Clinical trials: Enterocolitis
Clostridium Difficile Infection Recurrence
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy.
- Trial name
- CDI-SCOPE (NCT05831189)
- Testing
- RBX2660
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Ferring Pharmaceuticals
Necrotizing Enterocolitis, Intra-abdominal Infection
Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known.
- Trial name
- NCT00621192
- Testing
- meropenem
- Where
- 26 sites in United States
- Volunteers
- 200 people
- Sponsor
- The Emmes Company, LLC
Late Onset Neonatal Sepsis, Necrotizing Enterocolitis
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- Trial name
- NCT02073214
- Testing
- Probiotic
- Volunteers
- 182 people
- Sponsor
- IBSS Biomed S.A.
Clostridium Enterocolitis, Diarrhea
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C.
- Trial name
- NCT00196794
- Testing
- Tolevamer potassium-sodium (GT267-004)
- Where
- 138 sites in Australia, Austria and 12 more
- Volunteers
- 520 people
- Sponsor
- Genzyme, a Sanofi Company
Clostridium Difficile Infection, Diarrhea
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility.
- Trial name
- NCT01230957
- Testing
- Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant), Clostridium difficile toxoids A and B (high-dose with adjuvant)
- Where
- 30 sites in United States
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Type 2 Inflammatory Disorders
Compassionate Use or Expanded Access of Dupilumab
Provide Compassionate Use or Expanded Access of Dupilumab
- Trial name
- NCT04776694
- Testing
- Dupilumab
- Sponsor
- Regeneron Pharmaceuticals
Necrotizing Enterocolitis
Monitoring Necrotizing Enterocolitis in Premature Infants
The investigators are studying a disease called "necrotizing enterocolitis" (or "NEC" for short), which affects premature infants.
- Trial name
- NCT01287559
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Spectros Corporation
Necrotizing Enterocolitis
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or…
- Trial name
- NEC (NCT06315738)
- Testing
- ST266
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Noveome Biotherapeutics, formerly Stemnion
Pseudomembranous Colitis, Clostridium Difficile Diarrhea
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD).
- Conditions
- Pseudomembranous Colitis, Clostridium Difficile Diarrhea, Antibiotic-Associated Diarrhea
- Trial name
- NCT00382304
- Testing
- tolevamer potassium-sodium (GT267-004)
- Where
- 8 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Genzyme, a Sanofi Company
Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom.
- Conditions
- Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis, Clostridium Difficile Diarrhea, Antibiotic-associated Colitis
- Trial name
- NCT00034294
- Testing
- GT160-246
- Where
- 99 sites in United States, Canada and 2 more
- Volunteers
- 300 people
- Sponsor
- Genzyme, a Sanofi Company
Necrotizing Enterocolitis
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
- Trial name
- NCT00977912
- Testing
- Probiotic supplementation
- Where
- 3 sites in South Africa
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Moderate Clostridium Difficile Infection
Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.
- Trial name
- NCT01232595
- Testing
- LFF571, Vancomycin (POC)
- Where
- 18 sites in United States, Canada
- Volunteers
- 109 people
- Sponsor
- Novartis Pharmaceuticals
Anaerobic Infection, Infectious Enterocolitis
Anaemetro I.V. Infusion 500mg Drug Use Investigation
Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
- Conditions
- Anaerobic Infection, Infectious Enterocolitis, Amebic Dysentery
- Trial name
- NCT03491228
- Volunteers
- 107 people
- Sponsor
- Pfizer
NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations
Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations
This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations.
- Trial name
- MASter-1 (NCT04641442)
- Testing
- MAS825
- Where
- 12 sites in United States, Czechia and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Necrotizing Enterocolitis
IBP-9414 for the Prevention of Necrotizing Enterocolitis
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
- Trial name
- NCT02472769
- Testing
- IBP-9414
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- Infant Bacterial Therapeutics
Necrotizing Enterocolitis
IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.
- Trial name
- NCT03978000
- Testing
- IBP-9414
- Where
- 89 sites in United States, Bulgaria and 8 more
- Volunteers
- 2,158 people
- Sponsor
- Infant Bacterial Therapeutics
Clostridium Difficile Infection, Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of…
- Conditions
- Clostridium Difficile Infection, Infection, Communicable Diseases
- Trial name
- CD3-OLS (NCT03931941)
- Testing
- RBX2660
- Where
- 51 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Rebiotix Inc.
Antibiotics Associated Colitis, Pulmonary Infection
Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
Antibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is relatively infrequent in outpatients.
- Trial name
- NCT01058356
- Where
- South Korea
- Volunteers
- 214 people
- Sponsor
- Pharmbio Korea Co., Ltd.
Enterocolitis Clostridium Difficile Recurrent
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C.
- Trial name
- PUNCHCD2 (NCT02299570)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 21 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- Rebiotix Inc.
Necrotizing Enterocolitis
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
- Trial name
- NCT01954017
- Testing
- STP206, Control
- Where
- 13 sites in United States
- Volunteers
- 103 people
- Sponsor
- Leadiant Biosciences, Inc.