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Irritable Bowel SyndromeROMERUSNCT03549143

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

An observational study of Irritable Bowel Syndrome, run by Abbott at 37 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
IBS
How many people
1,000 participants
Where
37 sitesRussia
Study dates
25 Dec 2017to 19 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 13Show fewer
  • 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.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Russia37 sites

  • City Clinical Hospital #8

    Chelyabinsk, 454007

  • Railway Clinical Hospital

    Irkutsk, 664005

  • City Clinical Hospital #4

    Ivanovo, 153005

  • The First Republican Clinical Hospital of MoH UR

    Izhevsk, 426039

  • Interregional Clinical Diagnostic Center

    Kazan', 420101

  • Medical Center "Dobryj Doctor"

    Kemerovo, 650000

  • Branch Hospital AT ST. Krasnodar JSC "RZD"

    Krasnodar, 350072

  • The Medical ON Group Lyubertsy

    Lyubertsy, 140002

  • Institute of Health

    Lyubertsy, 140013

  • SM-Clinic

    Lyubertsy, 140013

  • Multidisciplinary Medical Clinic

    Moscow, 111123

  • Research Institute of gastroenterology

    Moscow, 111123

  • Medical Center 'Golden Orchid'

    Moscow, 111675

  • Outpatient Dpt of City Clinical Hospital #85

    Moscow, 115409

  • Blokhin Oncology Center

    Moscow, 115522

  • 9 MDC Ministry of Defense

    Moscow, 119021

  • Medical Center on Timur Frunze Street

    Moscow, 119021

  • MEDSI Clinic

    Moscow, 123056

  • CP Litfonda

    Moscow, 125319

  • Diamed Clinic

    Moscow, 125368

  • MC Larmed

    Moscow, 125475

  • Clinic 'Medic City'

    Moscow, 127220

  • MSMSU them. A. I. Evdokimov

    Moscow, 127473

  • CPM LLC

    Novosibirsk, 630090

  • LLC Multidisciplinary Medical Center ALTAME+

    Odintsovo, 143006

  • LLC Industrial Medicine Clinic, polyclinic No1

    Orenburg, 46000

  • Treatment and Rehabilitation Center No1

    Rostov-on-Don, 344011

  • Medi Com LLC (SM-clinic)

    Saint Petersburg, 195279

  • LLC 'Avesta MDC-M'

    Saratov, 410028

  • Stavropol Regional Clinical Diagnostic Center

    Stavropol, 355017

  • OKD Diagnostic Center

    Surgut, 628415

  • Consulvative and Diagnostic Center Endos

    Tyumen, 625026

  • Kuvatov RCH

    Ufa, 450005

  • Diamed Llc

    Vladivostok, 690087

  • MC Medic LLC

    Yekaterinburg, 620014

  • MC Chance LLC

    Yekaterinburg, 620143

  • LLC "Medical Center" Doctor Plus

    Yekaterinburg, 6220018

Other trials in Russia

About this study

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

Read the 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.

Being tested
IBS
Keywords
IBS; Irritable Bowel Syndrome; spasmolytics; mebeverine; Duspatalin
Medical subject headings
Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBSOther

    No intervention, description of routine practice only

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline

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

    Measured: Baseline

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

    Measured: Baseline

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

    Measured: Baseline

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

    Measured: Baseline

Secondary outcomes (8)

  1. Findings of routine examination

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

    Measured: 6 months

  2. Comorbidity

    Proportion of patients with different diagnosis registered at baseline

    Measured: Baseline

  3. Routine treatment regimens

    Proportion of patients received each treatment

    Measured: Baseline, 6 months

  4. 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).

    Measured: Baseline, 1, 2, 4, and 6 months

  5. 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.

    Measured: Baseline, 1, 2, 4, and 6 months

  6. 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'.

    Measured: 1, 2, 4, and 6 months

  7. 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'.

    Measured: 1 and 6 months

  8. 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).

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2018
  2. Study start25 Dec 2017
  3. Primary completion19 Apr 2019
  4. Study completion19 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03549143
Sponsor's protocol ID
EPIDI060
Acronym
ROMERUS
Status last verified
Apr 2019
First submitted
18 Dec 2017
Last updated
25 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Irritable Bowel Syndrome, run by Abbott at 37 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with IBS according to Rome IV Diagnostic Criteria by sex (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03549143.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.

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