Clinical Trials for Enterocolitis

Clinical trials are research studies conducted in an effort to improve overall patient health and care. Each trial involves running supervised tests to determine the effectiveness and safety of new drugs, procedures and/or devices with the aim of answering scientific questions about a disease or condition. Risks and side-effects are also evaluated during these trials with results ranging from being unpleasant, with side effects such as headaches, to more serious or even life-threatening risks. A clinical trial may be separated into phases, or steps, with each step designed to answer a separate research question. This maybe reflected in the trial name.

A brief description of each phase:

• Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients.
• Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety.
• Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety.
• Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

Clinical Trials data for Enterocolitis is grouped into the following categories:-

• View by trial name
• View by drugs used in Enterocolitis clinical trials

Clinical Trials by trial name

The format for each of the following is:

• The name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.
• followed by a list of drug/s, if any, used in the trial

ClinicalTrials.gov has listed the following trials for Enterocolitis:

• Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment - This study has been completed (Current: 23 Nov 2006) - Metronidazole and Rifampin
• Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis - This study is currently recruiting patients (Current: 23 Nov 2006)
• Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants - This study has been completed (Current: 23 Nov 2006)
• Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants - This study has been completed (Current: 23 Nov 2006)
• A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea - This study has been completed (Current: 23 Nov 2006) - GT160-246
• A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea - This study is currently recruiting patients (Current: 23 Nov 2006) - tolevamer potassium-sodium (GT267-004)
• Necrotizing Enterocolitis (NEC) Surgical Database - This study is currently recruiting patients (Current: 23 Nov 2006)
• Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC). - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study - This study is currently recruiting patients (Current: 23 Nov 2006) - Synbiotic 2000
• Addition of Lactobacillus to Metronidazole in Treatment of CDAD - This study has been completed (Current: 23 Nov 2006) - Lactobacillus GG
• Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea - This study is currently recruiting patients (Current: 23 Nov 2006)
• A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea - This study is currently recruiting patients (Current: 23 Nov 2006) - Tolevamer potassium-sodium (GT267-004)
• Cysteine Supplementation in Critically Ill Neonates - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - Parenteral cysteine-HCl supplementation
• Pentoxifylline in the Treatment of NEC in Premature Neonates - This study is currently recruiting patients (Current: 23 Nov 2006) - Pentoxifylline
• Effects of Probiotic and Prebiotic Combinations on Premature Infants - This study is currently recruiting patients (Current: 23 Nov 2006) - Culturelle, ProBioPlus (dietary supplements)
• Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection - This study is currently recruiting patients (Current: 23 Nov 2006) - Nitazoxanide
• Response of Clostridium Difficile Infection to Metronidazole Therapy - This study is currently recruiting patients (Current: 23 Nov 2006) - Metronidazole
• Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody - This study is currently recruiting patients (Current: 23 Nov 2006)
• Vancomycin Vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis - This study is currently recruiting patients (Current: 23 Nov 2006) - Vancomycin,nitazoxanide
• Genomics, SNPs, and Clinical Neonatology - This study is currently recruiting patients (Current: 23 Nov 2006)
• A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - tolevamer potassium-sodium (GT267-004)
• Neurodevelopment and Neuroimaging in Parenterally-Fed Infants and Young Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• Brain Manganese Deposition in High Risk Neonates - This study is currently recruiting patients (Current: 23 Nov 2006)
• Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP) - This study has been completed (Current: 23 Nov 2006) - indomethacin
• Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus - This study is currently recruiting patients (Current: 23 Nov 2006) - indomethacin (two different dosing regimens)
• The Use of Cranberries in Women With Preterm Premature Rupture of Membranes - This study is not yet open for patient recruitment (Current: 23 Nov 2006) - Cranberries - Vaccinium macrocarpon

Drugs used in Clinical Trials for Enterocolitis

The format for each of the following is:

• The drug,
• followed by the name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.

ClinicalTrials.gov has listed the following drugs in trials for Enterocolitis:

• Cranberries - Vaccinium macrocarpon - The Use of Cranberries in Women With Preterm Premature Rupture of Membranes - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Culturelle, ProBioPlus (dietary supplements) - Effects of Probiotic and Prebiotic Combinations on Premature Infants - This study is currently recruiting patients (Current: 23 Nov 2006)
• GT160-246 - A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea - This study has been completed (Current: 23 Nov 2006)
• Indomethacin (Two Different Dosing Regimens) - Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus - This study is currently recruiting patients (Current: 23 Nov 2006)
• Indomethacin - Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP) - This study has been completed (Current: 23 Nov 2006)
• Lactobacillus GG - Addition of Lactobacillus to Metronidazole in Treatment of CDAD - This study has been completed (Current: 23 Nov 2006)
• Metronidazole and Rifampin - Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment - This study has been completed (Current: 23 Nov 2006)
• Metronidazole - Response of Clostridium Difficile Infection to Metronidazole Therapy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Nitazoxanide - Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection - This study is currently recruiting patients (Current: 23 Nov 2006)
• Nitazoxanide - Vancomycin Vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis - This study is currently recruiting patients (Current: 23 Nov 2006)
• Parenteral cysteine-HCl supplementation - Cysteine Supplementation in Critically Ill Neonates - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Pentoxifylline - Pentoxifylline in the Treatment of NEC in Premature Neonates - This study is currently recruiting patients (Current: 23 Nov 2006)
• Synbiotic 2000 - The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study - This study is currently recruiting patients (Current: 23 Nov 2006)
• Tolevamer Potassium-Sodium (Gt267-004) - A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea - This study is currently recruiting patients (Current: 23 Nov 2006)
• Tolevamer Potassium-Sodium (Gt267-004) - A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Tolevamer potassium-sodium (GT267-004) - A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea - This study is currently recruiting patients (Current: 23 Nov 2006)
• Vancomycin - Vancomycin Vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis - This study is currently recruiting patients (Current: 23 Nov 2006)

The trial data on this page has been sourced from

• The U.S. National Library of Medicine (NLM) together with ClinicalTrials.gov

 » Next page: Pseudomembranous enterocolitis (Professional Guide to Diseases (Eighth Edition))

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