Efficacy of Probiotics on Iron Status During Pregnancy

Prevention of Iron Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912416
• Other study ID #: ProIron 16
• Status: Completed
• Phase: N/A
• Start date: September 9, 2016
• Est. completion date: November 11, 2018

Study information

• Verified date: March 2020
• Source: Probi AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: November 11, 2018
• Est. primary completion date: November 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Prevention of Iron Deficiency

Intervention

Dietary Supplement:
• Probiotics

• Placebo

Locations

Country	Name	City	State
Sweden	CuraÖresund	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Probi AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum ferritin level		Week 28 of gestation