Probiotic Supplementation for Iron Deficiency in Pregnancy
(ProMoms Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a probiotic supplement called Lactiplantibacillus plantarum 299v (LP299V®) to determine if it can improve iron levels in pregnant women at risk of iron deficiency. Iron deficiency during pregnancy can lead to serious health issues for both mother and baby, so managing it effectively is crucial. The trial compares the probiotic's effects against a placebo (a harmless pill with no active ingredients) to assess its impact on iron absorption and overall iron status. Women early in their pregnancy (10-16 weeks) with slightly low iron levels may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that Lactiplantibacillus plantarum 299v is likely to be safe for humans?
Research has shown that taking the probiotic Lactiplantibacillus plantarum 299v (LP299V®) during pregnancy is safe. Studies have found that this probiotic can improve iron levels in pregnant women and reduce the loss of iron stores, benefiting both mother and baby. Importantly, LP299V® is well-tolerated, with no serious side effects reported. Many pregnant women have used it without major issues. This probiotic may be a good choice for those seeking to maintain healthy iron levels during pregnancy.12345
Why do researchers think this study treatment might be promising?
Unlike traditional treatments for iron deficiency in pregnancy, which often involve iron supplements that can cause side effects like nausea and constipation, Lactiplantibacillus plantarum 299v (LP299V®) offers a novel approach. This probiotic works by enhancing iron absorption in the gut, potentially minimizing the need for high doses of iron supplements. Researchers are excited because LP299V® not only addresses iron deficiency but also supports gut health, offering a dual benefit that standard treatments don't provide.
What evidence suggests that Lactiplantibacillus plantarum 299v might be an effective treatment for iron deficiency in pregnancy?
Research has shown that the probiotic Lactiplantibacillus plantarum 299v (LP299V®), which participants in this trial may receive, can help improve iron levels in pregnant women. This probiotic aids the body in absorbing more iron from food, reducing the risk of iron deficiency anemia—a condition characterized by insufficient healthy red blood cells due to low iron. In one study, pregnant women who took LP299V® experienced a slower drop in their iron levels compared to those who did not take it. Another study found that including LP299V® with meals increased iron absorption by about 5%. Overall, LP299V® appears to be a promising way to boost iron levels during pregnancy.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive twice daily oral LP299V® supplementation from 10-16 weeks gestational age until the time of labor
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of neonatal iron status and neurodevelopment
What Are the Treatments Tested in This Trial?
Interventions
- Lactiplantibacillus plantarum 299v
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Probiotic
Placebo capsule
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
Citations
The effect of Lactiplantibacillus plantarum 299v together with a ...
Intake of Lp from early pregnancy was safe, attenuated the loss of iron stores and improved iron status in healthy pregnant women.
(PDF) The effect of Lactiplantibacillus plantarum 299v ...
LP299V® administration was shown to positively impact dietary iron bioavailability and reduce the prevalence of iron deficiency anemia early in pregnancy.
Feasibility Study of Lactobacillus Plantarum 299v Probiotic ...
A slower decline in maternal hematological and iron parameters across pregnancy was observed in the LP299V® group compared to placebo. (4) Conclusions: LP299V® ...
4.
news-medical.net
news-medical.net/news/20210421/Probiotic-strain-improves-iron-levels-in-healthy-pregnant-women.aspxProbiotic strain improves iron levels in healthy pregnant ...
(2021) The effect of Lactiplantibacillus plantarum 299v together with a low dose of iron on iron status in healthy pregnant women: A randomized ...
The Effect of Lactobacillus plantarum 299v on Iron Status and ...
Lp299v, together with 20 mg of iron, could result in a more substantial and rapid improvement in iron status and improved vigor compared to 20 mg of iron alone.
The effect of Lactiplantibacillus plantarum 299v together with a ...
Conclusions. Intake of Lp from early pregnancy was safe, attenuated the loss of iron stores and improved iron status in healthy pregnant women.
Improved iron status during pregnancy
The result showed that the women consuming Probi FerroSorb experienced a significantly lower decrease in serum ferritin, hemoglobin, and other ...
The effect of Lactiplantibacillus plantarum 299v together ...
Conclusions: Intake of Lp from early pregnancy was safe, attenuated the loss of iron stores and improved iron status in healthy pregnant women.
Probiotic Supplementation in Optimizing Iron and ...
This study is an essential first step toward evaluating if twice daily oral LP299V® is an efficacious, safe, inexpensive, and scalable clinical strategy for the ...
Feasibility Study of Lactobacillus Plantarum 299v Probiotic ...
A slower decline in maternal hematological and iron parameters across pregnancy was observed in the Lp299v® group compared to placebo. (4) ...
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