CClinicalTrials.gg
CompletedNCT02912416Updated Mar 4, 2020

Efficacy of Probiotics on Iron Status During Pregnancy

An interventional study of Probiotics and Placebo in Prevention of Iron Deficiency, sponsored by Probi AB. Completed at 1 site in Sweden. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-04.

Sponsored by Probi AB · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
326
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Prevention of Iron Deficiency

Browse trials for

03

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
326 participants (actual)

Study arms

  • Experimental
    Probiotics

    Capsule with probiotics

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo

    Capsule with placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotics
  • Dietary supplementPlacebo
05

What researchers measure

Primary outcomes

  1. Serum ferritin level

    Time frame: Week 28 of gestation

06

Study locations

1 site
  • CuraÖresund
    Malmö, 205 12, Sweden
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02912416
Lead sponsor
Probi AB
Responsible party
Sponsor
First posted
Sep 23, 2016
Start date
Sep 9, 2016
Primary completion
Nov 11, 2018
Completion
Nov 11, 2018
Last update
Mar 4, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion