Necrotizing EnterocolitisPhase 1NCT01954017

STP206 for the Prevention of Necrotizing Enterocolitis (NEC)

A Phase 1 study testing STP206 in people with Necrotizing Enterocolitis, run by Leadiant Biosciences, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates. Read more about this study

Who is it for?: Ages 1 day to 4 days
Conditions the study is for: Necrotizing Enterocolitis
What is being tested?: STP206
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 103 participants
Where: 13 sitesUnited States
Study dates: 30 Jan 2014to 22 Oct 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 day to 4 days
All sexes
No healthy volunteers
Child

Who may be able to join

Neonates with birth weights between 2000-500g for Part A and 1500-500g for Part B
Ability to start treatment within four days after birth.
Gestational age between 23 and 32 weeks at birth
Obtaining of informed consent from the subject's mother after full understanding of the study purpose and procedures.
Parents who agree to allow the Principal Investigator and his/her staff to follow the procedures and assessments required by the protocol

Who cannot join

Infants with, or at high probability for, early onset sepsis (positive blood cultures or with clinical/histological chorioamnionitis with the expectation of empirical antimicrobial therapy for ≥5 days)
Infants with persistent pulmonary hypertension of the newborn (PPHN)
Congenital or chromosomal anomalies
Congenital or acquired gastrointestinal pathology that preclude feeds soon after birth (e.g. cleft lip is not an exclusion criterion, but a duodenal atresia is)
Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care)
Other conditions of the infant which, in the opinion of the attending neonatologist, preclude participation

Show all 10Show fewer

Positive maternal HIV status
Participation in another interventional clinical trial
For Part A of the study, the following additional exclusion criterion will apply:
Small for gestational age neonates, i.e. neonates that weigh less that the 10th percentile for their gestational age according to the Estimated Fetal Weight Percentile Chart

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Augusta University
Augusta, Georgia, 30912
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University South Carolina
Charleston, South Carolina, 29425
NorthShore University HealthSystem
Evanston, Illinois, 60201
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
University of Tennessee
Memphis, Tennessee, 38163
West Virginia University
Morgantown, West Virginia, 26506
The Medical Center of Plano
Plano, Texas, 75075
WakeMed Health and Hospitals
Raleigh, North Carolina, 27610
Southern Illinois University School of Medicine
Springfield, Illinois, 62769
Baystate Medical Center
Springfield, Massachusetts, 01199
Sheridan Clinical Research / Plantation General Hospital
Sunrise, Florida, 33323
Wesley Medical Center
Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: A Phase Ib Randomized, Placebo Controlled Study of the Safety and Efficacy of Once Daily Dosing of STP206 in Premature Very Low Birth Weight and Extremely Low Birth Weight Neonates

Read the detailed description

Protocol STP206-002 is designed as a multi-center, randomized, double-blind, placebo controlled dose escalation study of the safety and tolerability of two doses of STP206 versus control in four sequentially decreasing birth weight strata. The primary objective of this study is to assess the safety and tolerability of once daily dosing of two dose levels of STP206 versus control in four different birth weight strata in premature neonates. Secondary objectives of this study include assessment of fecal shedding of STP206 throughout dosing and describing the incidence of NEC, incidence of relevant clinical events (sepsis/bacteremia, feeding intolerance, morbidity/complications of prematurity) and neonatal growth progression in the STP206 and control treatment groups.

Neonates for whom informed consent is obtained and who meet eligibility criteria will be eligible to enroll in this study. All neonates enrolled will receive daily doses of blinded study treatment for between 2 and 11 weeks with the duration of dosing based upon gestational age at birth. All neonates enrolled in the study will be placed under Universal Precautions and all study personnel with subject contact are trained in appropriate neonatal intensive care unit (NICU) infection control practices. While in the NICU, neonates will be evaluated daily for signs/symptoms of NEC, feeding volumes/feeding tolerance, adverse events, and concomitant medications. Physical examinations and vital signs will be performed daily during the dosing period and at the end of dosing/NICU discharge. Growth assessments will be performed every other week while in the NICU and at the end of dosing/NICU discharge. Assessments for complications of prematurity, including retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), and bronchopulmonary dysplasia (BPD) will be performed at protocol defined timeframes. Neonates enrolled in the study will have fecal/meconium samples collected daily through 4 days following the start of dosing and weekly thereafter until NICU discharge to determine fecal shedding of STP6 and STP11. Following completion of blinded study treatment dosing, neonates will be evaluated at 1 week, 4 weeks, 3 months, and 6 months for safety and growth assessments.

Neonates will be stratified into the following four birth weights: 2000-1501g, 1500 to 1000 g, 999 to 750 g and 749 to 500 g. Each birth weight stratum will contain 2 dosing groups - a low dose STP206 group and a high dose STP206 group. Within each birth weight strata/dose level, subjects will be randomized in a 2:1 ratio to the STP206 or control group. Enrollment of neonates into study groups will occur sequentially. Enrollment into the high dose group within a birth weight stratum will not proceed until after the safety data from the low dose group is reviewed by the study independent Data Safety Monitoring Committee (DSMC). Similarly, enrollment into the next lower birth weight stratum will not proceed until the safety data from the high dose group of the prior weight stratum is reviewed by the study independent Data Safety Monitoring Committee (DSMC).

Conditions: Necrotizing Enterocolitis
Being tested: STP206, Control
Medical subject headings: Enterocolitis, Necrotizing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

STP206Biological
Live Biotherapeutic
ControlOther
Sterile Water

Study groups in NCT01954017
Study group	Role	What they receive
STP206	Experimental	Biological Receives: Biological: STP206
Control	Placebo comparator	Sterile water Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Measured: 30 days after the last dose of blinded study treatment
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Measured: 30 days after the last dose of blinded study treatment
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Measured: 30 days after last administration of study drug
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Measured: 30 days after last administration of study drug
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Grade 3 treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Measured: 30 days after last administration of study drug
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Grade 3 treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Measured: 30 days after last administration of study drug
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Serious adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Measured: 30 days after last administration of study drug
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Serious adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Measured: 30 days after last administration of study drug
Growth Assessment Classification in Low-Dose Treatment Groups
Accelerated growth area (AGA) is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.
Small for gestational age (SGA) SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.
SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.
Large for gestational age (LGA) is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.
Measured: End of dosing/hospital discharge, up to 781 days
Growth Assessment Classification in High-Dose Treatment Groups
AGA is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.
SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.
SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.
LGA is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.
Measured: End of dosing/hospital discharge, up to 781 days

Secondary outcomes (16)

Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Measured: Start of dosing to 6 months
Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Measured: Start of dosing to 6 months
Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Measured: Start of dosing to 6 months
Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups
NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).
Measured: Start of dosing to 6 months
Number of Patients With Sepsis in Low-Dose Treatment Groups
The presence of STP6 and STP11 was assessed in peripheral blood cultures.
Measured: Start of dosing to 6 months
Number of Patients With Sepsis in High-Dose Treatment Groups
The presence of STP6 and STP11 was assessed in peripheral blood cultures.
Measured: Start of dosing to 6 months
Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups
Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance.
Measured: Start of dosing to 6 months
Number of Patients With Feeding Intolerance in High-Dose Treatment Groups
Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance.
Measured: Start of dosing to 6 months
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment.
Measured: Start of dosing to 6 months
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment.
Measured: Start of dosing to 6 months
Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups
IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity.
Measured: From 5 days to 28 days
Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups
IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity.
Measured: From 5 days to 28 days
Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups
Mild to Moderate = Need for < 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first.
Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first.
For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events.
Measured: Start of dosing to 6 months
Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups
Mild to Moderate = Need for < 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first.
Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first.
For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events.
Measured: Start of dosing to 6 months
Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups
The presence of STP6 and STP11 was assessed in fecal cultures.
Measured: Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days
Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups
The presence of STP6 and STP11 was assessed in fecal cultures.
Measured: Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 201422 Oct 2018

First posted1 Oct 2013 (estimated)
Study start30 Jan 2014
Primary completion28 Feb 2018
Study completion22 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01954017
Sponsor's protocol ID: STP206-002
Status last verified: Mar 2020
First submitted: 18 Sep 2013
Last updated: 24 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)

All Necrotizing Enterocolitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Randomized, Placebo Controlled Study of the Safety and Efficacy of Once Daily Dosing of STP206 in Premature Very Low Birth Weight and Extremely Low Birth Weight Neonates
ClinicalTrials.gov ID: NCT01954017
Acronym / sponsor ID: STP206-002
Conditions: Necrotizing Enterocolitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Leadiant Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 30 Jan 2014 (actual)
Primary completion: 28 Feb 2018 (actual)
Study completion: 22 Oct 2018 (actual)
First posted: 1 Oct 2013 (estimated)
Results: Posted 24 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
STP206	Experimental	Biological: STP206Biological
Control	Placebo comparator	Other: ControlSterile water

Who may qualify

Ages: 1 day to 4 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Neonates with birth weights between 2000-500g for Part A and 1500-500g for Part B
Ability to start treatment within four days after birth.
Gestational age between 23 and 32 weeks at birth
Obtaining of informed consent from the subject's mother after full understanding of the study purpose and procedures.
Parents who agree to allow the Principal Investigator and his/her staff to follow the procedures and assessments required by the protocol

Key exclusion criteria (10 listed)

Infants with, or at high probability for, early onset sepsis (positive blood cultures or with clinical/histological chorioamnionitis with the expectation of empirical antimicrobial therapy for ≥5 days)
Infants with persistent pulmonary hypertension of the newborn (PPHN)
Congenital or chromosomal anomalies
Congenital or acquired gastrointestinal pathology that preclude feeds soon after birth (e.g. cleft lip is not an exclusion criterion, but a duodenal atresia is)
Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
STP206Live Biotherapeutic	Biological	STP206
ControlSterile Water	Other	Control

Primary outcome

Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups
Time frame: 30 days after the last dose of blinded study treatment
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Time frame: 30 days after the last dose of blinded study treatment
The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups
Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Time frame: 30 days after last administration of study drug
Treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Time frame: 30 days after last administration of study drug
Treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Time frame: 30 days after last administration of study drug
Grade 3 treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Time frame: 30 days after last administration of study drug
Grade 3 treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups
Time frame: 30 days after last administration of study drug
Serious adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug
Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups
Time frame: 30 days after last administration of study drug
Serious adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug
Growth Assessment Classification in Low-Dose Treatment Groups
Time frame: End of dosing/hospital discharge, up to 781 days
Accelerated growth area (AGA) is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Small for gestational age (SGA) SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Large for gestational age (LGA) is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.
Growth Assessment Classification in High-Dose Treatment Groups
Time frame: End of dosing/hospital discharge, up to 781 days
AGA is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. LGA is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.

16 secondary outcomes

Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Sepsis in Low-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Sepsis in High-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Feeding Intolerance in High-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups
Time frame: From 5 days to 28 days
Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups
Time frame: From 5 days to 28 days
Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups
Time frame: Start of dosing to 6 months
Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups
Time frame: Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days
Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups
Time frame: Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days

Results and safety

Results posted to the registry on 24 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose STP206	36	31
High Dose STP206	33	25
Control	34	21

Primary outcome: Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups

Time frame: 30 days after the last dose of blinded study treatment. Count of participants. Unit: Participants

Measure	Group 1a (Birth wt: 2000-1501 g) Low Dose n = 8	Group 1a (Birth wt: 2000-1501 g) Control n = 4	Group 2a (Birth wt: 1500-1000 g) Low Dose n = 9	Group 2a (Birth wt: 1500-1000 g) Control n = 4	Group 3a (Birth wt: 999-750 g) Low Dose n = 9	Group 3a (Birth wt: 999-750 g) Control n = 5	Group 4a (Birth wt: 749-500 g) Low Dose n = 8	Group 4a (Birth wt: 749-500 g) Control n = 4
Subjects with at least one treatment-emergent AE	7	4	7	3	9	5	8	4
Subjects with at least one treatment-related TEAE	0	0	0	0	1	0	0	0
Subjects with at least one TEAE Grade 3	1	1	0	0	1	2	3	1
Subjects with at least one related TEAE Grade 3	0	0	0	0	0	0	0	0
Subjects with TEAEs leading to stopping study drug	1	1	0	0	0	0	1	0
Subjects with at least one serious adverse event	1	1	1	0	3	2	5	1
Number of deaths	0	1	0	0	0	0	2	0

Population analysed: Safety population

Primary outcome: Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups

Time frame: 30 days after the last dose of blinded study treatment. Count of participants. Unit: Participants

Measure	Group 1b (Birth wt: 2000-1501 g) High Dose n = 8	Group 1b (Birth wt: 2000-1501 g) Control n = 4	Group 2b (Birth wt: 1500-1000 g) High Dose n = 8	Group 2b (Birth wt: 1500-1000 g) Control n = 4	Group 3b (Birth wt: 999-750 g) High Dose n = 8	Group 3b (Birth wt: 999-750 g) Control n = 4	Group 4b (Birth wt: 749-500 g) High Dose n = 8	Group 4b (Birth wt: 749-500 g) Control n = 4
Subjects with at least one treatment-emergent AE	5	4	7	3	7	3	8	4
Subjects with at least one treatment-related TEAE	0	0	2	0	1	0	0	0
Subjects with at least one TEAE Grade 3	1	0	0	0	2	1	1	3
Subjects with at least one related TEAE Grade 3	0	0	0	0	0	0	0	0
Subjects with TEAEs leading to stopping study drug	0	0	0	0	1	0	1	3
Subjects with at least one serious adverse event	1	0	1	0	2	1	4	4
Number of deaths	0	0	0	0	0	0	1	1

Population analysed: Safety population

Primary outcome: Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups

Time frame: 30 days after last administration of study drug. Count of participants. Unit: Participants

Measure	Group 1a (Birth wt: 2000-1501 g) Low Dose n = 8	Group 1a (Birth wt: 2000-1501 g) Control n = 4	Group 2a (Birth wt: 1500-1000 g) Low Dose n = 9	Group 2a (Birth wt: 1500-1000 g) Control n = 4	Group 3a (Birth wt: 999-750 g) Low Dose n = 9	Group 3a (Birth wt: 999-750 g) Control n = 5	Group 4a (Birth wt: 749-500 g) Low Dose n = 8	Group 4a (Birth wt: 749-500 g) Control n = 4
Blood: Anaemia neonatal	1	0	2	1	5	2	2	0
Blood: Anaemia	1	0	1	0	2	3	1	0
Blood: Thrombocytopenia	0	0	1	0	1	1	1	0
Cardiac: Foetal heart rate deceleration	1	1	0	0	0	0	0	0
Cardiac: Bradycardia	0	0	0	0	1	0	0	0
Cardiac: Cardio-respiratory arrest neonatal	0	0	0	0	0	1	0	0
Congenital: Ankyloglossia congenital	0	1	0	0	0	0	0	0
Congenital: Atrial septal defect	0	0	1	0	3	0	0	1

Population analysed: Safety population

Primary outcome: Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups

Time frame: 30 days after last administration of study drug. Count of participants. Unit: Participants

Measure	Group 1b (Birth wt: 2000-1501 g) High Dose n = 8	Group 2b (Birth wt: 1500-1000 g) High Dose n = 8	Group 3b (Birth wt: 999-750 g) High Dose n = 8	Group 3b (Birth wt: 999-750 g) Control n = 4	Group 4b (Birth wt: 749-500 g) High Dose n = 8	Group 4b (Birth wt: 749-500 g) Control n = 4
Blood: Anaemia neonatal	0	3	2	2	4	3
Blood: Anaemia	0	0	1	0	1	0
Blood: Thrombocytopenia	0	0	1	0	1	2
Blood: Coagulopathy	0	0	0	0	1	0
Blood: Leukocytosis	0	0	0	0	1	0
Cardiac: Foetal heart rate deceleration	0	1	0	0	0	0
Cardiac: Pulmonary valve stenosis	1	0	0	0	0	0
Cardiac: Supraventricuar tachycardia	1	0	0	0	0	0

Population analysed: Safety population

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months after last administration of study drug. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1a (Birth wt: 2000-1501 g) Low Dose	1 of 8 (12.5%)	7 of 8 (87.5%)	0 of 8
Group 1a (Birth wt:2000-1501 g) Control	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Group 2a (Birth wt:1500-1000 g) Low Dose	2 of 9 (22.2%)	7 of 9 (77.8%)	1 of 9
Group 2a (Birth wt:1500-1000 g) Control	2 of 4 (50%)	3 of 4 (75%)	0 of 4
Group 3a (Birth wt:999-750 g) Low Dose	3 of 9 (33.3%)	9 of 9 (100%)	0 of 9
Group 3a (Birth wt:999-750 g) Control	3 of 5 (60%)	5 of 5 (100%)	0 of 5
Group 4a (Birth wt: 749-500 g) Low Dose	5 of 8 (62.5%)	8 of 8 (100%)	2 of 8
Group 4a (Birth wt:749-500 g) Control	1 of 4 (25%)	4 of 4 (100%)	0 of 4
Group 1b (Birth wt: 2000-1501 g) High Dose	1 of 8 (12.5%)	6 of 8 (75%)	0 of 8
Group 1b (Birth wt:2000-1501 g) Control	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Group 2b (Birth wt: 1500-1000 g) High Dose	2 of 8 (25%)	7 of 8 (87.5%)	0 of 8
Group 2b (Birth wt:1500-1000 g) Control	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Group 3b (Birth wt: 999-750 g) High Dose	2 of 8 (25%)	7 of 8 (87.5%)	0 of 8
Group 3b (Birth wt:999-750 g) Control	1 of 4 (25%)	3 of 4 (75%)	0 of 4
Group 4b (Birth wt: 749-500 g) High Dose	4 of 8 (50%)	8 of 8 (100%)	1 of 8
Group 4b (Birth wt:749-500 g) Control	4 of 4 (100%)	4 of 4 (100%)	1 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael S Caplan, MD principal investigator

Endeavor Health

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing STP206 in people with Necrotizing Enterocolitis, run by Leadiant Biosciences, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups (time frame: 30 days after the last dose of blinded study treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01954017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.