Status:
UNKNOWN
Can Prebiotics Support the Treatment of Mild Iron Deficiency by Iron Supplementation
Lead Sponsor:
Gemma Walton
Collaborating Sponsors:
Biotechnology and Biological Sciences Research Council
Conditions:
Healthy
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The first aim of this study is to investigate if daily administration of the prebiotic Synergy-1 (a commercial product consisting of oligofructose-enriched inulin) together with a common iron suppleme...
Detailed Description
This will be a crossover, placebo controlled, and randomised pilot study in 15 pre-menopausal female individuals with ferritin levels below 40 mcg/l but normal hemoglobin (Hb) and C reactive protein (...
Eligibility Criteria
Inclusion
- Age: 18-50 years
- Gender: Female
- Volunteers agree to sign an informal written consent form
- General good health
- Have ferritin levels below 40 mcg/l
- Normal or borderline-low hemoglobin levels (\>11.5g/dL)
Exclusion
- Use of antibiotics, prebiotics or probiotics (in food products or as supplements), laxatives, anti-spasmodic, anti-diarrhoea drugs, (e.g. Orlistat, Lactulose) in the last 4 weeks prior to, or during the study period.
- Use of any iron supplement in the last 6 months prior to the study period.
- If participants have received bowel preparation for investigative procedures in the 4 weeks prior to the study.
- Surgical resection of any part of the bowel.
- If participants are taking any medication whose effectiveness could be reduced by the iron administration (e.g. Levodopa, Levothyroxine).
- If participants have any chronic gut disorder/disease, such as inflammatory bowel syndrome (IBS), inflammatory bowel disease (IBD), etc. or other conditions that might affect the gut environment, e.g. coeliac disease.
- If participants are taking any medication that could affect the iron absorption (e.g. lansoprazole, omeprazole).
- If participants are pregnant or are lactating.
- If participants have a body mass index (BMI) \> 30 kg/m2.
- Severe allergy or any history of severe abnormal drug reaction, drug or alcohol abuse.
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03850652
Start Date
March 6 2019
End Date
January 1 2020
Last Update
March 6 2019
Active Locations (1)
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1
University of Reading
Reading, United Kingdom, RG6 6AP