Working...
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03646487
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Mary Dawn Koenig, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Iron-deficiency Pregnancy, High Risk Stress, Psychological Dietary Supplement: Probiotic LP299v 10x10 colony forming units in capsule form Other: Placebo in capsule form Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Dietary Supplement: Probiotic LP299v 10x10 colony forming units in capsule form
Daily lactobacillus plantarum (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.
Other: Placebo in capsule form
Daily placebo in capsule form




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: 15 weeks gestation-delivery ]
    number of adverse events (AEs) (e.g., GI symptoms)

  2. maternal hemoglobin [ Time Frame: 14 weeks gestation-delivery ]
    serum hemoglobin (g/dl)

  3. maternal iron [ Time Frame: 14 weeks gestation-delivery ]
    serum iron (mcg/dL)

  4. maternal ferritin [ Time Frame: 14 weeks gestation-delivery ]
    serum ferritin (ng/mL)

  5. maternal transferrin [ Time Frame: 14 weeks gestation-delivery ]
    serum transferrin (mg/dL)

  6. maternal transferrin receptor [ Time Frame: 14 weeks gestation-delivery ]
    serum transferrin receptor (mg/L)

  7. maternal iron regulation [ Time Frame: 14 weeks gestation-delivery ]
    serum hepcidin (ng/ml)

  8. infant hemoglobin (via cord blood) [ Time Frame: delivery ]
    serum hemoglobin (g/dl)

  9. infant iron (via cord blood) [ Time Frame: delivery ]
    serum iron (mcg/dL)

  10. infant ferritin (via cord blood) [ Time Frame: delivery ]
    serum ferritin (ng/mL)

  11. infant transferrin (via cord blood) [ Time Frame: delivery ]
    serum transferrin (mg/dL)

  12. infant transferrin receptor (via cord blood) [ Time Frame: delivery ]
    serum transferrin receptor (mg/L)

  13. infant iron regulation (via cord blood) [ Time Frame: delivery ]
    serum hepcidin (ng/ml)

  14. maternal stress response [ Time Frame: 14 weeks-39 weeks gestation ]
    serum 17-hydroxycorticosterone and hair cortisol via immunoassay

  15. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • reside in Chicago zip codes: 60612, 60619, 60620, 60624, 60637, 60620, 60644, 60651, and 60636
  • a 1st trimester hemoglobin (Hb) of 10.0 - 11.5 g/dl demonstrating ID or risk for prenatal ID
  • singleton
  • naturally conceived pregnancy
  • < 15 weeks gestation
  • self identify as Black
  • 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:

  • live birth or another pregnancy in the previous 12 months
  • oral antibiotic use within the past 2 months
  • requiring a separate iron supplement beyond a standard prenatal vitamin
  • autoimmune disease
  • current or previous premature rupture of membranes/chorioamnionitis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646487


Contacts
Layout table for location contacts
Contact: Nefertiti Hemphill, MS (312) 355-3895 ojinjide@uic.edu
Contact: Mary Dawn Koenig, PhD, RN, CNM (312) 996-7942 marydh@uic.edu

Locations
Layout table for location information
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary Dawn Koenig, PhD, RN, CNM    312-996-7942    marydh@uic.edu   
Sub-Investigator: Lisa Tussing-Humphreys, PhD, RD, MS         
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Layout table for investigator information
Principal Investigator: Mary Dawn D Koenig, PhD, RN, CNM University of Illinois at Chicago

Layout table for additonal information
Responsible Party: Mary Dawn Koenig, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03646487     History of Changes
Other Study ID Numbers: 2016-0662
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Keywords provided by Mary Dawn Koenig, University of Illinois at Chicago:
pregnancy
iron status
structural violence

Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Iron-Deficiency
Stress, Psychological
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Behavioral Symptoms