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

Irritable Bowel Syndrome Clinical Trial

— ROMERUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549143
• Other study ID #: EPIDI060
• Status: Completed
• Start date: December 25, 2017
• Est. completion date: April 19, 2019

Study information

• Verified date: April 2019
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• IBS
No intervention, description of routine practice only

Locations

Country	Name	City	State
Russian Federation	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	Institute of Health	Lyubertsy
Russian Federation	SM-Clinic	Lyubertsy
Russian Federation	The Medical ON Group Lyubertsy	Lyubertsy
Russian Federation	9 MDC Ministry of Defense	Moscow
Russian Federation	Blokhin Oncology Center	Moscow
Russian Federation	Clinic 'Medic City'	Moscow
Russian Federation	CP Litfonda	Moscow
Russian Federation	Diamed Clinic	Moscow
Russian Federation	MC Larmed	Moscow
Russian Federation	Medical Center 'Golden Orchid'	Moscow
Russian Federation	Medical Center on Timur Frunze Street	Moscow
Russian Federation	MEDSI Clinic	Moscow
Russian Federation	MSMSU them. A. I. Evdokimov	Moscow
Russian Federation	Multidisciplinary Medical Clinic	Moscow
Russian Federation	Outpatient Dpt of City Clinical Hospital #85	Moscow
Russian Federation	Research Institute of gastroenterology	Moscow
Russian Federation	CPM LLC	Novosibirsk
Russian Federation	LLC Multidisciplinary Medical Center ALTAME+	Odintsovo
Russian Federation	LLC Industrial Medicine Clinic, polyclinic No1	Orenburg
Russian Federation	Treatment and Rehabilitation Center No1	Rostov-on-Don
Russian Federation	Medi Com LLC (SM-clinic)	Saint Petersburg
Russian Federation	LLC 'Avesta MDC-M'	Saratov
Russian Federation	Stavropol Regional Clinical Diagnostic Center	Stavropol
Russian Federation	OKD Diagnostic Center	Surgut
Russian Federation	Consulvative and Diagnostic Center Endos	Tyumen
Russian Federation	Kuvatov RCH	Ufa
Russian Federation	Diamed Llc	Vladivostok
Russian Federation	LLC "Medical Center" Doctor Plus	Yekaterinburg
Russian Federation	MC Chance LLC	Yekaterinburg
Russian Federation	MC Medic LLC	Yekaterinburg

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with IBS according to Rome IV Diagnostic Criteria by sex		Baseline
Primary	Proportion of patients with IBS according to Rome IV Diagnostic Criteria by education		Baseline
Primary	Proportion of patients with IBS according to Rome IV Diagnostic Criteria by region of living		Baseline
Primary	Proportion of patients with IBS according to Rome IV Diagnostic Criteria by marriage status		Baseline
Primary	Proportion of patients with IBS according to Rome IV Diagnostic Criteria by type of IBS		Baseline
Secondary	Findings of routine examination	proportion of patients with confirmed IBS by routine examination among all patients met Rome IV criteria	6 months
Secondary	Comorbidity	Proportion of patients with different diagnosis registered at baseline	Baseline
Secondary	Routine treatment regimens	Proportion of patients received each treatment	Baseline, 6 months
Secondary	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).	Baseline, 1, 2, 4, and 6 months
Secondary	Changes from baseline 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). Positive change corresponds to better outcome.	Baseline, 1, 2, 4, and 6 months
Secondary	Assesment by Global Patient Assessment scale	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`.	1, 2, 4, and 6 months
Secondary	Assesment by Physician Global Assessment scale	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`.	1 and 6 months
Secondary	Adherence to treatment	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).	up to 6 months