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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK088027-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Emmaus Medical, Inc. | INDUSTRY |
| University of Michigan | OTHER |
| Emory University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Healthy Control | No Intervention | Healthy age-matched infants (n=12) will have serial stools collected on 4 occasions, each separated by 60 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine | Drug | 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Head Circumference | Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference | 6 months |
| Mid Arm Circumference | Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference. |
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Inclusion Criteria for Controls:
Exclusion Criteria for Controls:
Inclusion Criteria for Glutamine and Placebo Group of Short Bowel Syndrome (SBS) Patients:
Exclusion Criteria for Glutamine and Placebo Group of SBS Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Conrad R Cole, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.S. Mott Children's Hosptial | Ann Arbor | Michigan | 48109 | United States | ||
| Cincinnati Children's Hospital Medical Center |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glutamine | L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months) |
| FG001 | Placebo | L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months) |
| FG002 | Healthy Control | No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 Participant withdrew in the screening phase and did not randomize.
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| ID | Title | Description |
|---|---|---|
| BG000 | Glutamine | L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months) |
| BG001 | Placebo | L-Alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Two of the five participants analyzed completed the study. Healthy controls did not receive parenteral nutrition and were not analyzed in this outcome measure. | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glutamine | L-Glutamine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral Illness | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diaper Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Conrad R. Cole, MD | Cincinnati Children's Hospital Medical Center | 513-636-6155 | conrad.cole@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2014 | Apr 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012778 | Short Bowel Syndrome |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| D000409 | Alanine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| OTHER |
| University of Colorado, Denver | OTHER |
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| L-alanine | Dietary Supplement | 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months) |
|
| 6 months |
| Weight Velocity | Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity. | 6 months |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| BG002 | Healthy Control | No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Cause of Short Bowel Resection | Count of Participants | Participants |
|
| Birth Weight | Birth weight data was not obtained on healthy controls. | Mean | Full Range | kilograms |
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| Bowel Length | Healthy Controls did not have a bowel resection. | Mean | Full Range | Centimeters |
|
L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
|
|
| Primary | Length Velocity | Assess the efficacy of 6 months of therapy with enteral Glutamine on length velocity. | 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. | Posted | Mean | Full Range | Centimeters | 6 months |
|
|
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| Secondary | Head Circumference | Assess the efficacy of 6 months of therapy with enteral Glutamine on head circumference | 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. | Posted | Mean | Full Range | Centimeters | 6 months |
|
|
|
| Secondary | Mid Arm Circumference | Assess the efficacy of 6 months of therapy with enteral Glutamine on mid arm circumference. | 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. | Posted | Mean | Full Range | Centimeters | 6 months |
|
|
|
| Secondary | Weight Velocity | Assess the efficacy of 6 months of therapy with enteral Glutamine on weight velocity. | 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. | Posted | Mean | Full Range | Kilograms | 6 months |
|
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| 2 |
| 2 |
| EG001 | Placebo | L-alanine: 0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months) | 0 | 3 | 2 | 3 | 3 | 3 |
| EG002 | Healthy Control | No Intervention - Healthy age-matched infants provided stools on 4 occasions, each separated by 60 days. | 0 | 4 | 0 | 4 | 0 | 4 |
| Hospitalization for fever in a patient with a central line | Infections and infestations | Systematic Assessment |
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| Respiratory syncytial virus (RSV) | Infections and infestations | Systematic Assessment |
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| Sepsis | Blood and lymphatic system disorders | Systematic Assessment |
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| Otitis Media | Ear and labyrinth disorders | Systematic Assessment |
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| Vomiting | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| Central Venous Catheter (CVC) dislodged | General disorders | Systematic Assessment |
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| Rash Maculopapular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D021542 | Amino Acids, Neutral |
| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Length at Day 60 |
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| Length at Day 120 |
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| Length at Day 180 |
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| Head Circumference at Day 60 |
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| Head Circumference at Day 120 |
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| Head Circumference at day 180 |
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| Mid Arm Circumference at Day 60 |
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| Mid Arm Circumference at Day 120 |
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| Mid Arm Circumference at day 180 |
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| Weight at Day 60 |
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| Weight at Day 120 |
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| Weight at day 180 |
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