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Clinical Trial Summary

Many patients that are prescribed iron report gastrointestinal side effects. This research project aims to investigate if the gastrointestinal symptoms of taking iron supplementation are related to changes in gases produced by bacteria in the gastrointestinal tract.


Clinical Trial Description

This study is a pre-post interventional, two armed prospective cohort study where patients who are newly diagnosed with iron deficiency anaemia are prescribed iron therapy (either oral iron supplements, 200mg capsules containing 65mg of iron 2-3 times daily, or intravenous iron 1000-1500mg) as part of their standard care. Participants will be asked to provide breath samples and complete the IBS-SSS questionnaire at baseline and after 4 weeks of taking the iron therapy as part of their standard care. A diary including stool consistency and frequency will also be completed by participants on a daily basis. For further exploratory research, some participants from each the oral and IV iron arm will be asked to provide stool samples at baseline and 4-weeks post iron therapy to assess any microbiome changes in response to iron therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04253652
Study type Observational
Source The Functional Gut Clinic
Contact Anthony Hobson
Phone 01613027777
Email anthony@thefunctionalgutclinic.com
Status Not yet recruiting
Phase
Start date March 9, 2023
Completion date December 2024

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