A Randomized Placebo Controlled Pilot Study of Probiotic... | NCT03646487

NCT03646487

ID	Type	Description	Link
5R34HL155481-03	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Description Module

Detailed Description

The most prevalent micronutrient deficiency in the United States (U.S.) is iron; a large majority of cases of iron deficiency (ID) and iron deficiency anemia (IDA) occur among pregnant women. During pregnancy, maternal iron stores are used for the growing fetus, maternal red blood cell (RBC) expansion, and placental growth and development, thus increasing the risk for ID and IDA. Across all trimesters of pregnancy in the U.S., it is estimated that 18% of individuals have ID and 5% have IDA, and within the third trimester, the prevalence of ID exceeds 27%. Prevalence of IDA is even greater among those who identify as Black or low-income. Maternal ID and IDA are associated with increased risk of preterm birth, low infant birth weight, maternal and fetal mortality, and irreversible infant neurocognitive defects. To meet this increasing requirement for iron and to optimize maternal iron nutrition, the Recommended Dietary Allowance for pregnancy is 27 mg/day of iron. However, given the continued high rates of maternal ID and IDA and only modest adherence to daily prenatal vitamins containing iron, alternative approaches to optimizing iron nutrition in pregnancy are needed.

Research has shown that one-time or short-term dosing of the probiotic Lactobacillus plantarum 299v (Lp299v) enhances iron absorption in non-pregnant populations. However, few studies have examined the effect of long-term supplementation on body iron stores. While probiotics are considered safe to consume in pregnancy, only one Lp299v supplementation trial has been conducted during the gestational period to evaluate its effects on maternal iron stores and risk of IDA. This study, among iron-sufficient pregnant Swedish women, showed a significantly lower decline in iron stores and a significantly lower prevalence of IDA in the third trimester among those randomized to Lp299v compared to standard care control.

These results offer potential positive effects for the role of Lp299v in maintaining maternal iron status among those starting pregnancy with sufficient iron stores and who receive care in a decentralized publicly funded healthcare system. However, no studies have evaluated the effect of Lp299v on maternal iron status among individuals at risk for IDA in pregnancy in the U.S., nor have studies extended findings to neonatal iron status. Moreover, it is unknown if positive feasibility and preliminary efficacy would persist in a U.S.-based health care setting with racially, ethnically, and socioeconomically diverse pregnant individuals. Therefore, the objectives of this study were as follows. First and foremost, we examined the feasibility of daily oral Lp299v maternal supplementation taken from the early second trimester through birth. Second, we explored the preliminary efficacy of Lp299v intake on maternal (at-risk for IDA defined as hemoglobin (Hb) between 10.0-12.0 g/dL) and neonatal cord hematological and iron status parameters compared to controls in an urban U.S. academic medical center with a racially, ethnically, and socioeconomically diverse patient population.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic LP299v	Experimental	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery.	Dietary Supplement: Probiotic LP299v 10x10 colony forming units in capsule form
Placebo	Placebo Comparator	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery.	Other: Placebo in capsule form

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic LP299v 10x10 colony forming units in capsule form	Dietary Supplement	Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form	Probiotic LP299v

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Adherence to the Supplement Regimen	Mean adherence to the supplement regimen using Pillsy smart bottles and standard pill counts.	15 weeks gestation through delivery, an average of 25 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Treatment-emergent Adverse Events Related to GI Symptoms	Adverse events were captured using the Maternal Adherence Form beginning with the first pill refill visit through delivery. number of participants reporting adverse GI events	15 weeks gestation through delivery, an average of 25 weeks
Maternal Hemoglobin

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Mary Dawn D Koenig, PhD, RN, CNM	University of Illinois at Chicago	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Illinois at Chicago		Chicago	Illinois	60612	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36839232	Result	OjiNjideka Hemphill N, Pezley L, Steffen A, Elam G, Kominiarek MA, Odoms-Young A, Kessee N, Hamm A, Tussing-Humphreys L, Koenig MD. Feasibility Study of Lactobacillus Plantarum 299v Probiotic Supplementation in an Urban Academic Facility among Diverse Pregnant Individuals. Nutrients. 2023 Feb 9;15(4):875. doi: 10.3390/nu15040875.

Label	URL
Feasibility Study of Lactobacillus Plantarum 299v Probiotic Supplementation in an Urban Academic Facility among Diverse Pregnant Individuals	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 4, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
BG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG0018 BG00220

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00029.0± 6.5 BG00128.7± 6.9 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00012 BG0018 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00012 BG0018 BG002

Relationship status

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Single not living with significant other	BG0005 BG0012 BG002

Health insurance

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Private	BG0006 BG0011 BG002

Education

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Some high school; some college	BG0009 BG0017 BG002

Household income

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
≤$30,999	BG0007 BG0017 BG002

Receiving public assistance

Number

participants

Title

Denominators

Categories

WIC (Women Infants and Children Program)

Title	Measurements
	BG0003 BG0012 BG002

Gestational age at baseline

Mean

Standard Deviation

weeks

Title

Denominators

Categories

Title	Measurements
	BG00012.6± 4.5 BG00113.7± 3.7 BG002

Gestational age at delivery

Mean

Standard Deviation

weeks

Title

Denominators

Categories

Title	Measurements
	BG00038.6± 0.7 BG00138.9± 0.7 BG002

Pre-pregnancy body mass index (BMI)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00031.1± 7.3 BG00131.8± 8.3 BG002

Pre-pregnancy obesity

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0007 BG0014 BG002

Maternal body mass index (BMI) at baseline

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00031.7± 6.8 BG00132.9± 6.8 BG002

Maternal obesity at baseline

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0008 BG0014 BG002

Parity

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
0	BG0005 BG0013 BG002

Food iron intake

Median

Inter-Quartile Range

mg/1000 kcal

Title

Denominators

Categories

Title	Measurements
	BG00011.2(9.4 to 11.9) BG001

Total iron (food and supplement) intake

Food iron intake was measured at baseline with a 24-hour diet recall (Nutrition Data System for Research (NDSR) software) using a multiple-pass interview approach, to standardize collection of the data. The consumption of dietary supplements was evaluated in concurrence with the 24-hour diet recall using the Dietary Supplement Assessment Module included in NDSR.

Median

Inter-Quartile Range

mg/1000 kcal

Title

Denominators

Categories

Title	Measurements
	BG00035.1(18.1 to 39.8) BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Adherence to the Supplement Regimen

Mean adherence to the supplement regimen using Pillsy smart bottles and standard pill counts.

A total of 20 participants were randomized in the study; n=12 in the Probiotic LP299v group and n=8 in the Placebo group. One participant in the Probiotic LP299v group completed the trial, but was not included in analysis because it was discovered the individual had alpha Thalassemia, a genetic disorder that impacts hemoglobin levels. Therefore, the overall number of participants analyzed in the Probiotic LP299v group was n=11.

Posted

Mean

Standard Deviation

percentage of adherence

15 weeks gestation through delivery, an average of 25 weeks

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants	OG00011 OG0018

Title

Denominators

Categories

Title	Measurements
	OG00067± 29.1 OG00180± 25.3

Secondary

Number of Treatment-emergent Adverse Events Related to GI Symptoms

Adverse events were captured using the Maternal Adherence Form beginning with the first pill refill visit through delivery. number of participants reporting adverse GI events

Posted

Number

GI events

15 weeks gestation through delivery, an average of 25 weeks

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Secondary

Maternal Hemoglobin

change in mean maternal serum hemoglobin (g/dl) from baseline to delivery

We analyzed participants who completed the study with ≥80% adherence to examine changes in maternal hematological and iron status parameters by randomization group.

Posted

Mean

95% Confidence Interval

g/dL

Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Secondary

Maternal Hematocrit

Change in mean maternal serum hematocrit (%) from baseline to delivery

We analyzed participants who completed the study with ≥80% adherence to examine changes in maternal hematological and iron status parameters by randomization group.

Posted

Mean

95% Confidence Interval

percentage by volume of red blood cells

Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Secondary

Maternal Iron

change in mean maternal serum iron (µg/dL) from baseline to delivery

We analyzed participants who completed the study with ≥80% adherence to examine changes in maternal hematological and iron status parameters by randomization group.

Posted

Mean

95% Confidence Interval

µg/dL

Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Secondary

Maternal Total Iron Binding Capacity

change in mean maternal total iron binding capacity (µmol/L) from baseline to delivery

We analyzed participants who completed the study with ≥80% adherence to examine changes in maternal hematological and iron status parameters by randomization group.

Posted

Mean

95% Confidence Interval

µmol/L

Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Secondary

Maternal Serum Ferritin

change in mean maternal serum ferritin (ng/mL) from baseline to delivery

We analyzed participants who completed the study with ≥80% adherence to examine changes in maternal hematological and iron status parameters by randomization group.

Posted

Mean

95% Confidence Interval

ng/mL

Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Secondary

Maternal Transferrin Saturation

change in mean maternal transferrin saturation (%) from baseline to delivery

We analyzed participants who completed the study with ≥80% adherence to examine changes in maternal hematological and iron status parameters by randomization group.

Posted

Mean

95% Confidence Interval

percentage of saturation

Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Secondary

Maternal High-sensitivity C-reactive Protein (Hs-CRP)

change in mean maternal high-sensitivity C-reactive protein (hs-CRP) (mg/L) from baseline to delivery

We analyzed participants who completed the study with ≥80% adherence to examine changes in maternal hematological and iron status parameters by randomization group.

Posted

Mean

95% Confidence Interval

mg/L

Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Secondary

Maternal Iron Deficiency Anemia

Number of participants who had iron deficiency anemia (IDA) at delivery. Hemoglobin, obtained from the Complete Blood Count, was used to define trimester-specific maternal IDA, with a downward correction of 0.8 g/dL for Black women. At the time of the study, it was recommended to use a race-adjusted cut-point for IDA. However, this race-adjusted cut-point was recently determined to be unfounded. IDA ranges included hemoglobin ≤11 g/dL for the first trimester, ≤10.5 g/dL for the second trimester, and ≤11 g/dL for the third trimester. IDA ranges with the correction for Black women were hemoglobin ≤10.2 g/dL for the first trimester, ≤9.7 g/dL for the second trimester, and ≤10.2 g/dL for the third trimester.

We analyzed participants who completed the study with ≥80% adherence to examine changes in maternal hematological and iron status parameters by randomization group.

Posted

Count of Participants

Participants

Assessed at baseline (i.e., 15-20 weeks gestation) through delivery; mean change from baseline to delivery is reported.

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo

Secondary

Infant Hemoglobin

Mean infant serum hemoglobin (g/dl) from cord blood at delivery.

The neonatal hematological and iron status parameters were examined for the newborns of mothers with ≥80% adherence to the supplement intervention.

Posted

Mean

95% Confidence Interval

g/dl

delivery

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants	OG000

Secondary

Infant Hematocrit

Mean infant serum hematocrit (%) from cord blood at delivery.

The neonatal hematological and iron status parameters were examined for the newborns of mothers with ≥80% adherence to the supplement intervention.

Posted

Mean

95% Confidence Interval

percentage by volume of red blood cells

delivery

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Secondary

Infant Iron

Mean infant serum iron (µg/dL) from cord blood at delivery.

The neonatal hematological and iron status parameters were examined for the newborns of mothers with ≥80% adherence to the supplement intervention.

Posted

Mean

95% Confidence Interval

µg/dL

delivery

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants	OG000

Secondary

Infant Total Iron Binding Capacity

Mean infant total iron binding capacity (µmol/L) from cord blood at delivery.

The neonatal hematological and iron status parameters were examined for the newborns of mothers with ≥80% adherence to the supplement intervention.

Posted

Mean

95% Confidence Interval

µmol/L

delivery

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Secondary

Infant Serum Ferritin

Mean infant serum ferritin (ng/mL) from cord blood at delivery.

The neonatal hematological and iron status parameters were examined for the newborns of mothers with ≥80% adherence to the supplement intervention.

Posted

Mean

95% Confidence Interval

ng/mL

delivery

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants	OG000

Secondary

Infant Transferrin Saturation

Mean infant transferrin saturation (%) from cord blood at delivery.

The neonatal hematological and iron status parameters were examined for the newborns of mothers with ≥80% adherence to the supplement intervention.

Posted

Mean

95% Confidence Interval

percentage of saturation

delivery

ID	Title	Description
OG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
OG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Probiotic LP299v	Women will receive 1 LP299v (10x10 colony forming units) in capsule form and 1 standard prenatal supplement in tablet form daily beginning at 15 weeks gestation through delivery. Probiotic LP299v 10x10 colony forming units in capsule form: Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form	0	11	0	11	9	11
EG001	Placebo	Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery. Placebo in capsule form: Daily placebo in capsule form	0	8	0	8	7	8

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Genitourinary conditions	Reproductive system and breast disorders	Non-systematic Assessment	Genitourinary Conditions include vaginal yeast infection, short cervix, trichomonas, continuous urinary tract infection, chlamydia, frequent urination, vaginitis, and 'white stuff in urine'.	EG0008 events4 affected11 at risk EG0015 events4 affected8 at risk
Gastrointestinal symptoms	Gastrointestinal disorders	Non-systematic Assessment	Gastrointestinal symptoms include abnormal oral glucose tolerance test, bloating, gassy, excessive stools, hemorrhoids, excessive saliva production, heart burn, nausea and food aversion.	EG0008 events8 affected11 at risk EG0019 events7 affected8 at risk
Upper respiratory conditions	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	Upper Respiratory Conditions include shortness of breath, cold, asthma, sore throat.	EG0001 events1 affected11 at risk EG0015 events5 affected8 at risk
Pain/swelling	General disorders	Non-systematic Assessment	Pain/Swelling includes back pain, round ligament pain, leg pain, carpal tunnel, and swelling.	EG0008 events4 affected11 at risk EG0017 events5 affected8 at risk
Headaches/migraines	General disorders	Non-systematic Assessment	Categories include conditions as denoted by name.	EG0003 events3 affected11 at risk EG0013 events3 affected8 at risk
Problems sleeping	General disorders	Non-systematic Assessment	Categories include conditions as denoted by name.	EG0004 events4 affected11 at risk EG0014 events4 affected8 at risk
Emergency room visits	General disorders	Non-systematic Assessment	Categories include conditions as denoted by name.	EG0002 events2 affected11 at risk EG0013 events3 affected8 at risk
Acne/rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	Categories include conditions as denoted by name.	EG0001 events1 affected11 at risk EG0011 events1 affected8 at risk
Anxiety/depression	Psychiatric disorders	Non-systematic Assessment	Categories include conditions as denoted by name.	EG0003 events2 affected11 at risk EG0010 events0 affected8 at risk
Fatigue/tired	General disorders	Non-systematic Assessment	Categories include conditions as denoted by name.	EG0005 events5 affected11 at risk EG0012 events2 affected8 at risk
Nosebleeds	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	Categories include conditions as denoted by name.	EG0000 events0 affected11 at risk EG0013 events3 affected8 at risk
Genetic iron diagnoses	Congenital, familial and genetic disorders	Non-systematic Assessment	Categories include conditions as denoted by name.	EG0001 events1 affected11 at risk EG0011 events1 affected8 at risk
Genetic fetal diagnoses	Congenital, familial and genetic disorders	Non-systematic Assessment	Categories include conditions as denoted by name.	EG0002 events2 affected11 at risk EG0010 events0 affected8 at risk
Other	General disorders	Non-systematic Assessment	Other includes 'feeling warm', dizziness, and eyesight changes.	EG0002 events1 affected11 at risk EG0012 events2 affected8 at risk

ID	Term
D018798	Anemia, Iron-Deficiency
D013315	Stress, Psychological

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000090463	Iron Deficiencies
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D001526	Behavioral Symptoms
D001519	Behavior

BG00210.5(8.3 to 12.6)

BG00236.2(18.5 to 38.6)

Units	Counts
Participants	OG00011 OG0018

Women will receive 1 placebo in capsule form and 1 standard prenatal supplement in table form daily beginning at 15 weeks gestation through delivery.

Placebo in capsule form: Daily placebo in capsule form