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

NCT03646487 | Completed Results DMC

• 2 other identifiers: 2016-06625R34HL155481-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron-deficiency; Pregnancy, High Risk; Stress, Psychological

Keywords

pregnancy; iron status; structural violence

Outcome Measures

Primary Outcomes (1)

• 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 (15)

• Number of Treatment-emergent Adverse Events Related to GI Symptoms

  15 weeks gestation through delivery, an average of 25 weeks

• Maternal Hemoglobin

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

• Maternal Hematocrit

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

• Maternal Iron

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

• Maternal Total Iron Binding Capacity

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

Study Arms (2)

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

Probiotic LP299v 10x10 colony forming units in capsule form DIETARY_SUPPLEMENT

Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form

Probiotic LP299v

Placebo in capsule form OTHER

Daily placebo in capsule form

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 36839232 RESULT

Related Links

• Feasibility Study of Lactobacillus Plantarum 299v Probiotic Supplementation in an Urban Academic Facility among Diverse Pregnant Individuals

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Stress, Psychological

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Mary Dawn Koenig, PhD, RN, FACNM
• Organization: University of Illinois Chicago

marydh@uic.edu

312-996-7982

Study Officials

• Mary Dawn D Koenig, PhD, RN, CNM

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 24, 2018
• Study Start: November 19, 2018
• Primary Completion: July 21, 2020
• Study Completion: July 21, 2020
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)