Chondroitin Sulfate for NEC

Overseen By Troy Markel, MD

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Indiana University

Disqualifiers: Severe cardiac anomalies, Renal failure, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

20 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What evidence supports the effectiveness of the drug chondroitin sulfate for treating NEC?

Chondroitin sulfate has shown anti-inflammatory and protective effects in other conditions, such as osteoarthritis and certain nervous system diseases, by reducing inflammation and protecting cells from damage. These properties might suggest potential benefits for treating NEC, which involves inflammation and tissue damage. ^{1 2 3 4 5}

Is Chondroitin Sulfate safe for humans?

The research articles provided do not contain specific safety data for Chondroitin Sulfate. However, they discuss the safety of polyethylene glycol (PEG), which is generally considered safe in humans, though there are rare cases of kidney issues. No adverse effects were found in children exposed to PEG over several decades. ^{6 7 8 9 10}

How is the drug chondroitin sulfate unique in treating NEC?

Chondroitin sulfate is unique because it has anti-inflammatory properties that may help reduce inflammation in tissues, which is a key factor in NEC (necrotizing enterocolitis). Unlike other treatments, it also interacts with various proteins and growth factors, potentially aiding in tissue repair and reducing inflammation. ^{3 11 12 13 14}

What is the purpose of this trial?

The goal of this phase 1 double blind, randomized controlled trial is to determine the safety of chondroitin sulfate supplementation in the neonates with necrotizing enterocolitis. The main questions the study aims to answer are: Is chondroitin sulfate safe to administer in the neonatal NEC population, and will it have a beneficial profile in the short term intestinal and long term neurodevelopmental sequelae of NEC? Researchers will compare all cause mortality, progression to surgery, systemic inflammatory markers, and long term neurodevelopmental outcomes in those NEC patients who receive chondroitin sulfate compared to those who receive milk or formula placebo.

Eligibility Criteria

This trial is for newborns with a serious intestinal condition called necrotizing enterocolitis (NEC). The study will include those who meet specific health criteria, but the exact inclusion and exclusion details are not provided here.

Inclusion Criteria

NICU patient at Riley Hospital for Children

Weight of less than 2500g at time of NEC diagnosis

I have been diagnosed with Stage 2 necrotizing enterocolitis.

Exclusion Criteria

I do not have any severe illness that would make me unsuitable for treatment.

Severe cardiac or neurological congenital anomalies

I have had NEC in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Neonates with Bell's Stage 2 NEC receive chondroitin sulfate or placebo for 2 days

2 days

Daily administration

Short-term Follow-up

Participants are monitored for progression to surgery and systemic inflammatory markers

4 weeks

Regular monitoring

Long-term Follow-up

Neurodevelopmental outcomes are assessed at 1 and 2 years post intervention

2 years

Treatment Details

Interventions

• Chondroitin Sulfate

Trial Overview The trial is testing if chondroitin sulfate is safe for treating NEC in newborns. It's a phase 1 study where some babies will get chondroitin sulfate and others a milk or formula placebo to compare outcomes like survival, need for surgery, inflammation levels, and long-term brain development.

Participant Groups

Group I: Chondroitin sulfate Experimental Treatment 1 Intervention

Neonates with Bell's Stage 2 NEC will receive chondroitin sulfate (20mg/kg/day) dissolved in 1-2 mil of milk or formula for 2 days

Group II: Placebo Placebo Group 1 Intervention

Neonates with Bell's Stage 2 NEC will receive 1-2 ml of milk or formula placebo for 2 days

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Findings from Research

A 3-month study involving 96 constipated children aged 6 months to 3 years demonstrated that polyethylene glycol (PEG) 4000 is safe and well-tolerated, with no significant treatment-related changes in blood parameters compared to lactulose.

PEG 4000 showed greater improvements in stool consistency, appetite, and reduced need for additional laxatives compared to lactulose, indicating its efficacy in treating pediatric constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. Dupont, C., Leluyer, B., Maamri, N., et al.[2022]

A study estimated PEG exposure in children receiving PEGylated therapies for hemophilia, revealing significant annual exposure levels without any reported adverse effects, suggesting long-term safety.

For a 50 kg child on the highest prophylactic dose of FVIII, PEG exposure ranged from 40 to 21,840 mg/year, yet no adverse event patterns related to PEG were identified, indicating that PEG is likely safe for pediatric use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol Exposure with Antihemophilic Factor (Recombinant), PEGylated (rurioctocog alfa pegol) and Other Therapies Indicated for the Pediatric Population: History and Safety. Stidl, R., Denne, M., Goldstine, J., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Antioxidant, antiinflammatory and neuroprotective actions of chondroitin sulfate and proteoglycans. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A highly sulfated chondroitin sulfate preparation, CS-E, prevents excitatory amino acid-induced neuronal cell death. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Immunomodulatory and anti-inflammatory effects of chondroitin sulphate. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Enzymatic Synthesis of Chondroitin Sulfate E to Attenuate Bacteria Lipopolysaccharide-Induced Organ Damage. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Design of chondroitin sulfate-based polyelectrolyte nanoplexes: Formation of nanocarriers with chitosan and a case study of salmon calcitonin. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol Exposure with Antihemophilic Factor (Recombinant), PEGylated (rurioctocog alfa pegol) and Other Therapies Indicated for the Pediatric Population: History and Safety. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of toxicity and tolerability of a combination vehicle; 5% Pharmasolve, 45% Propylene glycol and 50% Polyethylene glycol 400 in rats following repeated intravenous administration. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Renal cortical necrosis following a colonoscopy. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Chondroitin: a natural biomarker with immense biomedical applications. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Purification of chondroitin 6-sulfotransferase secreted from cultured chick embryo chondrocytes. [2023]

13. England pubmed.ncbi.nlm.nih.gov

The potential of chondroitin sulfate as a therapeutic agent. [2008]

14. United States pubmed.ncbi.nlm.nih.gov

Interaction of chondroitin sulfate and dermatan sulfate from various biological sources with heparin-binding growth factors and cytokines. [2021]