1. HARMONY - A Trial to Evaluate the Safety and Efficacy of Amitiza (Lubiprostone) in Children with Constipation

    Submitted by centretek on Sat, 10/15/2022 - 10:29
    Summary
    The goal of this study is to evaluate the safety and efficacy of Amitiza (lubiprostone) in children with constipation. Even though traditional treatment of functional constipation in children is available and safe, for many patients it does not provide a satisfying improvement, prompting interest in other therapeutic strategies. Since lubiprostone has been shown to increase the frequency of spontaneous bowel movements (SBMs) in both adults and children, further evaluation in well controlled studies in children is needed to demonstrate use in a paediatric population. Study requires use of an electronic diary nightly, 6 visits and 5 blood draws.
  2. The Impact of Gastric Acid Suppression on the Developing Intestinal Microbiome of A Child

    Submitted by centretek on Sat, 10/15/2022 - 10:29
    Summary
    Medications to suppress gastric acid are often used in children for conditions such as gastroesophageal reflux disease or GERD. We are learning more about potential side effects of these medications including Clostridium difficile infection and small bowel bacterial overgrowth which may be due to the underlying effect of these medications on the intestinal microbiome. The microbiome of a child develops in the first few years of life and so young children may be particularly vulnerable to these medications. We are examining the gut microbiome of young children before and after using these medications. This will give insight into possible mechanisms for reported side effects and may give data to guide appropriate use of these commonly used medications in childhood.
  3. Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) That Progressed After Platinum Therapy and

    Submitted by centretek on Sat, 10/15/2022 - 10:29