N/A
Completed N=20
A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women
Iron Deficiency · Pregnancy, High Risk · Stress, Psychological
Source: ClinicalTrials.gov NCT03646487 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Mean Adherence to the Supplement Regimen — 67; 80 percentage of adherence
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Adherence to the Supplement Regimen |
67; 80 | — |
| SECONDARY Number of Treatment-emergent Adverse Events Related to GI Symptoms |
8; 9 | — |
| SECONDARY Maternal Hemoglobin |
0.4; -0.1 | — |
| SECONDARY Maternal Hematocrit |
-0.03; -0.5 | — |
| SECONDARY Maternal Iron |
-5.2; 5.7 | — |
| SECONDARY Maternal Total Iron Binding Capacity |
89.4; 58.3 | — |
| SECONDARY Maternal Serum Ferritin |
-4.4; 0 | — |
| SECONDARY Maternal Transferrin Saturation |
-6.2; -1.7 | — |
| SECONDARY Maternal High-sensitivity C-reactive Protein (Hs-CRP) |
-0.04; -3.0 | — |
| SECONDARY Maternal Iron Deficiency Anemia |
1; 2 | — |
| SECONDARY Infant Hemoglobin |
14.7; 16.4 | — |
| SECONDARY Infant Hematocrit |
44.3; 49.5 | — |
| SECONDARY Infant Iron |
136.2; 108.0 | — |
| SECONDARY Infant Total Iron Binding Capacity |
223.6; 274.0 | — |
| SECONDARY Infant Serum Ferritin |
88.8; 88.0 | — |
| SECONDARY Infant Transferrin Saturation |
63.8; 43.3 | — |
Eligibility Criteria
Inclusion Criteria
- a 1st trimester hemoglobin (Hb) of 10.0 - 11.9 g/dl demonstrating ID or risk for prenatal ID
- singleton
- naturally conceived pregnancy
- < 20 weeks gestation
- 18 - 45 years of age
- sufficient fluency in English to complete study forms
- refrain from non-study dietary and pre-/probiotic supplements while enrolled in the study
Exclusion Criteria
- oral antibiotic use within the past 2 months
- autoimmune disease
- infection
- receiving steroid treatment
- bariatric surgery
- inflammatory bowel disease
- hyperemesis
- hematologic disorder (e.g., sickle cell disease)
- current tobacco use
- substance abuse in the last 6 months
- other chronic disorders such as type 2 diabetes
Data sourced from ClinicalTrials.gov (NCT03646487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.