Probiotic to improve iron levels and blood health during pregnancy

Mechanistic Pathways of Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females at Risk of Iron Deficiency Anemia

This trial will test whether taking the probiotic Lactiplantibacillus plantarum 299v can help pregnant people at risk of iron deficiency improve their iron and blood levels.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University of Illinois at Chicago (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT07076849 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Pregnant people aged 18–45 with a singleton natural conception at 10–16 weeks gestation who have hemoglobin in the at-risk range (per protocol), can consent in English, and can attend visits at the study site are ideal candidates.

Not a fit: People with established iron deficiency anemia, other nutritional or hematologic disorders, recent blood transfusion, inflammatory bowel disease, recent antibiotic use, prior bariatric surgery, or other exclusionary conditions are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the probiotic could reduce the development of iron deficiency in pregnancy and lower the need for oral iron supplements with their gastrointestinal side effects.

How similar studies have performed: Prior small trials and mechanistic studies suggest Lactiplantibacillus plantarum 299v can enhance non-heme iron absorption, but evidence in pregnant populations is limited and not yet definitive.

Eligibility criteria

Inclusion Criteria:

* singleton naturally conceived pregnancy;
* at risk of IDA \[Hb 11.0 - 11.9 g/dL (first trimester) and Hb 10.5 - 11.5 g/dL (second trimester) based on new OB clinical complete blood count (CBC) results obtained from the EHR;
* 18 - 45 years old;
* 10-16 weeks GA;
* fluency in English to provide consent and complete study procedures;
* ability to provide consent;
* and ownership of a smartphone (currently more than 90% of our patient population at the CWH).

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 this trial is running

Chicago, Illinois

• University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Mary Dawn Koenig, PhD, RN, CNM

Conditions Iron Deficiency; Pregnancy