Tokyo, Sept. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062936) titled 'An exploratory study on the safety and feasibility of enteral tube administration of pouched konjac paste in critically ill patients receiving enteral nutrition in the intensive care unit' on Sept. 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Subaru Health Insurance Society Ota Memorial Hospital

Condition: Condition - Critically ill patients admitted to the intensive care unit (ICU) who are receiving enteral nutrition via a nasogastric tube or gastrostomy (PEG) tube; bowel management (diarrhea and constipation) during enteral nutrition Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Early enteral nutrition is recommended for critically ill patients in the ICU, but diarrhea and constipation occur frequently during enteral nutrition management and often prevent adequate delivery of enteral nutrition. Glucomannan, the dietary fiber contained in konjac, has a bowel-regulating action and is expected to improve bowel management.

This study is a feasibility study conducted in preparation for a future randomized controlled trial of efficacy. A pouched konjac paste whose viscosity has been adjusted for enteral tube administration will be given through the feeding tube to ICU patients receiving enteral nutrition, in order to clarify the following:

Safety: incidence of gastrointestinal symptoms (diarrhea, abdominal distension) and of feeding tube trouble Feasibility: smoothness of the administration process and the workload imposed on nursing staff Exploratory efficacy: changes in stool frequency and stool consistency (preliminary data collection)

Prior to this clinical study, an in vitro preliminary experiment was performed on the prepared konjac paste product to evaluate its physical properties (line spread test, LST) and its passage through feeding tubes under simulated gastric fluid (pH 1-2) and simulated intestinal fluid (pH 7.0) conditions (37 degrees Celsius, 1 hour per phase). The mean LST value was 36 mm immediately after opening, and increased to 48 mm after 1 hour in the gastric phase and to 58 mm after 1 hour in the intestinal phase (up to 67 mm when mixed with an enteral formula), confirming increased flowability under conditions simulating the internal environment (reference value for enteral tube administration: LST 43 mm or greater). In the tube passage test, the konjac paste did not cause tube occlusion, and no residue was observed after flushing. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - In addition to routine enteral nutrition management, all 10 enrolled patients receive pouched konjac paste with viscosity adjusted for enteral tube administration (prepared by ORIHIRO Plandu Co., Ltd.). Dose: one pouch (100 mL) per administration, twice daily. Procedure: the pouch is connected to the connector of the enteral feeding tube and the content is injected; the tube is then flushed with 20 mL of lukewarm water. Duration: 7 days from the start of the intervention, ending at discharge from the ICU or at the start of oral intake. During the intervention period, the attending physician performs a daily abdominal examination and checks the condition of the feeding tube. Stool frequency, stool consistency and related items are recorded daily; these are observations within the scope of routine clinical care. Discontinuation criteria: administration is stopped immediately in the event of worsening abdominal distension, vomiting, feeding tube occlusion, severe diarrhea, or any other situation in which the physician judges that continuation is difficult.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged 18 years or older admitted to the Emergency and Critical Care Center (ICU) of Ota Memorial Hospital 2. Patients in whom enteral nutrition via a nasogastric tube or gastrostomy (PEG) tube is being started 3. Patients in whom enteral nutrition is expected to continue for 7 days or longer 4. Patients from whom written informed consent has been obtained, either from the patient or from a legally acceptable representative Key exclusion criteria - 1. Patients with a history or suspicion of gastrointestinal obstruction (ileus) 2. Patients immediately after gastrointestinal surgery, or with active gastrointestinal bleeding 3. Patients with unstable hemodynamics and a high risk of intestinal ischemia 4. Patients using an enteral feeding tube smaller than 12 Fr, in whom the risk of occlusion is judged to be high 5. Patients with konjac allergy Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 15 Day Date of IRB - 2026 Year 06 Month 23 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2027 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072060

Disclaimer: Curated by HT Syndication.