Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
- Conditions
- Irritable Bowel Syndrome
- Registration Number
- NCT03549143
- Lead Sponsor
- Abbott
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- 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)
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 marriage status 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 type of IBS Baseline
- Secondary Outcome Measures
Name Time Method Findings of routine examination 6 months proportion of patients with confirmed IBS by routine examination among all patients met Rome IV criteria
Routine treatment regimens Baseline, 6 months Proportion of patients received each treatment
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).
Comorbidity Baseline Proportion of patients with different diagnosis registered at baseline
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'.
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).
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.
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'.
Trial Locations
- Locations (37)
City Clinical Hospital #8
🇷🇺Chelyabinsk, Russian Federation
Railway Clinical Hospital
🇷🇺Irkutsk, Russian Federation
City Clinical Hospital #4
🇷🇺Ivanovo, Russian Federation
The First Republican Clinical Hospital of MoH UR
🇷🇺Izhevsk, Russian Federation
Interregional Clinical Diagnostic Center
🇷🇺Kazan, Russian Federation
Medical Center "Dobryj Doctor"
🇷🇺Kemerovo, Russian Federation
Branch Hospital AT ST. Krasnodar JSC "RZD"
🇷🇺Krasnodar, Russian Federation
The Medical ON Group Lyubertsy
🇷🇺Lyubertsy, Russian Federation
Institute of Health
🇷🇺Lyubertsy, Russian Federation
SM-Clinic
🇷🇺Lyubertsy, Russian Federation
Scroll for more (27 remaining)City Clinical Hospital #8🇷🇺Chelyabinsk, Russian Federation