IBS
OtherNo intervention, description of routine practice only
NCT Number: NCT03549143
Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
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Notify Me18 year–50 year
All sexes
Observational
City Clinical Hospital #8, Chelyabinsk, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Presence of alarm features:
Other:
No intervention, description of routine practice only
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: 6 months
proportion of patients with confirmed IBS by routine examination among all patients met Rome IV criteria
Time frame: Baseline
Proportion of patients with different diagnosis registered at baseline
Time frame: Baseline, 6 months
Proportion of patients received each treatment
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).
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.
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'.
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'.
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).
Abbott
Industry
Acronym: ROMERUS
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.
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