Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646487
Recruitment Status : Active, not recruiting
First Posted : August 24, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Mary Dawn Koenig, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 24, 2018
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE November 19, 2018
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
incidence of adherence to the supplement regimen [ Time Frame: 15 weeks gestation-delivery ]
number who adhere to the supplement regimen using Pillsy smart bottles and standard pill counts and overall withdrawal rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: 15 weeks gestation-delivery ]
    number of adverse events (AEs) (e.g., GI symptoms)
  • maternal hemoglobin [ Time Frame: 14 weeks gestation-delivery ]
    serum hemoglobin (g/dl)
  • maternal iron [ Time Frame: 14 weeks gestation-delivery ]
    serum iron (mcg/dL)
  • maternal ferritin [ Time Frame: 14 weeks gestation-delivery ]
    serum ferritin (ng/mL)
  • maternal transferrin [ Time Frame: 14 weeks gestation-delivery ]
    serum transferrin (mg/dL)
  • maternal transferrin receptor [ Time Frame: 14 weeks gestation-delivery ]
    serum transferrin receptor (mg/L)
  • maternal iron regulation [ Time Frame: 14 weeks gestation-delivery ]
    serum hepcidin (ng/ml)
  • infant hemoglobin (via cord blood) [ Time Frame: delivery ]
    serum hemoglobin (g/dl)
  • infant iron (via cord blood) [ Time Frame: delivery ]
    serum iron (mcg/dL)
  • infant ferritin (via cord blood) [ Time Frame: delivery ]
    serum ferritin (ng/mL)
  • infant transferrin (via cord blood) [ Time Frame: delivery ]
    serum transferrin (mg/dL)
  • infant transferrin receptor (via cord blood) [ Time Frame: delivery ]
    serum transferrin receptor (mg/L)
  • infant iron regulation (via cord blood) [ Time Frame: delivery ]
    serum hepcidin (ng/ml)
  • maternal stress response [ Time Frame: 14 weeks-39 weeks gestation ]
    serum 17-hydroxycorticosterone and hair cortisol via immunoassay
  • self report maternal perceived stress measured by the Perceived Stress Scale (PSS) [ Time Frame: 14 weeks-39 weeks gestation ]
    Perceived Stress Scale (PSS) is a 10-item scale intended to measure perceived stress over the last month. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: 15 weeks gestation-delivery ]
    number of adverse events (AEs) (e.g., GI symptoms)
  • maternal hemoglobin [ Time Frame: 14 weeks gestation-delivery ]
    serum hemoglobin (g/dl)
  • maternal iron [ Time Frame: 14 weeks gestation-delivery ]
    serum iron (mcg/dL)
  • maternal ferritin [ Time Frame: 14 weeks gestation-delivery ]
    serum ferritin (ng/mL)
  • maternal transferrin [ Time Frame: 14 weeks gestation-delivery ]
    serum transferrin (mg/dL)
  • maternal transferrin receptor [ Time Frame: 14 weeks gestation-delivery ]
    serum transferrin receptor (mg/L)
  • maternal iron regulation [ Time Frame: 14 weeks gestation-delivery ]
    serum hepcidin (ng/ml)
  • infant hemoglobin (via cord blood) [ Time Frame: delivery ]
    serum hemoglobin (g/dl)
  • infant iron (via cord blood) [ Time Frame: delivery ]
    serum iron (mcg/dL)
  • infant ferritin (via cord blood) [ Time Frame: delivery ]
    serum ferritin (ng/mL)
  • infant transferrin (via cord blood) [ Time Frame: delivery ]
    serum transferrin (mg/dL)
  • infant transferrin receptor (via cord blood) [ Time Frame: delivery ]
    serum transferrin receptor (mg/L)
  • infant iron regulation (via cord blood) [ Time Frame: delivery ]
    serum hepcidin (ng/ml)
  • maternal stress response [ Time Frame: 14 weeks-39 weeks gestation ]
    serum 17-hydroxycorticosterone and hair cortisol via immunoassay
  • self report maternal perceived stress [ Time Frame: 14 weeks-39 weeks gestation ]
    Perceived Stress Scale (PSS) is a 10-item scale intended to measure perceived stress over the last month. PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Black Women
Official Title  ICMJE Mitigating the Effects of Structural Violence on Maternal Iron Status: a Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Black Women
Brief Summary Maternal iron deficiency (ID) and adverse maternal-infant health outcomes disproportionately affect Black women. Chronic exposure to structural violence can dysregulate a Black woman's stress response promoting systemic inflammation. Stress-induced inflammation can negatively affect iron metabolism and promote ID that compromises the health of pregnant women and their infants - a phenomenon that may explain maternal-infant health disparities in Black women. Thus, interventions that can mitigate the physiologic effects of chronic stress have the potential to improve maternal-infant iron status that translates to positive maternal-infant health outcomes. There is evidence that the probiotic LP299v can reduce the adverse physiologic effects of stress and normalize iron metabolism although, this has not been tested in the context of pregnancy. The investigators will conduct a double blinded placebo-controlled randomized pilot study to determine the feasibility and tolerability of daily oral LP299v supplementation (15 weeks gestation - delivery) in 20 pregnant Black women from marginalized neighborhoods of Chicago and explore the effect of daily oral LP299v vs. placebo on maternal stress response and iron status, infant iron status at delivery, and molecular mechanisms (maternal microbiome) that may mediate the effect of LP299v on maternal stress- and iron-related outcomes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Iron-deficiency
  • Pregnancy, High Risk
  • Stress, Psychological
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Dietary Supplement: Probiotic LP299v 10x10 colony forming units in capsule form
  • Placebo Comparator: 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.
    Intervention: Other: Placebo in capsule form
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03646487
Other Study ID Numbers  ICMJE 2016-0662
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mary Dawn Koenig, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary Dawn D Koenig, PhD, RN, CNM University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP