CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Probiotic LP299v 10x10 colony forming units in capsule form +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03646487
NCT03646487N/ACompleted

"Pro-Moms" - Mitigating the Effects of Structural Violence on Maternal Iron Status: a Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women

University of Illinois at Chicago·interventional·Posted Aug 24, 2018·Updated Apr 7, 2023

In Brief

A clinical study evaluating Probiotic LP299v 10x10 colony forming units in capsule form and Placebo in capsule form for Iron-deficiency and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The goal of this randomized supplementation feasibility trial is to learn about the feasibility and preliminary efficacy of the probiotic, lactobacillus plantarum 299v (Lp299v), in pregnant individuals at-risk for iron deficiency anemia. The main questions it aims to answer are: * Is daily oral Lp299v a feasible and tolerable intervention for pregnant individuals to uptake? * Does daily oral Lp299v in pregnancy impact maternal and neonatal cord hematological and iron status parameters? Participants will be randomly assigned to one of two treatment groups: daily intake or probiotic Lp299v + prenatal vitamin with iron or placebo + prenatal vitamin with iron from 15-20 weeks of gestation through delivery. Researchers will compare the two treatment groups to see if there is a difference in the feasibility of the intervention and the preliminary efficacy on maternal and neonatal cord hematological and iron status parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 24, 2018
Enrollment StartNov 19, 2018
Primary CompletionJul 21, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.9 years ago

Interventions

Probiotic LP299v 10x10 colony forming units in capsule formdietary

Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form

Placebo in capsule formother

Daily placebo in capsule form