Investigating the Effects of Iron on the Gastrointestinal Tract
GI-iron
1 other identifier
observational
155
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 19, 2022
October 1, 2022
1.5 years
January 31, 2020
October 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Breath
Difference in methane levels in breath samples from baseline and 4-weeks since commencing iron therapy. This will be measured in parts per million (ppm).
4 weeks apart
Secondary Outcomes (2)
Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
4 weeks apart
Stool consistency
4 weeks apart
Other Outcomes (1)
Exploratory
4 weeks apart
Study Arms (2)
Oral iron
These patients will have diagnosed with iron deficiency anaemia and been prescribed oral iron supplements as part of their treatment from their doctor. This will be in accordance with the NICE guidelines; 200mg capsules containing 65mg elemental iron, 2-3 times a day for a period of atleast 1 month.
Intravenous iron
These patients will have diagnosed with iron deficiency anaemia and been prescribed intravenous iron as part of their treatment from their doctor. Participants will receive an infusion of either 1000mg or 1500mg
Interventions
Monitoring stool form, consistency and frequency on a daily basis for 4 weeks
Completed pre and post iron therapy for a subset of patients enrolled in the study
Eligibility Criteria
100 oral iron participants 55 IV iron participants
You may qualify if:
- Written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
- Male or non-pregnant female and is age 18 years to 80 years.
- Can communicate well with the Investigator and to comply with the requirements for the entire study.
- Capacity to understand written English.
- New diagnosis iron-deficient anaemia.
- Prescribed IV iron therapy or oral iron supplementation which contains 65mg elemental iron, two or three times per day for a period of at least 1 month or, will receive 1000mg or 1500mg of intravenous iron, as part of their standard care.
- Participant agrees to wait until after taking baseline breath samples and completing the IBS-SSS questionnaire before starting their iron therapy.
- Participant agrees to follow pre-test diet for 24 hours before giving test sample.
- Participant agrees to refrain from strenuous physical activity on the day of the breath test.
- Refrain from smoking on the day of the breath test.
- Agree to complete an overnight fast on the night before the breath test. Food and drink must be withheld until after all breath test samples have been taken.
- No probiotics for 14 days before the breath test or during the study.
- Body mass index between 18.5 and 34.9kg/m2 (bounds included).
- Not antibiotics for 4-weeks before the start of the study or during the study
You may not qualify if:
- Using an opioid based medication.
- Antibiotics in the 4 weeks prior to enrolment.
- Colonoscopy/sigmoidoscopy in the 1 week prior to enrolment, unless they have taken their baseline breath sample and IBS-SSS questionnaire before completing the required bowel preparation.
- Diagnosis of any organic gastrointestinal disease, including inflammatory bowel disease, coeliac disease and diverticulitis.
- Mechanical obstruction of the GI tract.
- Participant is diabetic.
- Participant has any hepatic disease.
- Participant has any disease of the CNS.
- Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or sponsor member.
- Previous abdominal or colorectal surgery except appendectomy, cholecystectomy, or hysterectomy.
- Participant has had iron therapy in the 12 months prior to enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Functional Gut Cliniclead
- Anglia Ruskin Universitycollaborator
- Sheffield Teaching Hospitals NHS Foundation Trustcollaborator
Study Sites (1)
Sheffield Teaching Hospitals
Sheffield, S5 7AU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony Hobson
The Functional Gut Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Clinical Scientist
Study Record Dates
First Submitted
January 31, 2020
First Posted
February 5, 2020
Study Start
March 9, 2023
Primary Completion
September 1, 2024
Study Completion
December 1, 2024
Last Updated
October 19, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share