Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

NCT01576003 | Completed Results DMC

• 2 other identifiers: 2010-27061R21DK088027-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bloodstream Infections; Short Bowel Syndrome; Development; Nutrition; Biological Markers

Keywords

Short Bowel Syndrome; Necrotizing Entercolitis (NEC); Atresia; Parenteral Nutrition; Biological Markers; Growth

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• Length Velocity

  Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity.

  6 months

Secondary Outcomes (3)

• Head Circumference

  6 months

• Mid Arm Circumference

  6 months

• Weight Velocity

  6 months

Study Arms (3)

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).

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).

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.

Interventions

Glutamine DRUG

0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)

Also known as: NutreStore

Glutamine

L-alanine DIETARY_SUPPLEMENT

0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)

L-alanine

Eligibility Criteria

• Age: 6 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Major congenital or chromosomal anomalies
• Inability to tolerate enteral nutrition/regular cow's milk, breast milk or formula
• History of liver/intestinal transplantation
• 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
• 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
• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Emmaus Medical, Inc.: collaborator
• University of Michigan: collaborator
• Emory University: collaborator
• University of Colorado, Denver: collaborator

Study Sites (2)

C.S. Mott Children's Hosptial

Ann Arbor, Michigan, 48109, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Sepsis; Short Bowel Syndrome; Hyperphagia

Interventions

Glutamine; Alanine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Limitations and Caveats

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.

Results Point of Contact

• Title: Conrad R. Cole, MD
• Organization: Cincinnati Children's Hospital Medical Center

conrad.cole@cchmc.org

513-636-6155

Study Officials

• Conrad R Cole, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-06

Locations

US (2)