Efficacy of Probiotics on Iron Status During Pregnancy

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

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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