Trial Outcomes & Findings for Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants (NCT NCT01576003)
NCT ID: NCT01576003
Last Updated: 2020-06-11
Results Overview
Evaluate the efficacy of enteral Glutamine supplementation to decrease bloodstream infections in participants that are parenteral nutrition dependent with Short Bowel Syndrome due to necrotizing enterocolitis (NEC) and/or atresia.
COMPLETED
NA
10 participants
6 months
2020-06-11
Participant Flow
One participant consented and then withdrew prior completing any study procedure. This participant is not included in the participant flow due to the fact no study procedures or randomization occurred.
Participant milestones
| Measure |
Glutamine
L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Placebo
L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
|
Healthy Control
No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
4
|
|
Overall Study
COMPLETED
|
1
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Birth weight data was not obtained on healthy controls.
Baseline characteristics by cohort
| Measure |
Glutamine
n=2 Participants
L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Placebo
n=3 Participants
L-Alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Healthy Control
n=4 Participants
No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
6 weeks through 2 months
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Age, Customized
3 months through 4 months
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Age, Customized
5 months through 6 months
|
1 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Age, Customized
7 months through 8 months
|
1 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Age, Customized
9 months through 10 months
|
0 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Age, Customized
11 months through 12 months
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Cause of Short Bowel Resection
Atresia
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Cause of Short Bowel Resection
Necrotizing enterocolitis (NEC)
|
1 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Cause of Short Bowel Resection
NEC and Atresia
|
0 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Birth Weight
|
2.4 kilograms
n=2 Participants • Birth weight data was not obtained on healthy controls.
|
2.6 kilograms
n=3 Participants • Birth weight data was not obtained on healthy controls.
|
—
|
2.35 kilograms
n=5 Participants • Birth weight data was not obtained on healthy controls.
|
|
Bowel Length
|
49.5 Centimeters
n=2 Participants • Healthy Controls did not have a bowel resection.
|
82.0 Centimeters
n=3 Participants • Healthy Controls did not have a bowel resection.
|
—
|
69.0 Centimeters
n=5 Participants • Healthy Controls did not have a bowel resection.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Two of the five participants analyzed completed the study. Healthy controls did not receive parenteral nutrition and were not analyzed in this outcome measure.
Evaluate the efficacy of enteral Glutamine supplementation to decrease bloodstream infections in participants that are parenteral nutrition dependent with Short Bowel Syndrome due to necrotizing enterocolitis (NEC) and/or atresia.
Outcome measures
| Measure |
Glutamine
n=2 Participants
Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Placebo
n=3 Participants
L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
|
|---|---|---|
|
Number of Participants With Bloodstream Infections (BSI)
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The number analyzed at Baseline and days 60, 120 and 180 differ from the overall number analyzed due protocol noncompliance and participant request to withdrawal from the protocol. Healthy controls were not analyzed in this outcome measure because they did not receive parenteral nutrition, L-Glutamine or placebo.
Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.
Outcome measures
| Measure |
Glutamine
n=2 Participants
Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Placebo
n=3 Participants
L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
|
|---|---|---|
|
Length Velocity
Length at Baseline
|
60.9 Centimeters
Interval 56.7 to 65.0
|
66.0 Centimeters
Interval 63.2 to 70.8
|
|
Length Velocity
Length at Day 180
|
68 Centimeters
|
78.2 Centimeters
|
|
Length Velocity
Length at Day 60
|
62.2 Centimeters
|
67.5 Centimeters
Interval 63.6 to 71.4
|
|
Length Velocity
Length at Day 120
|
66.8 Centimeters
|
73.7 Centimeters
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number analyzed at Baseline and days 60, 120 and 180 differ from the overall number analyzed due protocol noncompliance and participant request to withdrawal from the protocol. Healthy controls were not analyzed in this outcome measure because they did not receive parenteral nutrition, L-Glutamine or placebo.
Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference
Outcome measures
| Measure |
Glutamine
n=2 Participants
Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Placebo
n=3 Participants
L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
|
|---|---|---|
|
Head Circumference
Head Circumference at Baseline
|
42.9 Centimeters
Interval 41.1 to 44.8
|
43.8 Centimeters
Interval 42.2 to 46.8
|
|
Head Circumference
Head Circumference at Day 60
|
43.5 Centimeters
|
43.4 Centimeters
Interval 42.0 to 44.8
|
|
Head Circumference
Head Circumference at Day 120
|
48.8 Centimeters
|
46 Centimeters
|
|
Head Circumference
Head Circumference at day 180
|
44.5 Centimeters
|
46.6 Centimeters
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number analyzed at Baseline and days 60,120 and 180 differ from the overall number analyzed due protocol noncompliance and participant request to withdrawal from the protocol. Healthy controls were not analyzed in this outcome measure because they did not receive parenteral nutrition, L-Glutamine or placebo.
Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference.
Outcome measures
| Measure |
Glutamine
n=2 Participants
Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Placebo
n=3 Participants
L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
|
|---|---|---|
|
Mid Arm Circumference
Mid Arm Circumference at Baseline
|
13 Centimeters
Interval 10.9 to 15.0
|
16.0 Centimeters
Interval 16.0 to 16.0
|
|
Mid Arm Circumference
Mid Arm Circumference at Day 60
|
12.6 Centimeters
|
16.0 Centimeters
Interval 15.8 to 16.3
|
|
Mid Arm Circumference
Mid Arm Circumference at Day 120
|
12.5 Centimeters
|
8.8 Centimeters
|
|
Mid Arm Circumference
Mid Arm Circumference at day 180
|
12.8 Centimeters
|
17.3 Centimeters
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number analyzed at Baseline and days 60, 120 and 180 differ from the overall number analyzed due protocol noncompliance and participant request to withdrawal from the protocol. Healthy controls were not analyzed in this outcome measure because they did not receive parenteral nutrition, L-Glutamine or placebo.
Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity.
Outcome measures
| Measure |
Glutamine
n=2 Participants
Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Placebo
n=3 Participants
L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
|
|---|---|---|
|
Weight Velocity
Weight at Day 60
|
6.4 Kilograms
|
8.4 Kilograms
Interval 7.8 to 9.0
|
|
Weight Velocity
Weight at Day 120
|
7.1 Kilograms
|
9.3 Kilograms
|
|
Weight Velocity
Weight at day 180
|
7.9 Kilograms
|
9.4 Kilograms
|
|
Weight Velocity
Weight at Baseline
|
6.5 Kilograms
Interval 5.2 to 7.9
|
8.1 Kilograms
Interval 7.6 to 9.2
|
Adverse Events
Glutamine
Placebo
Healthy Control
Serious adverse events
| Measure |
Glutamine
n=2 participants at risk
L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Placebo
n=3 participants at risk
L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Healthy Control
n=4 participants at risk
No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.
|
|---|---|---|---|
|
Infections and infestations
Viral Illness
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Infections and infestations
Hospitalization for fever in a patient with a central line
|
50.0%
1/2 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Infections and infestations
Respiratory syncytial virus (RSV)
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Blood and lymphatic system disorders
Sepsis
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
Other adverse events
| Measure |
Glutamine
n=2 participants at risk
L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Placebo
n=3 participants at risk
L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
|
Healthy Control
n=4 participants at risk
No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Diaper Dermatitis
|
0.00%
0/2 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Ear and labyrinth disorders
Otitis Media
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
General disorders
Vomiting
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
General disorders
Central Venous Catheter (CVC) dislodged
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
Additional Information
Conrad R. Cole, MD
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place