Recruiting at 1 site Phase 2 Iron Deficiency (ID)

Clinical trial for Iron Deficiency (ID)

Official title Probiotic Supplementation in Optimizing Iron and Hematological Status Among Pregnant Females

ClinicalTrials.gov ID: NCT07076849

What this study is testing

Who it's for
You may be able to join if you are pregnant and have low iron levels.
What's involved
You would take a probiotic pill twice a day. You would also give blood samples during your pregnancy.
Time commitment
The study lasts from 10 to 16 weeks of pregnancy until you give birth.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 45, women only. Healthy volunteers may be eligible.

You may be able to join if

  • 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)...
  • 18 - 45 years old;
  • 10-22 weeks GA;
  • fluency in English to provide consent and complete study procedures;

You likely can't join if

  • 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...
  • recent blood transfusion;
  • autoimmune disorder (e.g., rheumatoid arthritis);
  • inflammatory bowel disease;
  • oral or IV antibiotic use within 2 months;
  • previous spontaneous preterm birth;
See the full eligibility criteria
Who can join
  • 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;
What rules you out
  • 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).

The study team makes the final eligibility decision.

Where it is enrolling

  • Chicago, Illinois, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.