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GI Effects of Iron in Healthy Volunteers

Primary Purpose

Iron Deficiency Anemia Treatment, Microbial Colonization, Iron-deficiency

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Lactulose breath test

Stool sample

Daily Diary

Irritable Bowel syndrome severity scoring system (IBS-SSS) questionnaire

Ferrous Sulphate

About this trial

This is an interventional basic science trial for Iron Deficiency Anemia Treatment focused on measuring ferrous sulphate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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:
1. Antibiotics used in the last 4 weeks
2. 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.

Sites / Locations

The Functional Gut Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ferrous Sulphate

Arm Description

This is a single arm study, all participants will take Ferrous sulphate 200mg (65mg elemental iron) for 4 weeks (+/- 2 days). Participants will be required to take 2 tablets per day.

Outcomes

Primary Outcome Measures

Breath methane levels

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).

Secondary Outcome Measures

Volatile organic compounds (VOC) in breath

Difference in any breath gas markers. This is exploratory so will look to see what is present at baseline and see how it changes over the 4 week study period.

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.

Stool consistency via the Bristol Stool Chart

Change in stool frequency and form according to the bristol stool chart scale from baseline to 4 weeks since commencing iron therapy.

Gut Microbiome analysis via stool samples

Qualitative and Quantitative data for faecal microorganisms at baseline and 4-weeks since commencing iron therapy.

Full Information

NCT ID

NCT04705662

First Posted

January 5, 2021

Last Updated

October 18, 2022

Sponsor

Dr Anthony Hobson

Collaborators

Anglia Ruskin University

1. Study Identification

Unique Protocol Identification Number

NCT04705662

Brief Title

GI Effects of Iron in Healthy Volunteers

Official Title

Investigating the Effects of Iron on the Gastrointestinal Tract in Health.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr Anthony Hobson

Collaborators

Anglia Ruskin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

ferrous sulphate

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ferrous Sulphate

Arm Type

Other

Arm Description

This is a single arm study, all 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 Type

Diagnostic Test

Intervention Name(s)

Lactulose breath test

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Stool sample

Intervention Description

Participants will provide a stool sample pre and post iron supplementation

Intervention Type

Other

Intervention Name(s)

Daily Diary

Intervention Description

Monitoring stool form, consistency and frequency on a daily basis

Intervention Type

Other

Intervention Name(s)

Irritable Bowel syndrome severity scoring system (IBS-SSS) questionnaire

Intervention Description

Participants will complete the questionnaire pre and post iron supplementation

Intervention Type

Dietary Supplement

Intervention Name(s)

Ferrous Sulphate

Intervention Description

Participants will take Ferrous sulphate 200mg (65mg elemental iron) for 4 weeks (+/- 2 days). Participants will be required to take 2 tablets per day.

Primary Outcome Measure Information:

Title

Breath methane levels

Description

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).

Time Frame

4 weeks apart

Secondary Outcome Measure Information:

Title

Volatile organic compounds (VOC) in breath

Description

Difference in any breath gas markers. This is exploratory so will look to see what is present at baseline and see how it changes over the 4 week study period.

Time Frame

4 weeks apart

Title

Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)

Description

Time Frame

4 weeks apart

Title

Stool consistency via the Bristol Stool Chart

Description

Change in stool frequency and form according to the bristol stool chart scale from baseline to 4 weeks since commencing iron therapy.

Time Frame

4 weeks apart

Title

Gut Microbiome analysis via stool samples

Description

Qualitative and Quantitative data for faecal microorganisms at baseline and 4-weeks since commencing iron therapy.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Hobson

Organizational Affiliation

The Functional Gut Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

The Functional Gut Clinic

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M3 4BG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Results will be written up and published in journal articles and presented at conferences

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GI Effects of Iron in Healthy Volunteers

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