Study Results
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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COMPLETED
NA
326 participants
INTERVENTIONAL
2016-09-09
2018-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Probiotics
Capsule with probiotics
Probiotics
Placebo
Capsule with placebo
Placebo
Interventions
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Probiotics
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
42 Years
FEMALE
Yes
Sponsors
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Probi AB
INDUSTRY
Responsible Party
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Locations
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CuraÖresund
Malmo, , Sweden
Countries
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Other Identifiers
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ProIron 16
Identifier Type: -
Identifier Source: org_study_id
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