Iron Deficiency AnemiaGI-ironNCT04253652
Investigating the Effects of Iron on the Gastrointestinal Tract
An observational study of Iron Deficiency Anemia and Constipation, run by The Functional Gut Clinic at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Iron Deficiency Anemia, Constipation
- What is being tested?
- Fasted breath samples, IBS-SSS and Daily diary
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Mar 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 oral iron participants 55 IV iron participants
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals
Sheffield, S5 7AU
John Hebden, 01142434343
About this study
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.
Read the 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
- Being tested
- Fasted breath samples, IBS-SSS, Daily diary, Exploratory research: stool samples
- Medical subject headings
- Anemia, Iron-Deficiency, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasted breath samplesOther
Will be completed pre and post iron therapy
IBS-SSSOther
Will be completed pre and post iron therapy
Daily diaryOther
Monitoring stool form, consistency and frequency on a daily basis for 4 weeks
Exploratory research: stool samplesOther
Completed pre and post iron therapy for a subset of patients enrolled in the study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fasted breath samples; Other: IBS-SSS; Other: Daily diary; Other: Exploratory research: stool samples | |
| 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 Receives: Other: Fasted breath samples; Other: IBS-SSS; Other: Daily diary; Other: Exploratory research: stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks apart
Secondary outcomes (2)
Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Comparison in change of IBS-SSS score from baseline to 4 weeks since commencing iron therapy. The minimum score is 0 and maximum score is 500. The greater the score, the worse the severity and frequency of symptoms of abdominal pain and distention, and increased dissatisfaction of overall bowel functioning.
Measured: 4 weeks apart
Stool consistency
Change in stool frequency and form according to the bristol stool chart and abdominal symptoms during the 4 weeks since commencing iron therapy.
Measured: 4 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start9 Mar 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Functional Gut Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University, Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Anthony Hobson, The Functional Gut Clinic
- Investigators
- Anthony Hobson, Principal investigator, The Functional Gut Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253652
- Sponsor's protocol ID
- FGC19002
- Acronym
- GI-iron
- Status last verified
- Oct 2022
- First submitted
- 31 Jan 2020
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Iron on the Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT04253652
- Acronym / sponsor ID
- GI-iron / FGC19002
- Conditions
- Iron Deficiency Anemia, Constipation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- The Functional Gut ClinicUniversity, hospital or other
- Collaborators
- Anglia Ruskin University, Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 9 Mar 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral iron | – | Other: Fasted breath samples, Other: IBS-SSS, Other: Daily diary, Other: Exploratory research: stool samplesThese 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 | – | Other: Fasted breath samples, Other: IBS-SSS, Other: Daily diary, Other: Exploratory research: stool samplesThese 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 oral iron participants 55 IV iron participants
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasted breath samplesWill be completed pre and post iron therapy | Other | Intravenous iron, Oral iron |
| IBS-SSSWill be completed pre and post iron therapy | Other | Intravenous iron, Oral iron |
| Daily diaryMonitoring stool form, consistency and frequency on a daily basis for 4 weeks | Other | Intravenous iron, Oral iron |
| Exploratory research: stool samplesCompleted pre and post iron therapy for a subset of patients enrolled in the study | Other | Intravenous iron, Oral iron |
Primary outcome
Breath
Time frame: 4 weeks apart
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).
2 secondary outcomes
Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Time frame: 4 weeks apart
Stool consistency
Time frame: 4 weeks apart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Hobson principal investigator
The Functional Gut Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia and Constipation, run by The Functional Gut Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Hobson (01613027777, anthony@thefunctionalgutclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath (time frame: 4 weeks apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.