GI Effects of Iron in Healthy Volunteers

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Anglia Ruskin University

  collaborator OTHER

• Dr Anthony Hobson

  lead OTHER

Principal Investigators

• Anthony Hobson · The Functional Gut Clinic

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2022-06-30

Completion

2022-06-30

Countries

• United Kingdom

Study Locations