Efficacy of Probiotics on Iron Status During Pregnancy

Not Applicable

Completed

• Conditions: Prevention of Iron Deficiency
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT02912416
• Lead Sponsor: Probi AB

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-09
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Primary Completion: 2018-11-11
• Study Completion: 2018-11-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotics	Capsule with probiotics
Placebo	Placebo	Capsule with placebo

Primary Outcome Measures

Name	Time	Method
Serum ferritin level	Week 28 of gestation

Trial Locations

Locations (1)

CuraÖresund; 🇸🇪 Malmö, Sweden