GI Effects of Iron in Healthy Volunteers

NCT04705662 | Completed

• 1 other identifier: FGC-20-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

ferrous sulphate

Outcome Measures

Primary Outcomes (1)

• 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).

  4 weeks apart

Secondary Outcomes (4)

• Volatile organic compounds (VOC) in breath

  4 weeks apart

• Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)

  4 weeks apart

• Stool consistency via the Bristol Stool Chart

  4 weeks apart

• Gut Microbiome analysis via stool samples

  4 weeks

Study Arms (1)

Ferrous Sulphate

OTHER

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.

Diagnostic Test: Lactulose breath test; Other: Stool sample; Other: Daily Diary; Other: Irritable Bowel syndrome severity scoring system (IBS-SSS) questionnaire; Dietary Supplement: Ferrous Sulphate

Interventions

Lactulose breath test DIAGNOSTIC_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.

Ferrous Sulphate

Stool sample OTHER

Participants will provide a stool sample pre and post iron supplementation

Ferrous Sulphate

Daily Diary OTHER

Monitoring stool form, consistency and frequency on a daily basis

Ferrous Sulphate

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

Participants will complete the questionnaire pre and post iron supplementation

Ferrous Sulphate

Ferrous Sulphate DIETARY_SUPPLEMENT

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

Ferrous Sulphate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Anthony Hobson: lead
• Anglia Ruskin University: collaborator

Study Sites (2)

The Functional Gut Clinic

Cambridge, Greater Manchester, M2 4NG, United Kingdom

Location

The Functional Gut Clinic

Manchester, Greater Manchester, M3 4BG, United Kingdom

Location

MeSH Terms

Conditions

Communicable Diseases; Anemia, Iron-Deficiency

Interventions

Surveys and Questionnaires; ferrous sulfate

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anthony Hobson

  The Functional Gut Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Clinical Scientist

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 12, 2021
• Study Start: March 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)