Vincennes

Researchers are studying infants with functional gastrointestinal disorders FGIDs to see how these conditions change when fed a new infant formula. This open-label, interventional, non-comparative multicenter study uses the Gastrointestinal and Gastroesophageal Reflux GIGER scale to evaluate symptoms like regurgitations, colic, and constipation. The study focuses on infants up to 4 months old who have at least one FGID based on adapted Rome IV criteria. The study involves feeding infants a thickened infant formula containing fibers and probiotics over two periods a first 30-day period followed by an optional 90-day intervention period. The new formula is given continuously during the total 4-month study duration. Researchers will monitor various symptoms and digestive functions using the GIGER scale and other assessments throughout these periods. Participants will be evaluated regularly with measures including regurgitation frequency and severity, stool characteristics, colic, gas severity, abdominal distension, sleep quality, infant growth parameters, and quality of life. Parents will also report satisfaction. Safety is monitored by recording any adverse events through study completion. The primary outcome is the change in GIGER score from baseline at Day 30, with ongoing assessments up to Day 120 for those continuing in the optional period.

Multivisceral failure syndrome MVFS is a serious condition with a high risk of death, often linked to significant inflammation and infection in intensive care patients. This study investigates the role of increased intestinal permeability, which may allow bacteria to pass from the gut into the bloodstream, contributing to infection and poor outcomes. Researchers aim to understand how intestinal permeability relates to survival in patients with one or multiple organ failures caused by sepsis. Participants will be grouped based on the severity of their condition. One group includes patients with single organ failure and a SAPS2 score between 20 and 40, while the other includes those with multiple organ failures and a SAPS2 score between 60 and 80. Participants will receive an oral dose of a food coloring dye to measure intestinal permeability. The study is observational and will monitor these patients without altering their standard clinical care. Throughout the study, patients will be assessed for intestinal permeability and organ failure severity. The main outcome is survival and intestinal failure 90 days after inclusion. Researchers will also track changes in intestinal permeability over time. Data collection includes clinical monitoring, consent processes, and evaluation of feeding ability. The study starts in February 2025 and ends in April 2029.

The trial investigates the impact of different antibiotic treatments on the digestive tract colonization by extended-spectrum beta-lactamase-producing Enterobacteriaceae E-ESBL in children with febrile urinary tract infections UTIs. E-ESBL bacteria are a significant public health concern due to their resistance to many antibiotics. This research compares the emergence of E-ESBL strains in stools following treatment with either intravenous amikacin or other recommended antibiotics like ceftriaxone or cefixime in young children. Participants receive treatment for febrile UTIs with either amikacin given intravenously or with usual antibiotics such as intravenous or intramuscular ceftriaxone or oral cefixime. Before starting antibiotics, an anorectal swab is taken to check for E-ESBL colonization. A follow-up swab is performed three to four days after starting treatment to assess changes in bacterial presence. Children are monitored for the presence and type of E-ESBL bacteria in their stools four days after treatment begins. Researchers also track antibiotic resistance patterns, fever resolution, side effects related to antibiotic use, and the rate of UTI relapse over one and a half months. Participation involves stool sampling and clinical evaluations during the treatment period, with the study expected to complete by mid-2026.

Researchers are evaluating a new anti-regurgitation infant formula to see how well it reduces regurgitation episodes and improves digestive tolerance in infants with gastroesophageal reflux. This is a randomized, controlled, double-blind trial comparing the new formula to a standard thickened formula. The study is sponsored by United Pharmaceuticals and focuses on infants between 2 weeks and 4 months old. The study includes two groups one receiving the new formula thickened with fibers and the other receiving a formula thickened with locust bean gum. The trial lasts for 1 month and 2 days, starting with a 2-day pre-selection period followed by a 30-day follow-up. Participants can optionally continue for an additional 2 months of follow-up from day 30 to day 90. During the study, infants will be monitored for the frequency and severity of regurgitations, digestive symptoms like diarrhea and constipation, feeding behaviors, sleep quality, and growth measurements including weight, length, head circumference, and BMI. Parents and investigators satisfaction will also be recorded. These assessments occur at days 14, 30, and 90. The primary outcome is the frequency of regurgitation at day 14. All study visits and evaluations are conducted under careful monitoring to track safety and treatment effects.