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The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).
This study will be a multiple-site, double-blind, placebo-controlled, parallel-group study in approximately 126 subjects with a confirmed diagnosis of CD for at least three months and have CD involving the ileum and/or colon. Following a screening period of up to 28 days, subjects will be randomly allocated into one of two treatment arms: either V565 or placebo using a 2:1 active:placebo ratio for a treatment period of 6 weeks.
Subjects will be treated with study drug as an add-on to any permitted stable medications already being taken for CD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V565 | Experimental | V565 three times a day (TID) PO for 6 weeks |
|
| Placebo | Placebo Comparator | Placebo TID PO for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V565 | Drug | Daily dosing of V565 three times a day orally for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42. | Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score < 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP. Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42. | Number of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42 Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Improvement in Endoscopic Mucosal Appearance | Subjects with a pre-treatment endoscopy Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suhail Nurbhai, MBChB MRCP | VHsquared Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Center, Inc. | Anaheim | California | 92805 | United States | ||
| West Central Gastroenterology |
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| ID | Title | Description |
|---|---|---|
| FG000 | V565 | V565 three times daily (TID) PO for 6 weeks V565: Daily dosing of V565 three times a day orally for 6 weeks |
| FG001 | Placebo | Placebo three times daily (TID) PO for 6 weeks Placebo: Daily dosing of placebo three times a day orally for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 2, 2016 | Oct 15, 2021 |
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| Placebo |
| Drug |
Daily dosing of placebo three times a day orally for 6 weeks |
|
| Day 42 |
| Day 42 |
| Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42 | The number of subjects who entered the study with an elevated CRP who had a CRP level within normal limits at Days 14 and 42. Normal levels defined as CRP less than or equal to 5mg/L | Days 14 and 42 |
| Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42 | The number of subjects who entered the study with an elevated FCP who had an FCP level within normal limits at Days 14 and 42. Normal limits of FCP defined as less than or equal to 250µg/g | Days 14 and 42 |
| Clearwater |
| Florida |
| 33762 |
| United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Galiz Research, LLC | Miami Springs | Florida | 33166 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Clinical Trials of America | Mount Airy | North Carolina | 27030 | United States |
| Klinikum Klagenfurt am Wörtersee | Klagenfurt | 9020 | Austria |
| LKH - Universitatsklinikum | Salzburg | 5020 | Austria |
| AKH - Medizinische Universität Wien | Vienna | 1090 | Austria |
| Klinikum Wels Grieskirchen | Wels | 4600 | Austria |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| London Health Science Centre | London | Ontario | N6A 5A5 | Canada |
| LHSC - Victoria Hospital | London | Ontario | N6A 5W9 | Canada |
| Vojenska nemocnice Brno | Brno | 636 00 | Czechia |
| Nemocnice Horovice | Hořovice | Czechia |
| Hepato-Gastroenterologie HK | Hradec Králové | 500 12 | Czechia |
| Poliklinika MEDICINA PLUS | Prague | 14000 | Czechia |
| Mediendo s.r.o. | Prague | 186 00 | Czechia |
| Praxiszentrum Alte Maelzerei | Regensburg | Bavaria | 93053 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitaetsklinikum Carl Gustav Carus TU | Dresden | Saxony | 01307 | Germany |
| Universitaetsklinikum Schleswig-Holstein - Campus Kiel | Kiel | Schleswig | 24105 | Germany |
| Charite Universitaetsmedizin | Berlin | 12203 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | 13353 | Germany |
| Staedisches Klinikum | Brandenburg | 14770 | Germany |
| Agaplesion Markus Krankenhaus | Frankfurt | 60431 | Germany |
| Studiengesellschaft BSF | Halle | 06108 | Germany |
| Hamburgisches Forschungsinstitut fuer CED | Hamburg | 20251 | Germany |
| Asklepios Klinik Hamburg | Hamburg | 22559 | Germany |
| Praxis fuer Magen | Heidelberg | 69121 | Germany |
| EUGASTRO GmbH | Leipzig | 04103 | Germany |
| Klinik u Poliklinik f Gastro | Leipzig | 04103 | Germany |
| DRC Gyogyszervizsgalo | Balatonfüred | 8230 | Hungary |
| Obudai Egeszsegugyi | Budapest | 1036 | Hungary |
| Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | 1062 | Hungary |
| Semmelweis Egyetem | Budapest | 1088 | Hungary |
| Endomedix Diagnosztikai | Budapest | 1139 | Hungary |
| Petz Aladar Hospital | Győr | 9024 | Hungary |
| Clinfan Szolgaltato Kft. | Szekszárd | 7100 | Hungary |
| Albert Schweitzer Ziekenhuis | Dordrecht | 3318AT | Netherlands |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| Akershus universitetssykehus HF | Lørenskog | 1478 | Norway |
| Universitetssykehuset Nord-Norge | Tromsø | 9019 | Norway |
| Polimedica Centrum Badan, Profilaktyki I Leczenia | Kielce | 25-364 | Poland |
| Indywidualna Specjalistyczna | Knurów | 44-190 | Poland |
| KO-MED Centra Kliniczne Lublin II | Lublin | 20-362 | Poland |
| SOLUMED Centrum Medyczne | Poznan | 60-529 | Poland |
| Gabinet Lekarski Bartosz Korczowski | Rzeszów | 35-302 | Poland |
| Specjalistyczna Praktyka | Sopot | 81-756 | Poland |
| KO-MED Centra Kliniczne Staszow | Staszów | 28-200 | Poland |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin | 71-270 | Poland |
| Centrum Zdrowia Matki, Dziecka i Mlodziezy | Warsaw | 00-632 | Poland |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Clinical Health Center Zvezdara | Belgrade | 11000 | Serbia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| Clinical Center Zemun | Belgrade | 11080 | Serbia |
| Clinical Center Nis | Niš | 18000 | Serbia |
| Alian s.r.o | Bardejov | 08501 | Slovakia |
| Uni nemocnica Bratislava | Bratislava | 82606 | Slovakia |
| Nemocnica A.Lena Humenne, n.o | Humenné | 06601 | Slovakia |
| Nemocnica s poliklinikou S. Kukuru Michalovce, a.s | Michalovce | 07101 | Slovakia |
| KM Management spol. s r.o. | Nitra | 949 01 | Slovakia |
| Gastromedic, s.r.o | Nové Zámky | 94002 | Slovakia |
| Gastro I, s.r.o. | Prešov | 080 01 | Slovakia |
| Svet zdravia a.s. | Rimavská Sobota | 97901 | Slovakia |
| Brovary Central District Hospital | Brovary | 07400 | Ukraine |
| Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU | Chernivtsi | 58001 | Ukraine |
| Limited Liability Company Medical Center Family Medicine Clinic | Dnipro | 49038 | Ukraine |
| Hospital for War Veterans | Kharkiv | 61019 | Ukraine |
| CHI Kharkiv City Clinical Hospital #13 | Kharkiv | 61124 | Ukraine |
| Municipal Institution of Public Health Kharkiv City Clinic #9 | Kharkiv | 61172 | Ukraine |
| CI of Healthcare Kharkiv Reg Clin Hospital | Kharkiv | 61204 | Ukraine |
| CI Ye.Ye.Karabelesh Kherson City Clinical Hosp | Kherson | 73000 | Ukraine |
| PPC Atsynus | Kirovohrad | 25006 | Ukraine |
| LLC Treatment and Diagnostic Center Adonis Plus | Kyiv | 02002 | Ukraine |
| CI of Kyiv RC Kyiv Regional Clinical Hospital | Kyiv | 04107 | Ukraine |
| Medical Centre CONSILIUM MEDICAL | Kyiv | 4050 | Ukraine |
| Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC | Lviv | 79007 | Ukraine |
| Lviv Regional Clinical Hospital | Lviv | 79010 | Ukraine |
| CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst | Sumy | 40021 | Ukraine |
| CI of SRC Sumy RCH Dept of Gastroenterology Sumy SU MI | Sumy | 40022 | Ukraine |
| Medical Center Pulse | Vinnytsia | 21001 | Ukraine |
| Private Small Enterprise Medical Center Pulse | Vinnytsia | 21001 | Ukraine |
| Vinnytsia M.I.Pyrogov Regional Clinical Hospital | Vinnytsia | 21018 | Ukraine |
| CI City Clinical Hospital #6 | Zaporizhzhia | 69035 | Ukraine |
| CI City Hospital #1 | Zaporizhzhia | 69104 | Ukraine |
| Addenbrookes Hospital | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Whipps Cross University Hospital | Leytonstone | London | E11 1NR | United Kingdom |
| St Mark's Hospital | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | Strathclyde | G51 4TF | United Kingdom |
| Neath Port Talbot Hospital | Swansea | West Glamorgan | SA12 7BX | United Kingdom |
| St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | V565 | V565 TID PO for 6 weeks V565: Daily dosing of V565 three times a day orally for 6 weeks |
| BG001 | Placebo | Placebo TID PO for 6 weeks Placebo: Daily dosing of placebo three times a day orally for 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Crohn's Disease Activity Index | Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450 | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline C-Reactive Protein (CRP) | Baseline level of C-Reactive Protein (CRP) for those subjects qualifying for the study based on CRP | Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline faecal calprotectin (FCP) measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline CRP was greater than or equal to 5mg/L | Mean | Standard Deviation | mg/L |
| |||||||||||||
| Baseline Faecal Calprotectin (FCP) | Baseline Faecal Calprotectin (FCP) level for those subjects qualifying for the study on FCP | Subjects were recruited into the study if their baseline CRP value was greater than or equal to 5mg/L OR if their baseline FCP measure was greater than or equal to 250µg/g. Data are reported for only those patients whose baseline FCP was greater than or equal to 250µg/g | Mean | Standard Deviation | µg/g |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42. | Number of responders at Day 42, defined as subjects achieving both CDAI ≥ 70-point reduction from baseline or CDAI score < 150, and a reduction of ≥ 40% from the baseline value of CRP or FCP. Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. | Intent-to-treat population. | Posted | Count of Participants | Participants | Day 42 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42. | Number of subjects achieving a ≥ 100-point reduction in CDAI score and a concomitant reduction of at least 50% in CRP or FCP at Day 42 Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. | Posted | Count of Participants | Participants | Day 42 |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Subjects With Improvement in Endoscopic Mucosal Appearance | Subjects with a pre-treatment endoscopy Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 7 (4 if disease was confined to ileum) had a post-treatment endoscopy to evaluate changes in mucosal appearance. The central reader of the endoscopies, blinded to treatment and sequence, was asked to grade if video A was better or worse than video B. Pre- and post-treatment videos were randomly assigned to A and B. The endpoint is the number of subjects whose post-treatment endoscopy was better than their pre-treatment endoscopy. | Only those subjects who had a second endoscopy are included in this analysis. | Posted | Count of Participants | Participants | Day 42 |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Subjects Achieving CRP Levels Within Normal Limits at Days 14 and 42 | The number of subjects who entered the study with an elevated CRP who had a CRP level within normal limits at Days 14 and 42. Normal levels defined as CRP less than or equal to 5mg/L | Patients were enrolled into the study based on either a baseline CRP measurement or a baseline FCP measurement. Only the subjects who entered the study based on their CRP measurement are included here. | Posted | Count of Participants | Participants | Days 14 and 42 |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Subjects Achieving FCP Levels Within Normal Limits at Day 14 and 42 | The number of subjects who entered the study with an elevated FCP who had an FCP level within normal limits at Days 14 and 42. Normal limits of FCP defined as less than or equal to 250µg/g | Patients were enrolled into the study based on either a baseline CRP measurement or a baseline FCP measurement. Only the subjects who entered the study based on their FCP measurement are included here. | Posted | Count of Participants | Participants | Days 14 and 42 |
|
|
From Day 1 (first day of study medication) to Day 56 (14 days after last dose of study medication)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V565 | V565 TID PO for 6 weeks V565: Daily dosing of V565 three times a day orally for 6 weeks | 0 | 82 | 3 | 82 | 30 | 82 |
| EG001 | Placebo | Placebo TID PO for 6 weeks Placebo: Daily dosing of placebo three times a day orally for 6 weeks | 0 | 43 | 2 | 43 | 16 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Crohns Disease | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment | Worsening of Crohn's Disease 7 days after the last dose of study medication |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | VHsquared | +44 (0)1223 837650 | info@vhsquared.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2019 | Oct 15, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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