Probiotic to improve iron levels and blood health during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study enrolls pregnant people at 10–16 weeks gestation who are at risk for iron deficiency based on specific hemoglobin ranges. Participants will take daily capsules of Lactiplantibacillus plantarum 299v or matching placebo and have hematologic and iron markers monitored during pregnancy. The probiotic is hypothesized to enhance non-heme iron absorption by altering gut microbiota, lowering intestinal pH, increasing mucin production, and promoting an anti-inflammatory intestinal environment. Study visits include blood testing and follow-up at the University of Illinois at Chicago to track iron status and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* singleton naturally conceived pregnancy;
* at risk of IDA \[Hb 11.0 - 13.0 g/dL (first trimester) and Hb 10.5 - 12.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC) results obtained from the EHR;
* 18 - 45 years old;
* 10-22 weeks GA;
* fluency in English to provide consent and complete study procedures;
* ability to provide consent;

Exclusion Criteria:

* IDA or other nutritional anemia (i.e., diagnosed or suspected B12 or folate deficiency) based on new OB blood work that includes MCV and MCH to characterize the anemia;
* recent blood transfusion;
* autoimmune disorder (e.g., rheumatoid arthritis);
* inflammatory bowel disease;
* oral or IV antibiotic use within 2 months;
* previous spontaneous preterm birth;
* history of bariatric surgery;
* malabsorptive disease;
* current hyperemesis;
* current eating disorder;
* hematologic disorder or trait carrier (e.g., hemochromatosis, β-thalassemia);
* current tobacco, alcohol or illicit drug use (Excluding marijuana).

Where it's running

• University of Illinois at Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Mary Dawn Koenig, PhD, RN, CNM
• Email: marydh@uic.edu
• Phone: 312-996-7982

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.