NCT02131870

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

First QC Date

April 30, 2014

Last Update Submit

August 13, 2014

Conditions

Healthy

Keywords

iron absorptionhealthy femaleschild bearing age

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

L plantarum DSM 9843

ACTIVE COMPARATOR
Dietary Supplement: L plantarum DSM 9843 or placebo

Placebo

PLACEBO COMPARATOR
Dietary Supplement: L plantarum DSM 9843 or placebo

Interventions

L plantarum DSM 9843 or placeboDIETARY_SUPPLEMENT
L plantarum DSM 9843Placebo

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Age ≥19 and ≤45 years
  • Hb \>117g/L

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Gothenburg, 405 30, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 29236734DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 6, 2014

Primary Completion

July 1, 2014

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

SE(1)