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

Study Overview
=================
Brief Summary
-----------------
Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation

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.

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

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: IBS


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: IBS|No intervention, description of routine practice only|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBS; Irritable Bowel Syndrome; spasmolytics; mebeverine; Duspatalin