Chondroitin Sulfate for NEC
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of chondroitin sulfate for newborns with necrotizing enterocolitis (NEC), a serious intestinal condition. Researchers aim to determine if this supplement can address immediate gut issues and future brain development problems associated with NEC. Babies in the trial will receive either chondroitin sulfate mixed with milk or formula, or just milk or formula as a placebo. The trial seeks infants in the NICU at Riley Hospital for Children who weigh less than 2500 grams and have Bell's Stage 2 NEC. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking treatment.
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.
Is there any evidence suggesting that chondroitin sulfate is likely to be safe for neonates with NEC?
Studies have shown that chondroitin sulfate, when tested in animals, reduced intestinal injury and improved weight gain. For humans, current research does not clearly establish safety information. However, the FDA has approved chondroitin sulfate for other uses, suggesting it might generally be safe. This early-phase trial primarily aims to determine if the supplement is safe for newborns with necrotizing enterocolitis (NEC). Early-phase trials often focus on safety and may not yet provide extensive information on side effects in humans.12345
Why do researchers think this study treatment might be promising for NEC?
Unlike the standard treatments for necrotizing enterocolitis (NEC), which often involve antibiotics or surgical interventions, chondroitin sulfate presents a unique approach. This treatment is derived from chondroitin sulfate, a compound naturally found in the cartilage around joints, and is administered directly through milk or formula. Researchers are excited because chondroitin sulfate might offer a gentler, non-invasive option that targets the inflammation and tissue damage at the core of NEC, potentially leading to faster recovery in neonates with fewer side effects.
What evidence suggests that chondroitin sulfate might be an effective treatment for NEC?
Research has shown that chondroitin sulfate might improve outcomes for necrotizing enterocolitis (NEC), a serious intestinal condition. In animal studies, such as those with mice, chondroitin sulfate has been linked to better weight gain, less severe illness, and reduced intestinal damage. One study found that adding chondroitin sulfate to baby formula improved health outcomes compared to no treatment for NEC. In this trial, some neonates with Bell's Stage 2 NEC will receive chondroitin sulfate, while others will receive a placebo. These findings suggest that chondroitin sulfate could be beneficial in managing NEC in humans, but more research is needed to confirm its effectiveness in newborns.15678
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Neonates with Bell's Stage 2 NEC receive chondroitin sulfate or placebo for 2 days
Short-term Follow-up
Participants are monitored for progression to surgery and systemic inflammatory markers
Long-term Follow-up
Neurodevelopmental outcomes are assessed at 1 and 2 years post intervention
What Are the Treatments Tested in This Trial?
Interventions
- Chondroitin Sulfate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor