Multicenter randomized clinical trial for the nutrition therapy using JANEF REF-P1 (viscosity regulatory food) with patients on enteral nutritio

Not Applicable

Completed

• Conditions: Cases that require enteral nutrition due to malnutrition. Improvement of REF P-1 in aspiration pneumonitis caused by esophageal gastro reflux, and diarrhea resulting use of enteral nutrition is to be clarified.

• Registration Number: JPRN-jRCT1090220085
• Lead Sponsor: Jikei University School of Medicine Daisan Hospital

Brief Summary

The method of adding viscosity regulation solution to conventional EN solution, not only suppresses the occurrence of aspiration pneumonia and reduces the administration duration time compared to conventional methods, but also prevented diarrhea and improved the form of the stool. For which activity time is increased rather than feeding time, and then the patients have more time to spend for rehabilitation and everyday life etc.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-27
• Study Completion: 2014-07-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

(1)Independent of the original disease, patients with malnutrition due to per oral food intake in need of artificial nutritional therapy. Those planed for enteral nutrition though tube feeding via methods such as Percutaneous Endoscopic Gastrostomy(PEG), Percutaneous Trans Esophageal Gastrotubing (PTEG), Nasogastric Tube (NGT ) etc.
(2) Patient planned for enteral nutrition for more than for 14 days.
(3) Patient aged 20 and over at the time of registration.
(4) Patients with prognosis of more than 3 months.
(5) Patient with written consent for participation to the study

Exclusion Criteria

(1)Patients with absorption disorder unsuitable for enteral nutrition, i.e. inflammatory bowel disease etc.
(2)Patients with pyrexia (more than 37.5C).
(3)Patient under infectious disease.
(4)Patient with critical complications (cardiac disease, pulmonary and interstitial pneumonia, hemorrhagic disorder, uncontrolled hypertension, diabetes, etc.).
(5)Patients prescribed with drugs having effects such as diarrhea and vomiting.
(6)Patients with symptoms of diarrhea, vomiting, etc. due to the underlying disease.
(7)Patients with prevailing symptoms of gastro esophageal reflux at time of enrollment.
(8)Patients with prevailing symptoms of pneumonia and/or diarrhea at time of enrollment.
(9)Patients judged unfit for the study by investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified