NCT04705662

GI Effects of Iron in Healthy Volunteers

Investigating the Effects of Iron on the Gastrointestinal Tract in Health.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dr Anthony Hobson · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Over recent years there has been a lot of research looking at how the bacteria in our gut affects our health. Some medications are known to cause changes in gut bacteria. Many patients that are prescribed iron report gastrointestinal side effects. This research project aims to see if the cause of the gastrointestinal side effects is due to iron causing changes in the gut bacteria. This can be detected via measuring the levels of hydrogen and methane and other compounds in the breath and stool.

Detailed description

Iron deficiency anaemia is the most common health issue worldwide, with approximately \>1.2 billion people affected. In the UK, iron deficiency anaemia most commonly affects pre-school aged children and women aged 15-49 years. In 2011, an estimated 14% of non-pregnant, and 23% of pregnant women in the UK had iron deficiency anaemia, and 2-5% of male and post-menopausal women were also affected. Whilst compared to other areas of the world IDA has a mild public health significance to the UK, it can be the reason for up-to 13% of referrals to gastroenterologists. Treating IDA with oral supplements or IV infusions are both effective at restoring bodily iron stores. However, success is often greater in those receiving their iron intravenously, due to frequent non-adherence to oral tablets as a result of their side effects. Gastrointestinal complaints, most commonly constipation, are reported by up to 60% of people that take oral iron supplements. These GI complaints causes up to 50% of patient to not follow their treatment plan, meaning their iron deficiency anaemia persists. However, patients that receive intravenous iron infusions instead do not report these symptoms. This suggests that oral iron has an impact on the GI tract as intravenous iron will bypass the gastrointestinal lumen but the mechanism of this remains uncertain. To investigate the side effects of oral iron supplements and research a potential mechanism for the cause of iron supplement side effects, this study will require healthy volunteers to take ferrous sulphate for 4 weeks. Pre and post intervention participants will be required to provide a stool sample, complete a breath test and answer questionnaires.

Conditions

• Iron Deficiency Anemia Treatment
• Microbial Colonization
• Iron-deficiency
• Iron Deficiency Anemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lactulose breath test	Participants will complete a 3 hour breath test pre and post iron supplementation. This will include taking 4 exploratory samples for volatile organic compound (VOC) analysis.
OTHER	Stool sample	Participants will provide a stool sample pre and post iron supplementation
OTHER	Daily Diary	Monitoring stool form, consistency and frequency on a daily basis
OTHER	Irritable Bowel syndrome severity scoring system (IBS-SSS) questionnaire	Participants will complete the questionnaire pre and post iron supplementation
DIETARY_SUPPLEMENT	Ferrous Sulphate	Participants will take Ferrous sulphate 200mg (65mg elemental iron) for 4 weeks (+/- 2 days). Participants will be required to take 2 tablets per day.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-01-12
• Last updated: 2025-04-22

Locations

2 sites across 1 country: United Kingdom