023;21(12):3152-3159.e2. PMID 37391055 (NCT04133519)
  8. Ford AC, et al. Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS). Lancet. 2023;402(10414):1773-1785. PMID 37858323 (ISRCTN48075063)
  9. Everitt HA, et al. Assessing telephone-delivered cognitive-behavioural therapy (CBT) and web-delivered CBT versus treatment as usual in irritable bowel syndrome (ACTIB). Gut. 2019;68(9):1613-1623. PMID 30971419 (ISRCTN44427879)
  10. Nybacka S, et al. A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARIBS). Lancet Gastroenterol Hepatol. 2024;9(6):507-520. PMID 38643782 (NCT02970591)
  11. Thabane M, Simunovic M, Akhtar-Danesh N, Marshall JK. Development and validation of a risk score for post-infectious irritable bowel syndrome. Am J Gastroenterol. 2009;104(9):2267-74. PMID 19568228
  12. Staller K, et al. The Rome V criteria for the diagnosis of irritable bowel syndrome in secondary care: a diagnostic accuracy study. Lancet Gastroenterol Hepatol. 2026;11(9):812-820. PMID 42392123
  13. Johnsen PH, et al. Faecal microbiota transplantation in irritable bowel syndrome (REFIT2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2026. PMID 42785338 (NCT04691544)
  14. Cinek O, et al. Faecal microbiota transplantation in patients with irritable bowel syndrome modulates the gut microbiome but lacks clinical effects: results of a randomised, double-blind crossover clinical trial. Research Square. 2026 Oct 23 (preprint, not peer reviewed). doi:10.21203/rs.3.rs-11289849/v1

Trial registrations cited above (retrieved live from the ClinicalTrials.gov v2 API, 2026-10-28): NCT07519395, NCT07545759, NCT07545772, NCT06206265, NCT06727422, NCT06247046, NCT07168434, NCT05815602, NCT07114055, NCT06221111, NCT07522255, NCT04880876, NCT05643534, NCT05905926, NCT06553547, NCT06639984, NCT04691544, NCT06433180, NCT04014413, NCT05803980, NCT06948461, NCT05633706, NCT07882953, NCT07517029, NCT06801184, NCT04270487, NCT03687814, NCT05120752, NCT04974593, NCT06912828, NCT05721742, NCT04133519, NCT03899779, NCT06297785, NCT06866106, NCT01529567, NCT00934973, NCT06090110, NCT05519683, NCT07425145, NCT07798180, NCT02970591, NCT07829666, NCT07872514, NCT04899869, NCT07890948. Non-US last-edited records: ISRCTN15681288, ISRCTN65517362.