<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03240419</url>
  </required_header>
  <id_info>
    <org_study_id>203392</org_study_id>
    <nct_id>NCT03240419</nct_id>
  </id_info>
  <brief_title>Prenatal Probiotic Intervention</brief_title>
  <official_title>Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the feasibility of a randomized control trial in which the effects of&#xD;
      probiotic supplementation throughout pregnancy on maternal insulin sensitivity and&#xD;
      inflammation, as well offspring gene expression and body composition are examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maternal obesity leads to increased insulin resistance and inflammation which have been shown&#xD;
      to induce fetal adaptations and greater risk of obesity in the offspring. Probiotic&#xD;
      supplementation during pregnancy has been shown to improve insulin sensitivity in normal&#xD;
      weight women. However, little is known on the effects of probiotic supplementation throughout&#xD;
      pregnancy on maternal insulin sensitivity and inflammation as well as offspring gene&#xD;
      expression and body composition. Long term nutritional supplementation, however, is&#xD;
      associated with increased participant burden as well as lower compliance and retention rates.&#xD;
      Thus, this study will assess the feasibility of a long term probiotic supplementation study&#xD;
      in obese pregnant women. Acceptance and compliance with daily capsules throughout pregnancy&#xD;
      and study procedures will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">March 26, 2019</completion_date>
  <primary_completion_date type="Actual">March 26, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in acceptance of probiotic supplementation throughout pregnancy in obese women.</measure>
    <time_frame>Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36</time_frame>
    <description>Participants will answer acceptability questionnaires in which they will have to rate (1= poor, 2= fair, 3= good, 4= very good, and 5= excellent ) their experience with capsule supplementation and study procedures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in compliance with probiotic supplementation throughout pregnancy in obese women.</measure>
    <time_frame>Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36</time_frame>
    <description>Change in compliance with capsule supplementation will be assessed during pregnancy via pill-count.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Childhood Obesity</condition>
  <condition>Maternal Obesity During Childbirth</condition>
  <condition>Insulin Resistance</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Probiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each probiotic capsule contains 180 mg of a standardized white to light beige fine powder consisting of freeze-dried cultures. Specifically, Bifidobacterium BB-12® and Lactobacillus rhamnosus LGG® (50%:50%). This product has a minimum potency of 6.5 billion (6.5E+9) CFU (ColonyForming Units) per capsule. Other ingredients in the powder are: microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate. Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in this group will take one capsule containing microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate (all ingredients listed in the probiotic capsules except the culture) . Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotics</intervention_name>
    <description>Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.</description>
    <arm_group_label>Probiotics</arm_group_label>
    <other_name>live cultures</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>capsule manufactured to mimic probiotic capsules.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 30&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Less than 12 weeks of gestation&#xD;
&#xD;
          -  Less than 1 serving of yoghurt with live cultures or cultured milk per week&#xD;
&#xD;
          -  Conceived without assisted fertility treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Women with pre-existing medical conditions (e.g., diabetes, hypertension, thyroid&#xD;
             disorders, heart disease or immune disorders) as determined by the PI to affect the&#xD;
             outcomes of interest&#xD;
&#xD;
               -  Immunosuppressed women&#xD;
&#xD;
               -  Women taking medications during pregnancy known to affect fetal growth (i.e.,&#xD;
                  thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents)&#xD;
&#xD;
               -  Women who are using recreational drugs, tobacco or alcohol during their pregnancy&#xD;
&#xD;
               -  Milk intolerance or allergy&#xD;
&#xD;
               -  Consuming probiotic supplements&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This study is on pregnant women.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva C Diaz Fuentes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arkansas Children's Nutrition Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://acnc.uams.edu/home/studies/</url>
    <description>Arkansas Children's Nutrition Center website</description>
  </link>
  <reference>
    <citation>Allen SJ, Jordan S, Storey M, Thornton CA, Gravenor M, Garaiova I, Plummer SF, Wang D, Morgan G. Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy. J Nutr. 2010 Mar;140(3):483-8. doi: 10.3945/jn.109.117093. Epub 2010 Jan 20.</citation>
    <PMID>20089774</PMID>
  </reference>
  <reference>
    <citation>Dugoua JJ, Machado M, Zhu X, Chen X, Koren G, Einarson TR. Probiotic safety in pregnancy: a systematic review and meta-analysis of randomized controlled trials of Lactobacillus, Bifidobacterium, and Saccharomyces spp. J Obstet Gynaecol Can. 2009 Jun;31(6):542-552. doi: 10.1016/S1701-2163(16)34218-9.</citation>
    <PMID>19646321</PMID>
  </reference>
  <reference>
    <citation>Ilmonen J, Isolauri E, Poussa T, Laitinen K. Impact of dietary counselling and probiotic intervention on maternal anthropometric measurements during and after pregnancy: a randomized placebo-controlled trial. Clin Nutr. 2011 Apr;30(2):156-64. doi: 10.1016/j.clnu.2010.09.009.</citation>
    <PMID>20970896</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Programming</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Maternal</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual participant data will be shared with other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03240419
org study id: 203392
nct id: NCT03240419
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess the feasibility of a randomized control trial in which the effects of
      probiotic supplementation throughout pregnancy on maternal insulin sensitivity and
      inflammation, as well offspring gene expression and body composition are examined.
Maternal obesity leads to increased insulin resistance and inflammation which have been shown
      to induce fetal adaptations and greater risk of obesity in the offspring. Probiotic
      supplementation during pregnancy has been shown to improve insulin sensitivity in normal
      weight women. However, little is known on the effects of probiotic supplementation throughout
      pregnancy on maternal insulin sensitivity and inflammation as well as offspring gene
      expression and body composition. Long term nutritional supplementation, however, is
      associated with increased participant burden as well as lower compliance and retention rates.
      Thus, this study will assess the feasibility of a long term probiotic supplementation study
      in obese pregnant women. Acceptance and compliance with daily capsules throughout pregnancy
      and study procedures will be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Change in acceptance of probiotic supplementation throughout pregnancy in obese women.
time frame: Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36
description: Participants will answer acceptability questionnaires in which they will have to rate (1= poor, 2= fair, 3= good, 4= very good, and 5= excellent ) their experience with capsule supplementation and study procedures.
measure: Change in compliance with probiotic supplementation throughout pregnancy in obese women.
time frame: Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36
description: Change in compliance with capsule supplementation will be assessed during pregnancy via pill-count.
arm group label: Probiotics
arm group type: Experimental
description: Each probiotic capsule contains 180 mg of a standardized white to light beige fine powder consisting of freeze-dried cultures. Specifically, Bifidobacterium BB-12® and Lactobacillus rhamnosus LGG® (50%:50%). This product has a minimum potency of 6.5 billion (6.5E+9) CFU (ColonyForming Units) per capsule. Other ingredients in the powder are: microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate. Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants in this group will take one capsule containing microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate (all ingredients listed in the probiotic capsules except the culture) . Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery.
intervention type: Dietary Supplement
intervention name: Probiotics
description: Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.
arm group label: Probiotics
other name: live cultures
intervention type: Dietary Supplement
intervention name: Placebo
description: capsule manufactured to mimic probiotic capsules.
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: This study is on pregnant women.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eva C Diaz Fuentes, MD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
url: https://acnc.uams.edu/home/studies/
description: Arkansas Children's Nutrition Center website
citation: Allen SJ, Jordan S, Storey M, Thornton CA, Gravenor M, Garaiova I, Plummer SF, Wang D, Morgan G. Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy. J Nutr. 2010 Mar;140(3):483-8. doi: 10.3945/jn.109.117093. Epub 2010 Jan 20.
PMID: 20089774
citation: Dugoua JJ, Machado M, Zhu X, Chen X, Koren G, Einarson TR. Probiotic safety in pregnancy: a systematic review and meta-analysis of randomized controlled trials of Lactobacillus, Bifidobacterium, and Saccharomyces spp. J Obstet Gynaecol Can. 2009 Jun;31(6):542-552. doi: 10.1016/S1701-2163(16)34218-9.
PMID: 19646321
citation: Ilmonen J, Isolauri E, Poussa T, Laitinen K. Impact of dietary counselling and probiotic intervention on maternal anthropometric measurements during and after pregnancy: a randomized placebo-controlled trial. Clin Nutr. 2011 Apr;30(2):156-64. doi: 10.1016/j.clnu.2010.09.009.
PMID: 20970896
responsible party type: Sponsor
mesh term: Obesity, Maternal
mesh term: Obesity
mesh term: Insulin Resistance
mesh term: Pediatric Obesity
mesh term: Inflammation
sharing ipd: No
ipd description: No individual participant data will be shared with other researchers.