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Investigating the Effects of Iron on the Gastrointestinal Tract (GI-iron)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253652
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Anglia Ruskin University
Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Dr Anthony Hobson, The Functional Gut Clinic

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.

Condition or disease Intervention/treatment
Iron Deficiency Anemia Constipation Other: Fasted breath samples Other: IBS-SSS Other: Daily diary Other: Exploratory research: stool samples

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.

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Study Type : Observational
Estimated Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating the Effects of Iron on the Gastrointestinal Tract
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Group/Cohort Intervention/treatment
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.
Other: Fasted breath samples
Will be completed pre and post iron therapy

Other: IBS-SSS
Will be completed pre and post iron therapy

Other: Daily diary
Monitoring stool form, consistency and frequency on a daily basis for 4 weeks

Other: Exploratory research: stool samples
Completed pre and post iron therapy for a subset of patients enrolled in the study

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
Other: Fasted breath samples
Will be completed pre and post iron therapy

Other: IBS-SSS
Will be completed pre and post iron therapy

Other: Daily diary
Monitoring stool form, consistency and frequency on a daily basis for 4 weeks

Other: Exploratory research: stool samples
Completed pre and post iron therapy for a subset of patients enrolled in the study




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) [ Time Frame: 4 weeks apart ]
    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.

  2. Stool consistency [ Time Frame: 4 weeks apart ]
    Change in stool frequency and form according to the bristol stool chart and abdominal symptoms during the 4 weeks since commencing iron therapy.


Other Outcome Measures:
  1. Exploratory [ Time Frame: 4 weeks apart ]
    Qualitative and Quantitative data for faecal microorganisms at baseline and 4-weeks since commencing iron therapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 oral iron participants 55 IV iron participants
Criteria

Inclusion Criteria:

  1. 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.
  2. Male or non-pregnant female and is age 18 years to 80 years.
  3. Can communicate well with the Investigator and to comply with the requirements for the entire study.
  4. Capacity to understand written English.
  5. New diagnosis iron-deficient anaemia.
  6. 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.
  7. Participant agrees to wait until after taking baseline breath samples and completing the IBS-SSS questionnaire before starting their iron therapy.
  8. Participant agrees to follow pre-test diet for 24 hours before giving test sample.
  9. Participant agrees to refrain from strenuous physical activity on the day of the breath test.
  10. Refrain from smoking on the day of the breath test.
  11. 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.
  12. No probiotics for 14 days before the breath test or during the study.
  13. Body mass index between 18.5 and 34.9kg/m2 (bounds included).
  14. Not antibiotics for 4-weeks before the start of the study or during the study

Exclusion Criteria:

  1. Using an opioid based medication.
  2. Antibiotics in the 4 weeks prior to enrolment.
  3. 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.
  4. Diagnosis of any organic gastrointestinal disease, including inflammatory bowel disease, coeliac disease and diverticulitis.
  5. Mechanical obstruction of the GI tract.
  6. Participant is diabetic.
  7. Participant has any hepatic disease.
  8. Participant has any disease of the CNS.
  9. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or sponsor member.
  10. Previous abdominal or colorectal surgery except appendectomy, cholecystectomy, or hysterectomy.
  11. Participant has had iron therapy in the 12 months prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253652


Locations
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United Kingdom
Sheffield Teaching Hospitals
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
The Functional Gut Clinic
Anglia Ruskin University
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Anthony Hobson The Functional Gut Clinic
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Responsible Party: Dr Anthony Hobson, Consultant Clinical Scientist, The Functional Gut Clinic
ClinicalTrials.gov Identifier: NCT04253652    
Other Study ID Numbers: FGC19002
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases