Skip to main content
OpenTrials
Completed

NCT Number: NCT03549143

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

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IBS

Other

No intervention, description of routine practice only

Primary outcomes

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

Secondary outcomes

  1. Findings of routine examination

    Time frame: 6 months

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

  2. Comorbidity

    Time frame: Baseline

    Proportion of patients with different diagnosis registered at baseline

  3. Routine treatment regimens

    Time frame: Baseline, 6 months

    Proportion of patients received each treatment

  4. Absolute score of the IBS symptoms measured by IBS-QoL scale

    Time frame: 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).

  5. Changes from baseline of the IBS symptoms measured by IBS-QoL scale

    Time frame: 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.

  6. Assesment by Global Patient Assessment scale

    Time frame: 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'.

  7. Assesment by Physician Global Assessment scale

    Time frame: 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'.

  8. Adherence to treatment

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Acronym: ROMERUS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2018
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.