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Trial registered on ANZCTR


Registration number
ACTRN12607000287437
Ethics application status
Not yet submitted
Date submitted
29/05/2007
Date registered
31/05/2007
Date last updated
31/05/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, controlled trial of Helicobacter pylori (H.pylori) eradication therapy plus oral iron therapy versus oral iron therapy alone in patients with iron deficiency of obscure origin
Scientific title
An evaluation of the effect of Nexium Hp7 in patients with Helicobacter pylori and iron deficiency of obscure origin on the chance of persistent or recurrent iron deficiency after a course of oral iron therpay.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency with no cause found on gastroscopy, colonoscopy and duodenal biopsy 1828 0
Condition category
Condition code
Blood 1920 1920 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nexium Hp7 contains three different drugs: esomeprazole 20mg tablets (labelled E), amoxycillin trihydrate 500mg tablets (labelled A) and clarithromycin 500mg tablets (labelled C). Nexium Hp7 therapy comprises one tablet of E, two tablets of A and one tablet of C taken by mouth twice daily for 1 week. This will be prescribed to half of those who are H pylori positive; All subjects will receive oral iron therapy (2 months of FerroGrad, 1 tablet daily by mouth), beginning at the same time as Nexium Hp7 therapy in those assigned to receive Nexium Hp7, as standard medical practise
Intervention code [1] 1786 0
Treatment: Drugs
Comparator / control treatment
Control groups (the remaining half of those who are H pylori positive and those who are H pylori negative) will receive no Nexium Hp7.
Control group
Active

Outcomes
Primary outcome [1] 2734 0
Persistent or recurrent iron deficiency over 8 months of follow-up
Timepoint [1] 2734 0
Haemoglobin and ferritin levels will be measured in venous blood taken at the end of the two months of oral iron therapy, and every two months for 6 further months or until the primary outcome is reached.
Secondary outcome [1] 4609 0
Rate of fall of blood ferritin level measured by venous blood samples
Timepoint [1] 4609 0
Taken at the end of the two months of oral iron therapy, and every two months for 6 further months.

Eligibility
Key inclusion criteria
Iron-deficiencyWilling to participate in studyAble to comply with requirements of study, including duration and blood testing.
Minimum age
18 Years
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consentEndoscopies showing any of the following pathologies: Colonic carcinoma Gastric carcinoma Benign gastric or duodenal ulceration Multiple (>1) gastric erosions or haemorrhagic gastritis Multiple small, or at least one large (spider-like), angiodysplasia Gastric antral vascular ectasia Ampullary carcinoma Severe (grade 3 or higher) oesophagitis Previous gastrectomy Dieulafoy’s lesionHistory of, or duodenal biopsy showing, coeliac diseaseRequirement for blood transfusionCurrent overt gastrointestinal bleedingHistory of coagulation or platelet disorderHistory of receiving previous H.pylori eradication therapyAlready received iron therapy for more than 2 weeks for current episode of iron-deficiencyUnable to tolerate oral iron therapyPrevious drug reaction or allergic to any study drugPrevious drug reaction or allergic to any ingredient contained within Nexium Hp7Previous drug reaction or allergic to any proton pump inhibitorPrevious drug reaction or allergic to any penicillin, macrolide or cephalosporin antibioticCurrently taking cisapride, pimozide, ergotamine or dihydroergotamineCurrently taking anticoagulants (warfarin, heparin)History of taking non-steroidal anti-inflammatory drugs or clopidogrel within previous 3 monthsSevere liver diseaseElevated creatinine level > 120micromol/l or estimated glomerular filtration rate < 60ml/minKnown malignancy except localised skin cancerAny haemoglobinopathy or other haematological disorder apart from iron-deficiency anaemiaBlood donor at any time within previous six months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2066 0
Charities/Societies/Foundations
Name [1] 2066 0
Department of Gastroenterology, St Vincent's Health (Melbourne) Ltd
Country [1] 2066 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
St Vincent's Health (Melbourne) Ltd
Address
Country
Australia
Secondary sponsor category [1] 1871 0
None
Name [1] 1871 0
None
Address [1] 1871 0
Country [1] 1871 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3838 0
St Vincent's Health (Melbourne) Ltd
Ethics committee address [1] 3838 0
Ethics committee country [1] 3838 0
Australia
Date submitted for ethics approval [1] 3838 0
Approval date [1] 3838 0
Ethics approval number [1] 3838 0

Summary
Brief summary
A low blood haemoglobin level, known as anaemia, is a common medical condition and is frequently caused by a deficiency in stored iron. Despite close scrutiny of an individual’s history, diet, ability to absorb iron, and both stomach and colon by endoscopy (flexible telescopic examination), no cause is found in a sizable minority (nearly half). Interest has been growing in whether the anaemia in some of these individuals might be caused by the bacterium Helicobacter pylori, which resides in the stomachs of about 40% of Australians. This bacterium can cause stomach and duodenal ulcers, which themselves can bleed and cause iron-deficiency anaemia, and, therefore, this is the principal indication to eradicate it. However, many infected individuals have no bleeding lesion despite being anaemic. In fact, although iron deficiency is usually treated initially with oral iron supplements to replenish stores, studies have suggested that H.pylori might make this treatment less effective.
This study, therefore, aims to answer the question of whether H.pylori infection is associated with failure of oral iron to replenish stores and an increased risk of recurrent iron deficiency after a course of oral iron supplements has been completed.
We aim to recruit men and post-menopausal women whose history and endoscopies do not explain the cause of their iron-deficiency. Subjects entering the study will all receive a 2 month course of oral iron therapy to replenish stores, as per their usual clinical care. H.pylori status will have been determined in most at the time of gastroscopy. In the remainder it will be determined by a simple blood test. Those who are H.pylori positive will be randomised in a 50:50 fashion to receive either H.pylori eradication therapy or no eradication therapy at the outset. Eradication therapy consists of a week’s course of two antibiotics and an acid-blocking medication (licensed and commercially available as Nexium Hp7).
Haemoglobin level and ferritin level (a measure of iron stores) will be assessed by blood test as per the usual clinical care of the patient (i.e. at the end of the course of iron, and then at 2 months, 4 months and 6 months beyond this point). If an individual’s blood test shows persistent or recurrent iron deficiency at any point, he or she will have reached an endpoint and will leave the study.
The primary outcome to be studied is the proportion of subjects who develop persistent or recurrent iron deficiency during the 6 months of follow-up. We hypothesise that this proportion will be larger in those with H.pylori who do not receive eradication therapy, compared to those with H.pylori randomised to eradication therapy and those who are H.pylori-negative. Secondary endpoints will include the median fall in ferritin level within each group during follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27889 0
Address 27889 0
Country 27889 0
Phone 27889 0
Fax 27889 0
Email 27889 0
Contact person for public queries
Name 10975 0
Dr Shyam Prasad
Address 10975 0
Department of Gastroenterology
St Vincent's Hospital
35 Victoria Parade
Fitzroy VIC 3065
Country 10975 0
Australia
Phone 10975 0
+61 3 92883534
Fax 10975 0
+61 3 9288 3590
Email 10975 0
[email protected]
Contact person for scientific queries
Name 1903 0
Dr Andrew Taylor
Address 1903 0
Department of Gastroenterology
St Vincent's Hospital
35 Victoria Parade
Fitzroy VIC 3065
Country 1903 0
Australia
Phone 1903 0
+61 3 92883580
Fax 1903 0
+61 3 92883590
Email 1903 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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