Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: L plantarum DSM 9843 or placebo

• Registration Number: NCT02131870
• Lead Sponsor: Probi AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-06
• Primary Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
L plantarum DSM 9843	L plantarum DSM 9843 or placebo	-
Placebo	L plantarum DSM 9843 or placebo	-

Primary Outcome Measures

Name	Time	Method
Iron absorption ratio in blood samples	14 days	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).

Trial Locations

Locations (1)

Department of Internal Medicin and Clinical Nutrition, the Sahlgrenska Academy, Gothenburg University; 🇸🇪 Gothenburg, Sweden