Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation

NCT ID: NCT03549143

Last Updated: 2019-04-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-25

Study Completion Date

2019-04-19

Brief Summary

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Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation

Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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IBS

No intervention, description of routine practice only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female 18-50 y.o
* 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

Presence of alarm features:

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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City Clinical Hospital #8

Chelyabinsk, , Russia

Site Status

Railway Clinical Hospital

Irkutsk, , Russia

Site Status

City Clinical Hospital #4

Ivanovo, , Russia

Site Status

The First Republican Clinical Hospital of MoH UR

Izhevsk, , Russia

Site Status

Interregional Clinical Diagnostic Center

Kazan', , Russia

Site Status

Medical Center "Dobryj Doctor"

Kemerovo, , Russia

Site Status

Branch Hospital AT ST. Krasnodar JSC "RZD"

Krasnodar, , Russia

Site Status

The Medical ON Group Lyubertsy

Lyubertsy, , Russia

Site Status

Institute of Health

Lyubertsy, , Russia

Site Status

SM-Clinic

Lyubertsy, , Russia

Site Status

Multidisciplinary Medical Clinic

Moscow, , Russia

Site Status

Research Institute of gastroenterology

Moscow, , Russia

Site Status

Medical Center 'Golden Orchid'

Moscow, , Russia

Site Status

Outpatient Dpt of City Clinical Hospital #85

Moscow, , Russia

Site Status

Blokhin Oncology Center

Moscow, , Russia

Site Status

9 MDC Ministry of Defense

Moscow, , Russia

Site Status

Medical Center on Timur Frunze Street

Moscow, , Russia

Site Status

MEDSI Clinic

Moscow, , Russia

Site Status

CP Litfonda

Moscow, , Russia

Site Status

Diamed Clinic

Moscow, , Russia

Site Status

MC Larmed

Moscow, , Russia

Site Status

Clinic 'Medic City'

Moscow, , Russia

Site Status

MSMSU them. A. I. Evdokimov

Moscow, , Russia

Site Status

CPM LLC

Novosibirsk, , Russia

Site Status

LLC Multidisciplinary Medical Center ALTAME+

Odintsovo, , Russia

Site Status

LLC Industrial Medicine Clinic, polyclinic No1

Orenburg, , Russia

Site Status

Treatment and Rehabilitation Center No1

Rostov-on-Don, , Russia

Site Status

Medi Com LLC (SM-clinic)

Saint Petersburg, , Russia

Site Status

LLC 'Avesta MDC-M'

Saratov, , Russia

Site Status

Stavropol Regional Clinical Diagnostic Center

Stavropol, , Russia

Site Status

OKD Diagnostic Center

Surgut, , Russia

Site Status

Consulvative and Diagnostic Center Endos

Tyumen, , Russia

Site Status

Kuvatov RCH

Ufa, , Russia

Site Status

Diamed Llc

Vladivostok, , Russia

Site Status

MC Medic LLC

Yekaterinburg, , Russia

Site Status

MC Chance LLC

Yekaterinburg, , Russia

Site Status

LLC "Medical Center" Doctor Plus

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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EPIDI060

Identifier Type: -

Identifier Source: org_study_id

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