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Chondroitin Sulfate for NEC

Phase 1
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have a diagnosis of Bell's Stage 2 necrotizing enterocolitis
Be younger than 18 years old
Must not have
Previous history of NEC
History of abdominal surgery or other intestinal congenital anomalies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years post intervention

Summary

"This trial aims to test if chondroitin sulfate is safe and beneficial for newborns with necrotizing enterocolitis. Researchers will compare outcomes like mortality, need for surgery, and long-term

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a phase I trial primarily assessing safety, potential side effects of chondroitin sulfate in neonates with NEC are being investigated; however, detailed side effect profiles have not been specified here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Stage 2 necrotizing enterocolitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had NEC in the past.
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I have had abdominal surgery or was born with intestinal issues.
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I need dialysis due to kidney failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 years post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression to need for surgery
Secondary study objectives
Neurodevelopmental impairment (NDI)
Systemic inflammatory markers

Side effects data

From 2014 Phase 3 trial • 194 Patients • NCT01354145
44%
Infections and infestations
33%
Musculoskeletal and connective tissue disorders
28%
Gastrointestinal disorders
19%
Nasopharyngitis
19%
Injury, poisoning and procedural complications
14%
Respiratory, thoracic and mediastinal disorders
14%
Arthralgia
12%
Dyspepsia
12%
General disorders and administration site conditions
12%
Nervous system disorders
11%
Skin and subcutaneous tissue disorders
10%
Headache
9%
Psychiatric disorders
8%
Pain In Extremity
8%
Surgical and medical procedures
6%
Investigations
6%
Sinusitis
5%
Gastrooesophageal Reflux Disease
5%
Back Pain
5%
Vascular disorders
1%
Hip Surgery
1%
Cellulitis
1%
Diverticular Perforation
1%
Pneumonia
1%
Lobar Pneumonia
1%
Intestinal Obstruction
1%
Appendicitis
1%
Basal Cell Carcinoma
1%
Pulmonary Embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Celecoxib
Chondroitin Sulfate (Condrosan)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Chondroitin sulfateExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Neonates with Bell's Stage 2 NEC will receive 1-2 ml of milk or formula placebo for 2 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chondroitin sulfate
2011
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,035 Previous Clinical Trials
1,218,959 Total Patients Enrolled
~13 spots leftby Dec 2028
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