Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
NCT ID: NCT03549143
Last Updated: 2019-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2017-12-25
2019-04-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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IBS
No intervention, description of routine practice only
Eligibility Criteria
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Inclusion Criteria
* Patients suffering from Irritable bowel syndrome (abdominal pain and changes in bowel habit) as defined by Rome IV criteria and the absence of any relevant structural disease
* Patient's written authorization to provide data for the program
* Patients who are able to input him/herself data into patients' part of Electronic Data Capture (EDC)
Exclusion Criteria
* positive family history of colorectal cancer, inflammatory bowel disease, celiac disease
* rectal bleeding in the absence of documented bleeding hemorrhoids or anal fissures
* unintentional weight loss
* severe anemia (according to local laboratory reference values)
* Fever (\> 37,5 degree Celsius)
* Night symptoms appearance
Other:
* Significant and progressive change in: enlargement of the liver, spleen, lymph nodes; ascites; palpable mass in the abdomen / pelvic
* Pregnancy or lactation or the inability to use adequate contraception during the study;
* Other conditions that made the patients participation impossible (by investigator judgment)
* Previous enrollment in any other clinical study during the course of this study, including participation in a study within 30 days prior to informed consent.
* Prescribed by Health Care Professional(s) (HCP) and being currently treated or having been treated with spasmolytics within the 3 months prior to entering the study.
18 Years
50 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Locations
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City Clinical Hospital #8
Chelyabinsk, , Russia
Railway Clinical Hospital
Irkutsk, , Russia
City Clinical Hospital #4
Ivanovo, , Russia
The First Republican Clinical Hospital of MoH UR
Izhevsk, , Russia
Interregional Clinical Diagnostic Center
Kazan', , Russia
Medical Center "Dobryj Doctor"
Kemerovo, , Russia
Branch Hospital AT ST. Krasnodar JSC "RZD"
Krasnodar, , Russia
The Medical ON Group Lyubertsy
Lyubertsy, , Russia
Institute of Health
Lyubertsy, , Russia
SM-Clinic
Lyubertsy, , Russia
Multidisciplinary Medical Clinic
Moscow, , Russia
Research Institute of gastroenterology
Moscow, , Russia
Medical Center 'Golden Orchid'
Moscow, , Russia
Outpatient Dpt of City Clinical Hospital #85
Moscow, , Russia
Blokhin Oncology Center
Moscow, , Russia
9 MDC Ministry of Defense
Moscow, , Russia
Medical Center on Timur Frunze Street
Moscow, , Russia
MEDSI Clinic
Moscow, , Russia
CP Litfonda
Moscow, , Russia
Diamed Clinic
Moscow, , Russia
MC Larmed
Moscow, , Russia
Clinic 'Medic City'
Moscow, , Russia
MSMSU them. A. I. Evdokimov
Moscow, , Russia
CPM LLC
Novosibirsk, , Russia
LLC Multidisciplinary Medical Center ALTAME+
Odintsovo, , Russia
LLC Industrial Medicine Clinic, polyclinic No1
Orenburg, , Russia
Treatment and Rehabilitation Center No1
Rostov-on-Don, , Russia
Medi Com LLC (SM-clinic)
Saint Petersburg, , Russia
LLC 'Avesta MDC-M'
Saratov, , Russia
Stavropol Regional Clinical Diagnostic Center
Stavropol, , Russia
OKD Diagnostic Center
Surgut, , Russia
Consulvative and Diagnostic Center Endos
Tyumen, , Russia
Kuvatov RCH
Ufa, , Russia
Diamed Llc
Vladivostok, , Russia
MC Medic LLC
Yekaterinburg, , Russia
MC Chance LLC
Yekaterinburg, , Russia
LLC "Medical Center" Doctor Plus
Yekaterinburg, , Russia
Countries
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Other Identifiers
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EPIDI060
Identifier Type: -
Identifier Source: org_study_id
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