Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron

NCT ID: NCT02131870

Last Updated: 2014-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Study Groups

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L plantarum DSM 9843

Group Type ACTIVE_COMPARATOR

L plantarum DSM 9843 or placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

L plantarum DSM 9843 or placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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L plantarum DSM 9843 or placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Probi AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Internal Medicin and Clinical Nutrition, the Sahlgrenska Academy, Gothenburg University

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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Hoppe M, Onning G, Hulthen L. Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females-Double isotope sequential single-blind studies in menstruating women. PLoS One. 2017 Dec 13;12(12):e0189141. doi: 10.1371/journal.pone.0189141. eCollection 2017.

Reference Type DERIVED
PMID: 29236734 (View on PubMed)

Other Identifiers

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ProIron

Identifier Type: -

Identifier Source: org_study_id

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