NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00085

Registered date:27/03/2012

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

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedCases 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.
Date of first enrollment01/04/2012
Target sample size140
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention1:REF-P1, Dose form:OTHER, Route of administration:NASOGASTRIC, intended dose regimen:1. REF-P1 (1pack) is prescribed to the patient via tube. 2. Enteral nutritional formula is the administered (required Calorie (300-400 kcal/one time)) via tube at a rate of about 100 kcal/30min., within 60 minutes. . Control intervention1:Without REF-P1, Dose form:OTHER, Intended dose regimen:Enteral nutrition is administered in the conventional method..

Outcome(s)

Primary OutcomePneumonia development of symptoms rate . Timepoint:2weeks.
Secondary OutcomeIncidence of diarrhea and malnutrition, administration durations.. Timepoint: 2weeks.

Key inclusion & exclusion criteria

Age minimum>=20 YEARS
Age maximumNo Limit
GenderBOTH
Include 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
Exclude 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.

Related Information

Contact

public contact
Name Kazuhiko Kaneda
Address Research & Development DIV.,5-13-1,sumiyosi-cho,huchu-shi,Tokyo,183-0034
Telephone +81-42-361-0026
E-mail Kazuhiko_kaneda@kewpie.co.jp
Affiliation Kewpie corporation
scientific contact
Name Isao Tabei
Address surgery,4-11-1,Izumihon-cho,Komae-shi,Tokyo,201-8601
Telephone +81-3-3480-1151
E-mail
Affiliation Jikei University School of Medicine Daisan Hospital