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 origi

Phase 4

• Conditions: Iron deficiency with no cause found on gastroscopy, colonoscopy and duodenal biopsy; Blood - Other blood disorders

• Registration Number: ACTRN12607000287437
• Lead Sponsor: St Vincent's Health (Melbourne) Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 105

Inclusion Criteria

Iron-deficiencyWilling to participate in studyAble to comply with requirements of study, including duration and blood testing.

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

• Study Type: Interventional
• Study Design: Not specified