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A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women

NCT03646487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-07

Study results available
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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.

Conditions

  • Iron-deficiency
  • Pregnancy, High Risk
  • Stress, Psychological

Interventions

DIETARY_SUPPLEMENT

Probiotic LP299v 10x10 colony forming units in capsule form

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

OTHER

Placebo in capsule form

Daily placebo in capsule form

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Mary Dawn D Koenig, PhD, RN, CNM · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2020-07-21
Completion
2020-07-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646487 on ClinicalTrials.gov