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出境医 / 临床实验 / The FOUNDATION Study (FOUNDATION)

The FOUNDATION Study (FOUNDATION)

Study Description
Brief Summary:
The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.

Condition or disease Intervention/treatment Phase
Preterm Infant Other: B. infantis EVC001 Not Applicable

Detailed Description:
This is a single-center, open-label, prospective, cohort study of an infant probiotic (Food for Special Dietary Use) conducted in the neonatal intensive care unit (NICU). Each subject enrolled will be in the study from the time of consent (within 10 days of birth) to hospital discharge. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort. Infants in the B. infantis cohort will receive a daily feeding of B. infantis EVC001 in MCT oil until hospital discharge.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is a single-center, open-label, prospective, cohort study. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The FOUNDATION Study: Hospital Formulation Of B. Infantis EVC001 Utilized In The NICU To Demonstrate Tolerability In The Investigator's Preterm Neonates
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
Arm Intervention/treatment
No Intervention: Control
The Control Arm will not receive any study intervention or placebo. The infants in this arm will receive standard NICU care.
Active Comparator: B. infantis EVC001
Infants in the B. infantis arm will receive a once daily enteral feed of Evivo with MCT oil (8B CFU B. infantis EVC001) from Study Day 0 (by Day 10 of life) to hospital discharge, except on days when the infant is NPO.
 Other: B. infantis EVC001
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
Other Name: Evivo with MCT Oil
Outcome Measures
Primary Outcome Measures :
  1. Tolerability: Frequency of Adverse Events [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by Adverse Events. Frequency of treatment-emergent adverse events (TEAEs), serious TEAEs and TEAEs causing premature discontinuation will be provided by treatment group.

  2. Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by Probiotic Sepsis, as diagnosed by the PI. Frequency of Probiotic Sepsis will be provided by treatment group.

  3. Tolerability: Frequency of Blood in Stool [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by visualized frank blood in stool. Frequency of blood in stool will be provided by treatment group.

  4. Tolerability: Frequency of Abdominal Distension [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by abdominal distension causing treatment, diagnostics, or change in institutional standard of care. Frequency of abdominal distension will be provided by treatment group.

  5. Tolerability: Frequency of Emesis [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by significant or bilious emesis causing treatment, diagnostics, or change in institutional standard of care. Frequency of emesis will be provided by treatment group.

  6. Tolerability: Frequency of disruption in skin integrity in diaper area [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by disruption in skin integrity in diaper area requiring treatment. Frequency of disruption in skin integrity will be provided by treatment group.


Secondary Outcome Measures :
  1. B. infantis levels in preterm infant stool related to probiotic supplementation [ Time Frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age ]
    Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of B. infantis.

  2. Bifidobacterium levels in preterm infant stool related to probiotic supplementation [ Time Frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age ]
    Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of Bifidobacterium.

  3. Changes in the preterm gut microbiome over time related to probiotic supplementation [ Time Frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age ]
    Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA and RNA will be extracted from stool swab samples and will be used for next generation sequencing to determine relative abundance of the most abundant bacterial taxa.


Eligibility Criteria
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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Birth weight < 1500 grams or gestational age at birth < 33 and 0/7 weeks
  2. ≤ 10 days of life and considered viable
  3. Consuming exclusive human milk diet (mother's milk or donor milk) with or without fortifier at time of enrollment
  4. Toleration of 1.0 mL bolus enteral feeds

Exclusion Criteria:

  1. Presence of septicemia or active infection as determined by positive 48-hour blood cultures
  2. Necrotizing enterocolitis
  3. Pulmonary hypoplasia
  4. Presence of clinically significant congenital heart disease or other major congenital malformation
  5. Any infant the Investigator deems to be ineligible for participation
Contacts and Locations

Contacts
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Contact: Robin Flannery 530-747-2043 rflannery@evolvebiosystems.com

Locations
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United States, Florida
Orlando Health Winnie Palmer Hospital for Women & Babies Recruiting
Orlando, Florida, United States, 32806
Contact: Maxwell Corrigan, MS, MT-BC, NICU-MT    321-841-7816    Maxwell.Corrigan@orlandohealth.com   
Sponsors and Collaborators
Evolve BioSystems, Inc.
Investigators
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Principal Investigator: Sarah Bajorek, MD Orlando Health
Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date February 4, 2021
Actual Study Start Date  ICMJE July 3, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Tolerability: Frequency of Adverse Events [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by Adverse Events. Frequency of treatment-emergent adverse events (TEAEs), serious TEAEs and TEAEs causing premature discontinuation will be provided by treatment group.
  • Tolerability: Frequency of Probiotic Sepsis, as determined by the Principal Investigator [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by Probiotic Sepsis, as diagnosed by the PI. Frequency of Probiotic Sepsis will be provided by treatment group.
  • Tolerability: Frequency of Blood in Stool [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by visualized frank blood in stool. Frequency of blood in stool will be provided by treatment group.
  • Tolerability: Frequency of Abdominal Distension [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by abdominal distension causing treatment, diagnostics, or change in institutional standard of care. Frequency of abdominal distension will be provided by treatment group.
  • Tolerability: Frequency of Emesis [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by significant or bilious emesis causing treatment, diagnostics, or change in institutional standard of care. Frequency of emesis will be provided by treatment group.
  • Tolerability: Frequency of disruption in skin integrity in diaper area [ Time Frame: From the time of study product administration through study completion, which occurs at the time of hospital discharge. Anticipated length of stay for this patient population is up to 84 days. ]
    Tolerability of B. infantis EVC001 in preterm infants as determined by disruption in skin integrity in diaper area requiring treatment. Frequency of disruption in skin integrity will be provided by treatment group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • B. infantis levels in preterm infant stool related to probiotic supplementation [ Time Frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age ]
    Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of B. infantis.
  • Bifidobacterium levels in preterm infant stool related to probiotic supplementation [ Time Frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age ]
    Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA will be extracted from stool swab samples and will be used for quantitative PCR to determine levels of Bifidobacterium.
  • Changes in the preterm gut microbiome over time related to probiotic supplementation [ Time Frame: Baseline; Study Days 14 and 28; and 34, 36, and 38 weeks gestational age ]
    Effect of B. infantis EVC001 on the gut microbiome of preterm infants. DNA and RNA will be extracted from stool swab samples and will be used for next generation sequencing to determine relative abundance of the most abundant bacterial taxa.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The FOUNDATION Study
Official Title  ICMJE The FOUNDATION Study: Hospital Formulation Of B. Infantis EVC001 Utilized In The NICU To Demonstrate Tolerability In The Investigator's Preterm Neonates
Brief Summary The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.
Detailed Description This is a single-center, open-label, prospective, cohort study of an infant probiotic (Food for Special Dietary Use) conducted in the neonatal intensive care unit (NICU). Each subject enrolled will be in the study from the time of consent (within 10 days of birth) to hospital discharge. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort. Infants in the B. infantis cohort will receive a daily feeding of B. infantis EVC001 in MCT oil until hospital discharge.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
This is a single-center, open-label, prospective, cohort study. A prospective control cohort of 15 infants will initially be enrolled. Fifteen (15) infants will then be enrolled into the B. infantis cohort.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Preterm Infant
Intervention  ICMJE Other: B. infantis EVC001
Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
Other Name: Evivo with MCT Oil
Study Arms  ICMJE
  • No Intervention: Control
    The Control Arm will not receive any study intervention or placebo. The infants in this arm will receive standard NICU care.
  • Active Comparator: B. infantis EVC001
    Infants in the B. infantis arm will receive a once daily enteral feed of Evivo with MCT oil (8B CFU B. infantis EVC001) from Study Day 0 (by Day 10 of life) to hospital discharge, except on days when the infant is NPO.
    Intervention: Other: B. infantis EVC001
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Birth weight < 1500 grams or gestational age at birth < 33 and 0/7 weeks
  2. ≤ 10 days of life and considered viable
  3. Consuming exclusive human milk diet (mother's milk or donor milk) with or without fortifier at time of enrollment
  4. Toleration of 1.0 mL bolus enteral feeds

Exclusion Criteria:

  1. Presence of septicemia or active infection as determined by positive 48-hour blood cultures
  2. Necrotizing enterocolitis
  3. Pulmonary hypoplasia
  4. Presence of clinically significant congenital heart disease or other major congenital malformation
  5. Any infant the Investigator deems to be ineligible for participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 10 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robin Flannery 530-747-2043 rflannery@evolvebiosystems.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939546
Other Study ID Numbers  ICMJE EV-8801
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Evolve BioSystems, Inc.
Study Sponsor  ICMJE Evolve BioSystems, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarah Bajorek, MD Orlando Health
PRS Account Evolve BioSystems, Inc.
Verification Date February 2021

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

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