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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02131870
Other study ID # ProIron
Secondary ID
Status Completed
Phase N/A
First received April 30, 2014
Last updated August 13, 2014

Study information

Verified date August 2014
Source Probi AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to study the effect of a probiotic product on iron absorption in healthy females of child-bearing age.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria:

- Female

- Age =19 and =45 years

- Hb >117g/L

Exclusion Criteria:

- Gastrointestinal diseases

- Metabolic diseases

- Use of other probiotic products during the study and 2 weeks before the study start

- Pregnant or breast-feeding

- A serum ferritin level >60 µg/L

- Medication (oral contraceptives allowed)

- Intake of dietary supplements (incl. iron) during the study and two weeks before the study start

- No blood donation in the last 2 months

- High C-reactive protein levels

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
L plantarum DSM 9843 or placebo


Locations

Country Name City State
Sweden Department of Internal Medicin and Clinical Nutrition, the Sahlgrenska Academy, Gothenburg University Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Probi AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Iron absorption ratio in blood samples Iron absorption will be estimated by measuring the isotope ratio (55Fe/59Fe) in blood after addition of iron isotopes in test meals (55Fe in placebo meal, 59Fe in L plantarum DSM 9843 meal). 14 days No
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