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Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
Awareness about the disease in Russia is extremely low both among doctors and especially among patients. To date there are no data on the prevalence of the disease in Russia. This is the first study to show patient profile, main trigger factors and concomitant diseases among patients with Irritable Bowel Syndrome (IBS) in Russia. Also treatment characteristics for these patients in Russia will be measured. This study fills a lack of scientific data about prevalence of IBS and additional information.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBS | Other | No intervention, description of routine practice only |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with IBS according to Rome IV Diagnostic Criteria by sex | Baseline | |
| Proportion of patients with IBS according to Rome IV Diagnostic Criteria by education | Baseline | |
| Proportion of patients with IBS according to Rome IV Diagnostic Criteria by region of living | Baseline | |
| Proportion of patients with IBS according to Rome IV Diagnostic Criteria by marriage status | Baseline | |
| Proportion of patients with IBS according to Rome IV Diagnostic Criteria by type of IBS | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Findings of routine examination | proportion of patients with confirmed IBS by routine examination among all patients met Rome IV criteria | 6 months |
| Comorbidity | Proportion of patients with different diagnosis registered at baseline |
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Inclusion Criteria:
Exclusion Criteria:
Presence of alarm features:
Other:
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adult subjects, male and female, aged from 18 up to 50 years with symptoms potentially indicative of IBS according to ROME IV criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital #8 | Chelyabinsk | 454007 | Russia | |||
| Railway Clinical Hospital |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 25, 2020 | |
| Reset | Jul 14, 2020 |
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| Baseline |
| Routine treatment regimens | Proportion of patients received each treatment | Baseline, 6 months |
| Absolute score of the IBS symptoms measured by IBS-QoL scale | Irritable Bowel Syndrome - Quality Of Life (IBS-QOL) questionnaire contains 34 questions assessed from 1 point = "not at all" till 5 point = "a great deal". The sum of all items is used to calculate the total score. All items are negative framed with the greatest response scale equaling the worst QoL. Scores for all items are transformed to a 0 to 100 scale, ranging from 0 (worst QoL) to 100 (best QoL). | Baseline, 1, 2, 4, and 6 months |
| Changes from baseline of the IBS symptoms measured by IBS-QoL scale | Irritable Bowel Syndrome - Quality Of Life (IBS-QOL) questionnaire contains 34 questions assessed from 1 point = "not at all" till 5 point = "a great deal". The sum of all items is used to calculate the total score. All items are negative framed with the greatest response scale equaling the worst QoL. Scores for all items are transformed to a 0 to 100 scale, ranging from 0 (worst QoL) to 100 (best QoL). Positive change corresponds to better outcome. | Baseline, 1, 2, 4, and 6 months |
| Assesment by Global Patient Assessment scale | Global Patient Assessment contains one question to rate up patient's general complaints of GI-discomfort. A 5-point Likert scale is used as follow: 'symptom-free, markedly improved, slightly improved, unchanged, worse'. | 1, 2, 4, and 6 months |
| Assesment by Physician Global Assessment scale | Physician Global Assessment contains one question to rate up patient's general complaints of GI-discomfort. A 5-point Likert scale is used as follow: 'symptom-free, markedly improved, slightly improved, unchanged, worse'. | 1 and 6 months |
| Adherence to treatment | The national questionnaire of treatment compliance contains 5 questions with 4 answers each. The sum of all items is used to calculate the total score. The total score has the range from 0 (worst compliance) to 15 (best compliance). | up to 6 months |
| Irkutsk |
| 664005 |
| Russia |
| City Clinical Hospital #4 | Ivanovo | 153005 | Russia |
| The First Republican Clinical Hospital of MoH UR | Izhevsk | 426039 | Russia |
| Interregional Clinical Diagnostic Center | Kazan' | 420101 | Russia |
| Medical Center "Dobryj Doctor" | Kemerovo | 650000 | Russia |
| Branch Hospital AT ST. Krasnodar JSC "RZD" | Krasnodar | 350072 | Russia |
| The Medical ON Group Lyubertsy | Lyubertsy | 140002 | Russia |
| Institute of Health | Lyubertsy | 140013 | Russia |
| SM-Clinic | Lyubertsy | 140013 | Russia |
| Multidisciplinary Medical Clinic | Moscow | 111123 | Russia |
| Research Institute of gastroenterology | Moscow | 111123 | Russia |
| Medical Center 'Golden Orchid' | Moscow | 111675 | Russia |
| Outpatient Dpt of City Clinical Hospital #85 | Moscow | 115409 | Russia |
| Blokhin Oncology Center | Moscow | 115522 | Russia |
| 9 MDC Ministry of Defense | Moscow | 119021 | Russia |
| Medical Center on Timur Frunze Street | Moscow | 119021 | Russia |
| MEDSI Clinic | Moscow | 123056 | Russia |
| CP Litfonda | Moscow | 125319 | Russia |
| Diamed Clinic | Moscow | 125368 | Russia |
| MC Larmed | Moscow | 125475 | Russia |
| Clinic 'Medic City' | Moscow | 127220 | Russia |
| MSMSU them. A. I. Evdokimov | Moscow | 127473 | Russia |
| CPM LLC | Novosibirsk | 630090 | Russia |
| LLC Multidisciplinary Medical Center ALTAME+ | Odintsovo | 143006 | Russia |
| LLC Industrial Medicine Clinic, polyclinic No1 | Orenburg | 46000 | Russia |
| Treatment and Rehabilitation Center No1 | Rostov-on-Don | 344011 | Russia |
| Medi Com LLC (SM-clinic) | Saint Petersburg | 195279 | Russia |
| LLC 'Avesta MDC-M' | Saratov | 410028 | Russia |
| Stavropol Regional Clinical Diagnostic Center | Stavropol | 355017 | Russia |
| OKD Diagnostic Center | Surgut | 628415 | Russia |
| Consulvative and Diagnostic Center Endos | Tyumen | 625026 | Russia |
| Kuvatov RCH | Ufa | 450005 | Russia |
| Diamed Llc | Vladivostok | 690087 | Russia |
| MC Medic LLC | Yekaterinburg | 620014 | Russia |
| MC Chance LLC | Yekaterinburg | 620143 | Russia |
| LLC "Medical Center" Doctor Plus | Yekaterinburg | 6220018 | Russia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 25, 2020 | Jul 14, 2020 |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D053560 | Ichthyosis Bullosa of Siemens |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007057 | Ichthyosis |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D007232 | Infant, Newborn, Diseases |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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