N/A
N=20
A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women
Iron-deficiency · Pregnancy, High Risk · Stress, Psychological
Bottom Line
View on ClinicalTrials.gov: NCT03646487 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Mean Adherence to the Supplement Regimen — 67; 80 percentage of adherence
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Probiotic LP299v 10x10 colony forming units in capsule form (Dietary_supplement); Placebo in capsule form (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Jul 2020
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 | — |
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.
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.