Clinical trial NCT03549143: Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
Official title: Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: IBS; Irritable Bowel Syndrome; spasmolytics; mebeverine; Duspatalin
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2018-06-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult subjects, male and female, aged from 18 up to 50 years with symptoms potentially indicative of IBS according to ROME IV criteria

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.

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.

Primary outcomes:
measure: Proportion of patients with IBS according to Rome IV Diagnostic Criteria by sex
timeFrame: Baseline
measure: Proportion of patients with IBS according to Rome IV Diagnostic Criteria by education
timeFrame: Baseline
measure: Proportion of patients with IBS according to Rome IV Diagnostic Criteria by region of living
timeFrame: Baseline
measure: Proportion of patients with IBS according to Rome IV Diagnostic Criteria by marriage status
timeFrame: Baseline
measure: Proportion of patients with IBS according to Rome IV Diagnostic Criteria by type of IBS
timeFrame: Baseline
Secondary outcomes:
measure: Findings of routine examination
timeFrame: 6 months
measure: Comorbidity
timeFrame: Baseline
measure: Routine treatment regimens
timeFrame: Baseline, 6 months
measure: Absolute score of the IBS symptoms measured by IBS-QoL scale
timeFrame: Baseline, 1, 2, 4, and 6 months
measure: Changes from baseline of the IBS symptoms measured by IBS-QoL scale
timeFrame: Baseline, 1, 2, 4, and 6 months
measure: Assesment by Global Patient Assessment scale
timeFrame: 1, 2, 4, and 6 months
measure: Assesment by Physician Global Assessment scale
timeFrame: 1 and 6 months
measure: Adherence to treatment
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: City Clinical Hospital #8
city: Irkutsk
country: Russian Federation
facility: Railway Clinical Hospital
city: Ivanovo
country: Russian Federation
facility: City Clinical Hospital #4
city: Izhevsk
country: Russian Federation
facility: The First Republican Clinical Hospital of MoH UR
city: Kazan
country: Russian Federation
facility: Interregional Clinical Diagnostic Center
city: Kemerovo
country: Russian Federation
facility: Medical Center "Dobryj Doctor"
city: Krasnodar
country: Russian Federation
facility: Branch Hospital AT ST. Krasnodar JSC "RZD"
city: Lyubertsy
country: Russian Federation
facility: The Medical ON Group Lyubertsy
city: Lyubertsy
country: Russian Federation
facility: Institute of Health
city: Lyubertsy
country: Russian Federation
facility: SM-Clinic
city: Moscow
country: Russian Federation
facility: Multidisciplinary Medical Clinic
city: Moscow
country: Russian Federation
facility: Research Institute of gastroenterology
city: Moscow
country: Russian Federation
facility: Medical Center 'Golden Orchid'
city: Moscow
country: Russian Federation
facility: Outpatient Dpt of City Clinical Hospital #85
city: Moscow
country: Russian Federation
facility: Blokhin Oncology Center
city: Moscow
country: Russian Federation
facility: 9 MDC Ministry of Defense
city: Moscow
country: Russian Federation
facility: Medical Center on Timur Frunze Street
city: Moscow
country: Russian Federation
facility: MEDSI Clinic
city: Moscow
country: Russian Federation
facility: CP Litfonda
city: Moscow
country: Russian Federation
facility: Diamed Clinic
city: Moscow
country: Russian Federation
facility: MC Larmed
city: Moscow
country: Russian Federation
facility: Clinic 'Medic City'
city: Moscow
country: Russian Federation
facility: MSMSU them. A. I. Evdokimov
city: Novosibirsk
country: Russian Federation
facility: CPM LLC
city: Odintsovo
country: Russian Federation
facility: LLC Multidisciplinary Medical Center ALTAME+
city: Orenburg
country: Russian Federation
facility: LLC Industrial Medicine Clinic, polyclinic No1
city: Rostov-on-Don
country: Russian Federation
facility: Treatment and Rehabilitation Center No1
city: Saint Petersburg
country: Russian Federation
facility: Medi Com LLC (SM-clinic)
city: Saratov
country: Russian Federation
facility: LLC 'Avesta MDC-M'
city: Stavropol
country: Russian Federation
facility: Stavropol Regional Clinical Diagnostic Center
city: Surgut
country: Russian Federation
facility: OKD Diagnostic Center
city: Tyumen
country: Russian Federation
facility: Consulvative and Diagnostic Center Endos
city: Ufa
country: Russian Federation
facility: Kuvatov RCH
city: Vladivostok
country: Russian Federation
facility: Diamed Llc
city: Yekaterinburg
country: Russian Federation
facility: MC Medic LLC
city: Yekaterinburg
country: Russian Federation
facility: MC Chance LLC
city: Yekaterinburg
country: Russian Federation
facility: LLC "Medical Center" Doctor Plus
Study officials:
References: