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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03549143
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott

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

Condition or disease Intervention/treatment
Irritable Bowel Syndrome Other: IBS

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.

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
Actual Study Start Date : December 25, 2017
Actual Primary Completion Date : April 19, 2019
Actual Study Completion Date : April 19, 2019

Intervention Details:
  • Other: IBS
    No intervention, description of routine practice only


Primary Outcome Measures :
  1. Proportion of patients with IBS according to Rome IV Diagnostic Criteria by sex [ Time Frame: Baseline ]
  2. Proportion of patients with IBS according to Rome IV Diagnostic Criteria by education [ Time Frame: Baseline ]
  3. Proportion of patients with IBS according to Rome IV Diagnostic Criteria by region of living [ Time Frame: Baseline ]
  4. Proportion of patients with IBS according to Rome IV Diagnostic Criteria by marriage status [ Time Frame: Baseline ]
  5. Proportion of patients with IBS according to Rome IV Diagnostic Criteria by type of IBS [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Findings of routine examination [ Time Frame: 6 months ]
    proportion of patients with confirmed IBS by routine examination among all patients met Rome IV criteria

  2. Comorbidity [ Time Frame: Baseline ]
    Proportion of patients with different diagnosis registered at baseline

  3. Routine treatment regimens [ Time Frame: Baseline, 6 months ]
    Proportion of patients received each treatment

  4. 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).

  5. 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.

  6. 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`.

  7. 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`.

  8. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549143


Locations
Show Show 37 study locations
Sponsors and Collaborators
Abbott
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT03549143    
Other Study ID Numbers: EPIDI060
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abbott:
IBS; Irritable Bowel Syndrome; spasmolytics; mebeverine; Duspatalin
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases