Bloodstream InfectionsNCT01576003

Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

A study testing Glutamine and L-alanine in people with Bloodstream Infections and Short Bowel Syndrome, run by Children's Hospital Medical Center, Cincinnati at 2 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

Who is it for?: Ages 6 weeks to 12 monthsHealthy volunteers can take part
Conditions the study is for: Bloodstream Infections, Short Bowel Syndrome, Development
What is being tested?: Glutamine and L-alanine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 2 sitesUnited States
Study dates: Apr 2012to Jun 2015
Phase: Interventional
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 6 weeks to 12 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Less than or equal to 12 months of age
Normal small bowel length without any intestinal resection or primary intestinal disease
Not currently on Total Parenteral Nutrition (TPN) and if ever on TPN this should have been discontinued for at least 4 weeks.

Who cannot join

Major congenital or chromosomal anomalies
Inability to tolerate enteral nutrition/regular cow's milk, breast milk or formula
History of liver/intestinal transplantation
Inclusion Criteria for Glutamine and Placebo Group of Short Bowel Syndrome (SBS) Patients:
Less than or equal to 12 months of age
Patients who have undergone small bowel resection due to necrotizing enterocolitis (NEC) or intestinal atresia with known small bowel length

Show all 13Show fewer

Patients who have been Parenteral Nutrition (PN) dependent for more than 42 consecutive days and currently on TPN at time of enrollment
Patients who have the ability to take partial enteral nutrition or breast milk or elemental formula to allow the appropriate dose of glutamine or placebo
Signed informed consent for the use of Glutamine or placebo
Exclusion Criteria for Glutamine and Placebo Group of SBS Patients:
Major congenital or chromosomal anomalies
Inability to tolerate enteral nutrition that will preclude treatment with enteral Glutamine or L-alanine placebo for > 2 weeks
Liver/Intestinal transplantation

Trial locations and contacts

2 sites in 1 country.

United States2 sites

C.S. Mott Children's Hosptial
Ann Arbor, Michigan, 48109
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Efficacy of Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.

Read the detailed description

This is a double-blind, randomized placebo-controlled pilot study to investigate the efficacy of enteral glutamine (GLN) supplementation in 36 infants, ≤ 12 months of age with parenteral nutrition (PN)-dependent short bowel syndrome (SBS) due to massive small bowel resection for NEC and/or atresia on improving weaning of PN and preventing infections. The investigators intend to evaluate the effect of enteral feeding and GLN supplementation on the gut bacteria. The investigators will also recruit 12 age-matched controls to evaluate the normal gut bacteria.

Conditions: Bloodstream Infections, Short Bowel Syndrome, Development, Nutrition, Biological Markers
Being tested: Glutamine, L-alanine
Keywords: Short Bowel Syndrome, Necrotizing Entercolitis (NEC), Atresia, Parenteral Nutrition, Biological Markers, Growth
Medical subject headings: Sepsis, Short Bowel Syndrome, Hyperphagia

What participants receive

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

GlutamineDrug
Also called NutreStore
0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
L-alanineDietary supplement
0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)

Study groups in NCT01576003
Study group	Role	What they receive
Glutamine	Experimental	Infants randomized to the Glutamine group will receive L-Glutamine (GLN) administered enterally at a dose of 0.6g/kg body weight/day (0.3g/kg/dose) in 2 divided daily doses for 6 months. GLN will be dissolved in water, breast milk or formula and administered to the subject orally or through their enterostomy tube approximately every 12 hours (twice a day). Receives: Drug: Glutamine
L-alanine	Placebo comparator	Infants randomized to the placebo group will receive L-alanine (ALA) administered enterally at a dose of 0.6g/kg body weight/day in 2 divided doses (0.3g/kg/day twice a day) for 6 months. ALA will be dissolved in water, breast milk or formula and administered to the subject orally or through their enterostomy tube approximately every 12 hours (twice a day). Receives: Dietary Supplement: L-alanine
Healthy Control	No intervention	Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days.

What is being measured

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

Number of Participants With Bloodstream Infections (BSI)
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.
Measured: 6 months
Length Velocity
Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.
Measured: 6 months

Secondary outcomes (3)

Head Circumference
Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference
Measured: 6 months
Mid Arm Circumference
Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference.
Measured: 6 months
Weight Velocity
Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity.
Measured: 6 months

Timeline

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

Apr 2012Jun 2015

First posted12 Apr 2012 (estimated)
Study startApr 2012
Primary completionJun 2015
Study completionJun 2015

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 Bloodstream InfectionsStudies of the same condition, open and under way.
More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01576003
Sponsor's protocol ID: 2010-2706
Other IDs: 1R21DK088027-01A1
Status last verified: Jun 2020
First submitted: 10 Apr 2012
Last updated: 11 Jun 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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants
ClinicalTrials.gov ID: NCT01576003
Acronym / sponsor ID: 2010-2706
Conditions: Bloodstream Infections, Short Bowel Syndrome, Development, Nutrition, Biological Markers
Keywords: Short Bowel Syndrome, Necrotizing Entercolitis (NEC), Atresia, Parenteral Nutrition, Biological Markers, Growth
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emmaus Medical, Inc., University of Michigan, Emory University, University of Colorado, Denver
Study start: Apr 2012
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 12 Apr 2012 (estimated)
Results: Posted 11 Jun 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Glutamine	Experimental	Drug: GlutamineInfants randomized to the Glutamine group will receive L-Glutamine (GLN) administered enterally at a dose of 0.6g/kg body weight/day (0.3g/kg/dose) in 2 divided daily doses for 6 months. GLN will be dissolved in water, breast milk or formula and administered to the subject orally or through their enterostomy tube approximately every 12 hours (twice a day).
L-alanine	Placebo comparator	Dietary Supplement: L-alanineInfants randomized to the placebo group will receive L-alanine (ALA) administered enterally at a dose of 0.6g/kg body weight/day in 2 divided doses (0.3g/kg/day twice a day) for 6 months. ALA will be dissolved in water, breast milk or formula and administered to the subject orally or through their enterostomy tube approximately every 12 hours (twice a day).
Healthy Control	No intervention	–Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days.

Who may qualify

Ages: 6 weeks to 12 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Less than or equal to 12 months of age
Normal small bowel length without any intestinal resection or primary intestinal disease
Not currently on Total Parenteral Nutrition (TPN) and if ever on TPN this should have been discontinued for at least 4 weeks.

Key exclusion criteria (13 listed)

Major congenital or chromosomal anomalies
Inability to tolerate enteral nutrition/regular cow's milk, breast milk or formula
History of liver/intestinal transplantation
Inclusion Criteria for Glutamine and Placebo Group of Short Bowel Syndrome (SBS) Patients:
Less than or equal to 12 months of age

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
GlutamineAlso: NutreStore0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)	Drug	Glutamine
L-alanine0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)	Dietary supplement	L-alanine

Primary outcome

Number of Participants With Bloodstream Infections (BSI)
Time frame: 6 months
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.
Length Velocity
Time frame: 6 months
Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.

3 secondary outcomes

Head Circumference
Time frame: 6 months
Mid Arm Circumference
Time frame: 6 months
Weight Velocity
Time frame: 6 months

Results and safety

Results posted to the registry on 11 Jun 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
Glutamine	2	1
Placebo	3	1
Healthy Control	4	4

Primary outcome: Number of Participants With Bloodstream Infections (BSI)

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Glutamine n = 2	Placebo n = 3
Value	0	1

Population analysed: Two of the five participants analyzed completed the study. Healthy controls did not receive parenteral nutrition and were not analyzed in this outcome measure.

Primary outcome: Length Velocity

Time frame: 6 months. Mean (Full Range). Unit: Centimeters

Measure	Glutamine n = 2	Placebo n = 3
Length at Baseline	60.9 (56.7 to 65.0)	66.0 (63.2 to 70.8)
Length at Day 60	62.2	67.5 (63.6 to 71.4)
Length at Day 120	66.8	73.7
Length at Day 180	68	78.2

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glutamine	1 of 2 (50%)	2 of 2 (100%)	0 of 2
Placebo	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Healthy Control	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): Recruitment was low due to the improvement in care from the use of ethanol lock therapy and improved techniques related to line care. Early termination of participants lead to small number of subjects analyzed and inability to analyze all study aims.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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.

Conrad R Cole, MD principal investigator

Children's Hospital Medical Center, Cincinnati

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

Questions about this trial

What is this clinical trial studying?

A study testing Glutamine and L-alanine in people with Bloodstream Infections and Short Bowel Syndrome, run by Children's Hospital Medical Center, Cincinnati at 2 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 3 inclusion and 13 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 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 of Participants With Bloodstream Infections (BSI) (time frame: 6 months). The study lists 2 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 NCT01576003.

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 11 Jun 2020.