Irritable Bowel Syndrome
Conditions
Keywords
IBS; Irritable Bowel Syndrome; spasmolytics; mebeverine; Duspatalin
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.
Interventions
OTHERIBS
No intervention, description of routine practice only
Sponsors
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline of the IBS symptoms measured by IBS-QoL scale | 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. |
| Adherence to treatment | 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). |
| Assesment by Physician Global Assessment scale | 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'. |
| Assesment by Global Patient Assessment scale | 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'. |
| Findings of routine examination | 6 months | proportion of patients with confirmed IBS by routine examination among all patients met Rome IV criteria |
| Comorbidity | Baseline | Proportion of patients with different diagnosis registered at baseline |
| Routine treatment regimens | Baseline, 6 months | Proportion of patients received each treatment |
| Absolute score of the IBS symptoms measured by IBS-QoL scale | 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). |
Countries
Russia
Outcome results
None listed