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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying the development of functional gastrointestinal disorders (FGIDs) in infants who are fed a new infant formula. This research uses the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale to measure these disorders. The study is interventional, open-label, and involves multiple centers, focusing on infants with FGIDs as defined by adapted Rome IV criteria. The study includes a treatment period where infants receive the new infant formula over a total of four months. The study is divided into an initial 30-day period followed by an optional 90-day intervention period. The formula is provided as a dietary supplement specifically designed for this study. During the study, caregivers and researchers will monitor the infants' gastrointestinal symptoms using the GIGER scale, with the primary outcome assessed on day 30. Participants' progress and any changes in symptoms will be evaluated throughout the intervention. Safety and adherence to the feeding regimen will also be observed to better understand the formula's impact on FGIDs.

Age: 0 - 4MonthsAll GendersPhase Not Applicable
4 locations
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Actively Recruiting

Multivisceral failure syndrome (MVFS) and monovisceral failure in intensive care patients have a high risk of mortality, ranging from 30 to 50%. This syndrome involves significant inflammation and a high risk of bacteremia, often linked to increased intestinal barrier permeability, which has not been systematically measured in humans. The study aims to investigate the relationship between intestinal permeability and survival in intensive care patients with single or multiple organ failure, using methods previously studied in animal models. Participants will receive an oral dose of 0.5 mg/kg of body weight of a food coloring dye as a dietary supplement to measure intestinal permeability. The study includes two groups: patients with single organ failure secondary to sepsis, and patients with multi-organ failure syndrome, both admitted to intensive care. Feeding must be possible either by mouth or nasogastric tube independent of the study requirements. During the study, researchers will monitor intestinal permeability and survival up to 90 days after inclusion. They will collect clinical data, including severity scores and organ failure status. Consent and social security affiliation are required. The study carefully follows patient safety and includes regular assessments to understand how intestinal permeability relates to outcomes in this critically ill population.

Age: 18Years +All Genders
1 location
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Actively Recruiting

The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is an important public health concern, especially in children with urinary tract infections (UTIs). These bacteria can lead to increased use of penem antibiotics, which may cause resistant strains. This study evaluates the effects of different antibiotic treatments on the presence of E-ESBL in the digestive tract of children aged 3 months to under 3 years who have febrile UTIs. The goal is to compare the impact of intravenous amikacin versus intravenous or intramuscular ceftriaxone or oral cefixime on the emergence of these bacteria in stools. Participants receive one of the antibiotic treatments as monotherapy: amikacin given intravenously, ceftriaxone administered either intravenously or intramuscularly, or cefixime taken orally. Before starting treatment, an anorectal swab is collected to check for E-ESBL bacteria, and a second swab is taken three to four days after beginning the antibiotic therapy to monitor any changes. During the study, children are monitored for the presence of E-ESBL in their stools on day 4 through these swabs. Parents provide consent and confirm their understanding of the study information. The study measures the bacterial carriage in the digestive tract after treatment and ensures safety by excluding children currently hospitalized or on multiple antibiotics. The participation duration aligns with the timing of these assessments.

Age: 3Months - 3YearsAll Genders
20 locations
S

Actively Recruiting

Researchers are studying the effectiveness and tolerance of a new anti-regurgitation infant formula designed to reduce regurgitation episodes in infants with gastroesophageal reflux. This randomized, controlled, double-blind trial compares the new formula thickened with fibers to a formula thickened with locust bean gum. The goal is to assess how well the new formula reduces regurgitation frequency and its effects on digestive tolerance. Participants will exclusively feed their infants either the experimental formula or the comparator formula during the study. The study lasts for 1 month and 2 days, beginning with a 2-day pre-selection period, followed by a 30-day follow-up period. There is an optional additional 2-month follow-up phase to further monitor the infants. During the study, parents and researchers will track the frequency of regurgitation on day 14 as the primary outcome. Other assessments include monitoring digestive tolerance and overall infant health. Parents provide informed consent and participate in feeding and observation activities throughout the study duration, which may last up to 3 months if the optional follow-up is added.

Age: 2Weeks - 4MonthsAll GendersPhase Not Applicable
12 locations
Vincennes Clinical Trials | DecenTrialz