NCT04253652

Investigating the Effects of Iron on the Gastrointestinal Tract

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 155 (estimated)
• Sponsor: The Functional Gut Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Iron Deficiency Anemia
• Constipation

Interventions

Type	Name	Description
OTHER	Fasted breath samples	Will be completed pre and post iron therapy
OTHER	IBS-SSS	Will be completed pre and post iron therapy
OTHER	Daily diary	Monitoring stool form, consistency and frequency on a daily basis for 4 weeks
OTHER	Exploratory research: stool samples	Completed pre and post iron therapy for a subset of patients enrolled in the study

Timeline

• Start date: 2023-03-09
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2020-02-05
• Last updated: 2022-10-19

Locations

1 site across 1 country: United Kingdom