About this deal
The rationale behind using UCED with PEN is: to support dietary intake with an oral liquid formula (pilot studies showed a decreased energy intake), to provide balance of micro- and macronutrients, to increase adherence and efficacy, to help deliver optimal fiber, and to help personalize recommendations.
Group 3 (UCED alone) showed the highest rate of clinical remission (40%) and endoscopic remission (27%). Group 3 also demonstrated a significant decrease in the Simple Clinical Colitis Activity Index (SCCAI) at week 8. A significant proportion of patients worsened after FT (Group 1 or Group 2) by week 8 compared to baseline. Group 3 reported the least worsening of disease. Median Pediatric Ulcerative Colitis Activity Index (PUCAI) decreased from a baseline of 35 (30–40) to 12.5 (5–30) at week 6 (p=0.001). Mechanisms of action of Modulen ® on intestinal epithelium. The left panel represents the consequences of a liquid, exclusive, and fibers/lactose/gluten-free diet, as well as TGF(transforming growth factor-beta) MCT (medium-chain triglycerides), palmitic acid, α-linolenic acid, and 15-HETE (15-hydroxyeicosatetraenoic acid);. The right panel focuses on leucine, caprylic, glutamic and palmitic acid, MCT, TGF-β, and β-casofensin.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-regarding-investigational-new-drug-requirements-use-fecal-microbiota-0 Immunomodulators are important for patients with IBD and mainly include thiopurines (TPs), methotrexate (MTX), calcineurin inhibitors, and Janus Kinase (JAK) inhibitors. The studies on the efficacy and safety of immunomodulators in IBD are summarized in Supplementary Table 1. TPs
Suskind DL, Lee D, Kim YM, Wahbeh G, Singh N, Braly K, Nuding M, Nicora CD, Purvine SO, Lipton MS, Jansson JK, Nelson WC. The Specific Carbohydrate Diet and Diet Modification as Induction Therapy for Pediatric Crohn's Disease: A Randomized Diet Controlled Trial. Nutrients. 2020 Dec 6;12(12):3749. doi: 10.3390/nu12123749. Poate fi folosit ca sursă unică de nutriție în faza acută a bolii Crohn sau pentru completarea alimentației în perioadele de remisie; Clinical outcomes were consistent in adults and children. 60% of adults achieved clinical response vs 71% of children. 40% of adults and 38% of children achieved clinical remission. In a 12-week prospective trial of children with mild to moderate CD conducted in 2019 1, children were randomly assigned to a group that received CDED plus 50% of calories from partial enteral nutrition (PEN, Modulen IBD) for 6 weeks (phase 1), followed by CDED with 25% PEN from weeks 7 to 12 (phase 2).
General Measures and Education
The diet emphasizes components that offer a protective effect, including fruit and vegetable fibers, pectin and resistant starch, and tryptophan. UCED has some important distinctions from the CDED: Studies are now underway to establish if an Ulcerative Colitis Exclusion Diet (UCED) could provide a treatment option for UC patients. A randomized controlled trial demonstrated that more than 80% of patients with severe acute refractory UC responded to CsA ( 58). It has been reported that the 8-day clinical remission rate (84.2 vs. 85.7%) of patients with severe UC treated with intravenous 4 mg/kg CsA is similar to that of patients treated with intravenous 2 mg/kg CsA ( 59). Stange et al. performed a randomized controlled trial to delineate the long-term effect of CsA on chronic active CD and found that CsA combined with low-dose steroids had no advantage over the sole use of low-dose steroids ( 60).