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OpenTrials
Completed

NCT Number: NCT02912416

Efficacy of Probiotics on Iron Status During Pregnancy

Determine the effect of probiotics on improving iron status in a population of healthy, pregnant women.

Completed

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CuraÖresund

Malmö, 205 12, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, pregnant women, aged 18-42 years, with a singleton gestation
  • Inclusion at 10-12 weeks of gestation
  • BMI ≥ 18 and ≤ 30 at baseline
  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures

Exclusion criteria

  • Serum ferritin level <20 µg/L or Hb<110 g/L at baseline (visit 1)
  • Chronic diseases associated with anemia
  • Known Thalassemia
  • Hyperemesis gravidarum
  • Chronic gastrointestinal disease (inflammable bowel diseases; Crohn's disease, Ulcerative Colitis; diarrheal disease)
  • Known gluten intolerance, lactose intolerance, milk protein allergy
  • Taking antibiotics within four weeks before inclusion
  • Blood or plasma donation within three (3) months prior to baseline
  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  • Smoking or use of nicotine-containing products (currently or during the last three [3] months)
  • History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator
  • Hypersensitivity to any of the ingredients in the study products
  • Any other reason for exclusion, as judged by the Investigator

Treatment and study plan

Probiotics

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Serum ferritin level

    Time frame: Week 28 of gestation

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 23, 2016
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.