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

April 24, 2019 updated by: Abbott
Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation, 454007
        • City Clinical Hospital #8
      • Irkutsk, Russian Federation, 664005
        • Railway Clinical Hospital
      • Ivanovo, Russian Federation, 153005
        • City Clinical Hospital #4
      • Izhevsk, Russian Federation, 426039
        • The First Republican Clinical Hospital of MoH UR
      • Kazan, Russian Federation, 420101
        • Interregional Clinical Diagnostic Center
      • Kemerovo, Russian Federation, 650000
        • Medical Center "Dobryj Doctor"
      • Krasnodar, Russian Federation, 350072
        • Branch Hospital AT ST. Krasnodar JSC "RZD"
      • Lyubertsy, Russian Federation, 140002
        • The Medical ON Group Lyubertsy
      • Lyubertsy, Russian Federation, 140013
        • Institute of Health
      • Lyubertsy, Russian Federation, 140013
        • SM-Clinic
      • Moscow, Russian Federation, 111123
        • Multidisciplinary Medical Clinic
      • Moscow, Russian Federation, 111123
        • Research Institute of Gastroenterology
      • Moscow, Russian Federation, 111675
        • Medical Center 'Golden Orchid'
      • Moscow, Russian Federation, 115409
        • Outpatient Dpt of City Clinical Hospital #85
      • Moscow, Russian Federation, 115522
        • Blokhin Oncology Center
      • Moscow, Russian Federation, 119021
        • 9 MDC Ministry of Defense
      • Moscow, Russian Federation, 119021
        • Medical Center on Timur Frunze Street
      • Moscow, Russian Federation, 123056
        • Medsi Clinic
      • Moscow, Russian Federation, 125319
        • CP Litfonda
      • Moscow, Russian Federation, 125368
        • Diamed Clinic
      • Moscow, Russian Federation, 125475
        • MC Larmed
      • Moscow, Russian Federation, 127220
        • Clinic 'Medic City'
      • Moscow, Russian Federation, 127473
        • MSMSU them. A. I. Evdokimov
      • Novosibirsk, Russian Federation, 630090
        • CPM LLC
      • Odintsovo, Russian Federation, 143006
        • LLC Multidisciplinary Medical Center ALTAME+
      • Orenburg, Russian Federation, 46000
        • LLC Industrial Medicine Clinic, polyclinic No1
      • Rostov-on-Don, Russian Federation, 344011
        • Treatment and Rehabilitation Center No1
      • Saint Petersburg, Russian Federation, 195279
        • Medi Com LLC (SM-clinic)
      • Saratov, Russian Federation, 410028
        • LLC 'Avesta MDC-M'
      • Stavropol, Russian Federation, 355017
        • Stavropol Regional Clinical Diagnostic Center
      • Surgut, Russian Federation, 628415
        • OKD Diagnostic Center
      • Tyumen, Russian Federation, 625026
        • Consulvative and Diagnostic Center Endos
      • Ufa, Russian Federation, 450005
        • Kuvatov RCH
      • Vladivostok, Russian Federation, 690087
        • Diamed Llc
      • Yekaterinburg, Russian Federation, 620014
        • MC Medic LLC
      • Yekaterinburg, Russian Federation, 620143
        • MC Chance LLC
      • Yekaterinburg, Russian Federation, 6220018
        • LLC "Medical Center" Doctor Plus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult subjects, male and female, aged from 18 up to 50 years with symptoms potentially indicative of IBS according to ROME IV criteria

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with IBS according to Rome IV Diagnostic Criteria by sex
Time Frame: Baseline
Baseline
Proportion of patients with IBS according to Rome IV Diagnostic Criteria by education
Time Frame: Baseline
Baseline
Proportion of patients with IBS according to Rome IV Diagnostic Criteria by region of living
Time Frame: Baseline
Baseline
Proportion of patients with IBS according to Rome IV Diagnostic Criteria by marriage status
Time Frame: Baseline
Baseline
Proportion of patients with IBS according to Rome IV Diagnostic Criteria by type of IBS
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Findings of routine examination
Time Frame: 6 months
proportion of patients with confirmed IBS by routine examination among all patients met Rome IV criteria
6 months
Comorbidity
Time Frame: Baseline
Proportion of patients with different diagnosis registered at baseline
Baseline
Routine treatment regimens
Time Frame: Baseline, 6 months
Proportion of patients received each treatment
Baseline, 6 months
Absolute score of the IBS symptoms measured by IBS-QoL scale
Time Frame: Baseline, 1, 2, 4, and 6 months
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
Time Frame: Baseline, 1, 2, 4, and 6 months
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
Time Frame: 1, 2, 4, and 6 months
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
Time Frame: 1 and 6 months
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
Time Frame: up to 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 25, 2017

Primary Completion (ACTUAL)

April 19, 2019

Study Completion (ACTUAL)

April 19, 2019

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

June 6, 2018

First Posted (ACTUAL)

June 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIDI060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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