GI Effects of Iron in Healthy Volunteers
Condition: Iron Deficiency Anemia Treatment; Microbial Colonization; Iron-deficiency; Iron Deficiency Anemia
MeSH terms: Communicable Diseases; Infections; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

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.
    

Intervention name(s): Lactulose breath test; Stool sample; Daily Diary; Irritable Bowel syndrome severity scoring system (IBS-SSS) questionnaire; Ferrous Sulphate
Intervention type(s): Diagnostic Test; Other; Other; Other; Dietary Supplement
Intervention description(s): 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.; Participants will provide a stool sample pre and post iron supplementation; Monitoring stool form, consistency and frequency on a daily basis; Participants will complete the questionnaire pre and post iron supplementation; Participants will take Ferrous sulphate 200mg (65mg elemental iron) for 4 weeks (+/- 2 days). Participants will be required to take 2 tablets per day.
Intervention MeSH terms: Lactulose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ferrous sulphate