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

Abbott1,000 enrolled

Overview

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

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

1,000

Conditions

Irritable Bowel Syndrome

Interventions

IBSOTHER

No intervention, description of routine practice only

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (37)

Outcomes

Primary Outcomes

Proportion of patients with IBS according to Rome IV Diagnostic Criteria by sex

Time frame: Baseline

Proportion of patients with IBS according to Rome IV Diagnostic Criteria by education

Time frame: Baseline

Proportion of patients with IBS according to Rome IV Diagnostic Criteria by region of living

Time frame: Baseline

Proportion of patients with IBS according to Rome IV Diagnostic Criteria by marriage status

Time frame: Baseline

Proportion of patients with IBS according to Rome IV Diagnostic Criteria by type of IBS

Time frame: Baseline

Secondary Outcomes

Findings of routine examination

proportion of patients with confirmed IBS by routine examination among all patients met Rome IV criteria

Time frame: 6 months

Comorbidity

Proportion of patients with different diagnosis registered at baseline

Time frame: Baseline

Routine treatment regimens

Proportion of patients received each treatment

Time frame: 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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

City Clinical Hospital #8

Chelyabinsk, Russia

Railway Clinical Hospital

Irkutsk, Russia

City Clinical Hospital #4

Ivanovo, Russia

The First Republican Clinical Hospital of MoH UR

Izhevsk, Russia

Interregional Clinical Diagnostic Center

Kazan', Russia

Medical Center "Dobryj Doctor"

Kemerovo, Russia

Branch Hospital AT ST. Krasnodar JSC "RZD"

Krasnodar, Russia

The Medical ON Group Lyubertsy

Lyubertsy, Russia

Institute of Health

Lyubertsy, Russia

SM-Clinic

Lyubertsy, Russia

...and 27 more locations