Prevention of Iron Deficiency
Conditions
Brief summary
Determine the effect of probiotics on improving iron status in a population of healthy, pregnant women.
Interventions
DIETARY_SUPPLEMENTPlacebo
DIETARY_SUPPLEMENTProbiotics
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum ferritin level | Week 28 of gestation |
Countries
Sweden
Outcome results
None listed