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Efficacy of Probiotics on Iron Status During Pregnancy

P

Probi AB

Status

Completed

Conditions

Prevention of Iron Deficiency

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Probiotics

Study type

Interventional

Funder types

Industry

Identifiers

NCT02912416
ProIron 16

Details and patient eligibility

About

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

Enrollment

326 patients

Sex

Female

Ages

18 to 42 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

326 participants in 2 patient groups, including a placebo group

Probiotics
Experimental group
Description:
Capsule with probiotics
Treatment:
Dietary Supplement: Probiotics
Placebo
Placebo Comparator group
Description:
Capsule with placebo
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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