Bacterial Infection Due to Helicobacter Pylori (H. Pylori)BLUENCT03367897
Bleeding Ulcer and Erosions Study "BLUE Study"
An observational study of Bacterial Infection Due to Helicobacter Pylori (H. Pylori) and Peptic Ulcer, run by Ostfold Hospital Trust at 2 sites in Norway.
Trial summary
A prospective study of bleeding peptic ulcers and/or erosions in the upper gastrointestinal tract - risk-medication, presence of Helicobacter pylori, treatment and outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infection Due to Helicobacter Pylori (H. Pylori), Peptic Ulcer, Bleeding Ulcer
- How many people
- 543 participants
- Where
- 2 sitesNorway
- Study dates
- Mar 2015to Jul 2019
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hematemesis and/or melena, anemia or positiv FOBT that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum. Gastroscopy must be performed within 24 hours of the findings above.
Who may be able to join
- Patients over 18 years who consent to be enrolled in the study
- Patients with hematemesis and/or melena, anemia or positiv FOBT that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum.
- Gastroscopy must be performed within 24 hours of the findings above.
Who cannot join
- Patients who do not wish to participate or are not competent to give consent.
- Patients that due to language problems or other reasons do not understand the content of the information about the study.
- Patients with erosions without hematemesis, in whom one diagnose possible bleeding source on colonoscopy.
- Patients with malignant ulcer, ulcer simplex or cameron lesions.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Akershus University Hospital
Oslo
Ostfold Hospital Trust
Sarpsborg, Østfold fylke
About this study
A prospective study of bleeding peptic ulcers and/or erosions in the upper gastrointestinal tract - risk-medication, presence of Helicobacter pylori, treatment and outcome.
Read the detailed description
Patients admitted to hospital due to hematemesis and/or melena with endoscopic finding of ulcer and/or erosion in the ventricle and/or duodenum are eligible for inclusion in the BLUE study after an informed consent has been obtained. The gastroscopy must be performed within 72 hours after admission. Epidemiological data, comorbidity and past clinical history are recorded in addition to the consumption of defined risk medication and proton-pump inhibitors (PPI) during the last 4 weeks.
The Forrest classification is used to describe an ulcer if present at endoscopy and endoscopic modalities for treatment are used according to established recommendations. Surgery or radiological intervention will be applied if needed.
An infection with H. Pylori is diagnosed by different methods including a rapid urease test, culture and serology. If one of these tests is positive, the patient will receive triple therapy. To secure successful eradication patients are tested with 13C UBT (breath test) or HP antigen stool test after 3 months and HP IgG serology after 6 months.
Registration of lowest haemoglobin (Hb) level during hospitalization and an algorithm to treatment with blood transfusion and/or high dose IV iron will be performed to evaluate alternative treatments to blood transfusions alone. Effect of treatment is evaluated at 8 weeks and 6 months. A follow-up gastroscopy and blood test is performed after 2-3 months.
- Keywords
- Helicobacter pylori, peptic ulcer, erosions, bleeding, Nsaids, Noac
- Medical subject headings
- Peptic Ulcer, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bleeding ulcer/erosions | Patients with hematemesis and/or melena, anemia or positiv FOBT that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum. Gastroscopy must be performed within 72 hours of the findings above. | |
| Peptic ulcer without bleeding | Control group for H. pylori will be patients with peptic ulcer without bleeding. These patients are systematically registered at SØ from August 2013 through the ongoing European registration study - HpEuReg study. SØ participate in this study, together with 9 other Norwegian hospitals, which is approved by REK. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk medication in peptic ulcer bleeding
Any use of NSAIDs (non-selective NSAIDs and / or COX-2 inhibitors), acetylsalicylic acid (ASA), other antiplatelet agents (non ASA antiplatelet agents), warfarin, DOAC, LMWH, H2 blockers and proton pump inhibitors during the last four weeks before the bleeding episode.
Measured: 4 weeks
Secondary outcomes (4)
PPI prophylaxis in in peptic ulcer bleeding
Any use of PPI inhibitors during the last four weeks before the bleeding episode.
Measured: 4 weeks
H. pylori infection rate
Gastric biopsies: 2 from the antrum and 2 from the corpus for culture, 1 the antrum and 1 from the corpus for rapid urease test (BIOHIT).
Blood test sampling for ELISA IgG anti-HP antibodies.
Measured: 4 weeks
In vitro H. pylori resistance to antibiotics
In vitro metronidazole susceptibility testing
Measured: 2 weeks
Eradication rate of H. pylori using OAM triple therapy
3 months: 13C UBT (breath test) or HP antigen stool test. 6 months: ELISA IgG anti-HP antibodies
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study startMar 2015
- Primary completionDec 2017
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bacterial Infection Due to Helicobacter Pylori (H. Pylori)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 543 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Jørgen Jahnsen, prof MD PhD, Principal investigator, Institute of Clinical Medicine, University of Oslo and Akershus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367897
- Sponsor's protocol ID
- 1319
- Acronym
- BLUE
- Status last verified
- Nov 2019
- First submitted
- 10 Oct 2016
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Romstad KK, Thomas O, Soberg T, Detlie TE, Ricanek P, Jahnsen ME, Lerang F, Jahnsen J. High consumption of risk medication and underutilization of proton pump inhibitors among patients with upper gastrointestinal bleeding due to peptic ulcers and erosions (BLUE study). Scand J Gastroenterol. 2026 Jan;61(1):44-52. doi: 10.1080/00365521.2025.2594780. Epub 2025 Dec 16.
PubMed 41400236Romstad KK, Detlie TE, Soberg T, Thomas O, Ricanek P, Jahnsen ME, Lerang F, Jahnsen J. Treatment and outcome of gastrointestinal bleeding due to peptic ulcers and erosions - (BLUE study). Scand J Gastroenterol. 2022 Jan;57(1):8-15. doi: 10.1080/00365521.2021.1988701. Epub 2021 Oct 18.
PubMed 34663154Romstad KK, Detlie TE, Soberg T, Ricanek P, Jahnsen ME, Lerang F, Jahnsen J. Gastrointestinal bleeding due to peptic ulcers and erosions - a prospective observational study (BLUE study). Scand J Gastroenterol. 2020 Oct;55(10):1139-1145. doi: 10.1080/00365521.2020.1819405. Epub 2020 Sep 15.
PubMed 32931710
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Ulcer and Erosions Study "BLUE Study"
- ClinicalTrials.gov ID
- NCT03367897
- Acronym / sponsor ID
- BLUE / 1319
- Keywords
- Helicobacter pylori, peptic ulcer, erosions, bleeding, Nsaids, Noac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- University Hospital, Akershus
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective study of bleeding peptic ulcers and/or erosions in the upper gastrointestinal tract - risk-medication, presence of Helicobacter pylori, treatment and outcome.
Detailed description
Patients admitted to hospital due to hematemesis and/or melena with endoscopic finding of ulcer and/or erosion in the ventricle and/or duodenum are eligible for inclusion in the BLUE study after an informed consent has been obtained. The gastroscopy must be performed within 72 hours after admission. Epidemiological data, comorbidity and past clinical history are recorded in addition to the consumption of defined risk medication and proton-pump inhibitors (PPI) during the last 4 weeks.
The Forrest classification is used to describe an ulcer if present at endoscopy and endoscopic modalities for treatment are used according to established recommendations. Surgery or radiological intervention will be applied if needed.
An infection with H. Pylori is diagnosed by different methods including a rapid urease test, culture and serology. If one of these tests is positive, the patient will receive triple therapy. To secure successful eradication patients are tested with 13C UBT (breath test) or HP antigen stool test after 3 months and HP IgG serology after 6 months.
Registration of lowest haemoglobin (Hb) level during hospitalization and an algorithm to treatment with blood transfusion and/or high dose IV iron will be performed to evaluate alternative treatments to blood transfusions alone. Effect of treatment is evaluated at 8 weeks and 6 months. A follow-up gastroscopy and blood test is performed after 2-3 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bleeding ulcer/erosions | – | –Patients with hematemesis and/or melena, anemia or positiv FOBT that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum. Gastroscopy must be performed within 72 hours of the findings above. |
| Peptic ulcer without bleeding | – | –Control group for H. pylori will be patients with peptic ulcer without bleeding. These patients are systematically registered at SØ from August 2013 through the ongoing European registration study - HpEuReg study. SØ participate in this study, together with 9 other Norwegian hospitals, which is approved by REK. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hematemesis and/or melena, anemia or positiv FOBT that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum. Gastroscopy must be performed within 24 hours of the findings above.
Key inclusion criteria (3 listed)
- Patients over 18 years who consent to be enrolled in the study
- Patients with hematemesis and/or melena, anemia or positiv FOBT that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum.
- Gastroscopy must be performed within 24 hours of the findings above.
Key exclusion criteria (4 listed)
- Patients who do not wish to participate or are not competent to give consent.
- Patients that due to language problems or other reasons do not understand the content of the information about the study.
- Patients with erosions without hematemesis, in whom one diagnose possible bleeding source on colonoscopy.
- Patients with malignant ulcer, ulcer simplex or cameron lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk medication in peptic ulcer bleeding
Time frame: 4 weeks
Any use of NSAIDs (non-selective NSAIDs and / or COX-2 inhibitors), acetylsalicylic acid (ASA), other antiplatelet agents (non ASA antiplatelet agents), warfarin, DOAC, LMWH, H2 blockers and proton pump inhibitors during the last four weeks before the bleeding episode.
4 secondary outcomes
PPI prophylaxis in in peptic ulcer bleeding
Time frame: 4 weeks
H. pylori infection rate
Time frame: 4 weeks
In vitro H. pylori resistance to antibiotics
Time frame: 2 weeks
Eradication rate of H. pylori using OAM triple therapy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Derived from this study: PubMed 41400236Romstad KK, Thomas O, Soberg T, Detlie TE, Ricanek P, Jahnsen ME, Lerang F, Jahnsen J. High consumption of risk medication and underutilization of proton pump inhibitors among patients with upper gastrointestinal bleeding due to peptic ulcers and erosions (BLUE study). Scand J Gastroenterol. 2026 Jan;61(1):44-52. doi: 10.1080/00365521.2025.2594780. Epub 2025 Dec 16.
- Derived from this study: PubMed 34663154Romstad KK, Detlie TE, Soberg T, Thomas O, Ricanek P, Jahnsen ME, Lerang F, Jahnsen J. Treatment and outcome of gastrointestinal bleeding due to peptic ulcers and erosions - (BLUE study). Scand J Gastroenterol. 2022 Jan;57(1):8-15. doi: 10.1080/00365521.2021.1988701. Epub 2021 Oct 18.
- Derived from this study: PubMed 32931710Romstad KK, Detlie TE, Soberg T, Ricanek P, Jahnsen ME, Lerang F, Jahnsen J. Gastrointestinal bleeding due to peptic ulcers and erosions - a prospective observational study (BLUE study). Scand J Gastroenterol. 2020 Oct;55(10):1139-1145. doi: 10.1080/00365521.2020.1819405. Epub 2020 Sep 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørgen Jahnsen, prof MD PhD principal investigator
Institute of Clinical Medicine, University of Oslo and Akershus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infection Due to Helicobacter Pylori (H. Pylori) and Peptic Ulcer, run by Ostfold Hospital Trust at 2 sites in Norway.
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 3 inclusion and 4 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Risk medication in peptic ulcer bleeding (time frame: 4 weeks). 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 NCT03367897, which also lists 3 linked publications.
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 18 Nov 2019.