Status:
COMPLETED
GI Effects of Iron in Healthy Volunteers
Lead Sponsor:
Dr Anthony Hobson
Collaborating Sponsors:
Anglia Ruskin University
Conditions:
Iron Deficiency Anemia Treatment
Microbial Colonization
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 presc...
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 a...
Eligibility Criteria
Inclusion
- Participant has provided 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.
- Participant is a male or non-pregnant female (confirmed by pregnancy test) and is age 18 years to 60 years.
- Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
- Participant has capacity to understand written English.
- Participant has no significant medical diagnosis or current or previous chronic gastrointestinal disease requiring medication or surgery (apart from appendectomy). Participant has no disease that would contraindicate iron supplementation e.g. haemochromatosis.
- Participant is not on regular prescription medicines unless a stable dose for the past 6-months and duration of the trial.
- Participant has a body mass index (BMI) of 18.5 - 34.9 kg/m2 (bounds included).
- 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.
- Participant agrees to refrain from smoking on the day of the breath test.
- Participant agrees to 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.
- Participant agrees to not take any probiotic for 14 days before the breath test or during the study.
- Participant has not taken antibiotics for 4-weeks before the start of the study or during the study
Exclusion
- Participant has no significant medical diagnosis or current or previous chronic gastrointestinal disease requiring medication or surgery (apart from appendectomy). Participant has no disease that would contraindicate iron supplementation e.g. haemochromatosis.
- Participant is pregnant or breast feeding.
- Participant takes medication known to impact the gut microbiome:
- Antibiotics used in the last 4 weeks
- Regular use of laxatives or anti-diarrheal medication
- Participant is taking a regular prescription medication that has a contraindication with oral iron supplementation.
- Participant has undergone a colonoscopy/sigmoidoscopy in the 1 week prior to enrolment.
- Participant regularly consumes probiotics, prebiotics, fibre supplements in the 4 weeks prior to enrolment and/or is unwilling to exclude the use of probiotics from the diet during the study period.
- Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or sponsor member.
- Participant has had previous abdominal or colorectal surgery except appendectomy or hysterectomy.
- Participant has had oral iron supplementation of IV iron supplementation in the 12 months prior to enrolment.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04705662
Start Date
March 1 2021
End Date
June 30 2022
Last Update
April 22 2025
Active Locations (2)
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1
The Functional Gut Clinic
Cambridge, Greater Manchester, United Kingdom, M2 4NG
2
The Functional Gut Clinic
Manchester, Greater Manchester, United Kingdom, M3 4BG