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Enterocolitis clinical trials

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NCT ID: NCT02472769 Completed - Clinical trials for Necrotizing Enterocolitis

IBP-9414 for the Prevention of Necrotizing Enterocolitis

Start date: May 27, 2016
Phase: Phase 2
Study type: Interventional

Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.

NCT ID: NCT02444624 Completed - Clinical trials for Necrotizing Enterocolitis

Clostridium and Neonatal Necrotizing Enterocolitis Pathophysiology : Clinical and Molecular Approaches

CLOSNEC
Start date: May 28, 2015
Phase:
Study type: Observational

The clinical study involves a French network of 20 neonatology centres created as part of the EPIFLORE project. Investigators propose including all premature babies with confirmed necrotizing enterocolitis (NEC) diagnosis (Bell stage II or III) paired with a control group of healthy premature babies, over a 2-year period. The clinical data will be entered at inclusion until departure from the department, and the ASQ (Ages and Stages Questionnaires) will be collected after 24 months. Samples from NEC cases and from the control group will be submitted for microbiological testing by culture and pyrosequencing. This will enable the main aerobic micro-organisms in the dominant and subdominant intestinal microbiota to be isolated. This case-control study will be used to compile a collection of clinical and microbiological data, in order to confirm the role of bacteria in the pathophysiology of NEC, and to confirm the involvement of bacteria from the Clostridium genus in particular.

NCT ID: NCT02405637 Recruiting - Clinical trials for Necrotizing Enterocolitis

Simulated Amniotic Fluid In Preventing Feeding Intolerance and Necrotizing Enterocolitis VLBW Neonates

Start date: March 2014
Phase: Phase 1
Study type: Interventional

The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.Growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding intolerance is a common problem among premature neonates, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in premature neonates.

NCT ID: NCT02400697 Completed - Sepsis Clinical Trials

Placental Transfusion Project for Preterm Infants

Start date: September 2014
Phase: N/A
Study type: Observational

The American College of Obstetrics and Gynecology, American Academy of Pediatrics and the World Health Organization have recently published recommendations related to placental transfusions in preterm infants. This project will review outcomes of preterm infants following a quality improvement implementation process in several delivery centers in Indiana. Centers involved in this project are also part of the Indiana Vermont Oxford Network (IRB#1003-84). Data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the Vermont Oxford Network collection. This project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the ACOG recommendations.

NCT ID: NCT02390622 Recruiting - Clinical trials for Methicillin-Resistant Staphylococcus Aureus

Biotherapy for MRSA Enterocolitis

Start date: July 2013
Phase: N/A
Study type: Interventional

Methicillin-resistant Staphylococcus aureus (MRSA) is one of the major sources of nosocomial infection. Along with the widely application of antibiotics around perioperative period, MRSA infection is increasing by years.Fecal microbial transplantation (FMT),infusion of fecal preparation from a healthy donor into the GI tract of a patient is being proposed as a novel therapeutic approach to modulate diseases associated with pathological imbalances within the resident microbiota, termed dysbiosis.It has been used to treat intestinal disease such as inflammatory bowel diseases and Clostridium difficile infection, but no reports are available on its role in treating MRSA enteritis yet. vancomycin is the first choice to treat MRSA but can also lead to an increase in antibiotic resistant organisms such as vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus and transfer of antibiotic resistance genes among the microbial community. So FMT seems a more harmless and reasonable measure to treat similar diseases.

NCT ID: NCT02383264 Completed - Clinical trials for Necrotizing Enterocolitis

Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.

NIRS-SO
Start date: February 2013
Phase: N/A
Study type: Observational

Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis (NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the establishment of an adequate early enteral nutrition is frequently hampered. Early identification of preterm infants at high risk for gastrointestinal complications could help clinical decisions on the introduction and the advancement of enteral feeding. Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the first week of life and subsequent NEC development has been reported. To date, however, splanchnic oxygenation patterns in response to the first bolus feed and possible correlations with subsequent FI development have not been yet established. This observational prospective study aims: - to assess abdominal rSO2 patterns in response to the first bolus feed; - to evaluate possible correlations with subsequent development of gastrointestinal complications.

NCT ID: NCT02347475 Completed - Clinical trials for Necrotizing Enterocolitis

SMA Flow Patterns in Neonatal Transfusion

SPARTAN
Start date: January 2015
Phase:
Study type: Observational

This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in premature neonates. These changes will be measured in relation to feeding, before and after a blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing enterocolitis (NEC) - a condition with significant mortality and long term morbidity. Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for planning, studying and implementing risk avoidance and minimization strategies.

NCT ID: NCT02343562 Recruiting - Clinical trials for Hirschsprung Disease

Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis

Start date: October 2014
Phase: Phase 4
Study type: Interventional

Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The objective of the trial is to prevent postoperative HAEC by using Probiotics.

NCT ID: NCT02299570 Completed - Clinical trials for Enterocolitis Clostridium Difficile Recurrent

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

PUNCHCD2
Start date: December 2014
Phase: Phase 2
Study type: Interventional

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. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

NCT ID: NCT02254811 Completed - Clinical trials for Enterocolitis Clostridium Difficile Recurrent

FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

Start date: September 18, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized successfully. Endoscopic delivery requires significant health care utilization and associated cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality, which would significantly reduce patient discomfort, procedure related risks and health care costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.