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

Abbott

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: IBS

Study type: Observational

Funder types: Industry

Identifiers

NCT03549143

EPIDI060

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.