ANZCTR - Registration

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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

Condition category

Condition code

Blood

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]

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]

Persistent or recurrent iron deficiency over 8 months of follow-up

Timepoint [1]

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]

Rate of fall of blood ferritin level measured by venous blood samples

Timepoint [1]

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?

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]

Charities/Societies/Foundations

Name [1]

Department of Gastroenterology, St Vincent's Health (Melbourne) Ltd

Address [1]

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

St Vincent's Health (Melbourne) Ltd

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

St Vincent's Health (Melbourne) Ltd

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Shyam Prasad

Address

Department of Gastroenterology
St Vincent's Hospital
35 Victoria Parade
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 92883534

Fax

+61 3 9288 3590

shyam.prasad@svhm.org.au

Contact person for scientific queries

Name

Dr Andrew Taylor

Address

Department of Gastroenterology
St Vincent's Hospital
35 Victoria Parade
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 92883580

Fax

+61 3 92883590

andrew.taylor@svhm.org.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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