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

JMACCT ID: JMA-IIA00085

Registered date:27/03/2012

Basic Information

• Recruitment status: Completed
• Health condition(s) or Problem(s) studied: 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.
• Date of first enrollment: 01/04/2012
• Target sample size: 140
• Countries of recruitment: Japan
• Study type: INTERVENTIONAL

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 Outcome: Pneumonia development of symptoms rate . Timepoint:2weeks.
• Secondary Outcome: Incidence of diarrhea and malnutrition, administration durations.. Timepoint: 2weeks.

Key inclusion & exclusion criteria

• Age minimum: >=20 YEARS
• Age maximum: No Limit
• Gender: BOTH

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

• Primary Sponsor: Jikei University School of Medicine Daisan Hospital

Secondary Sponsor

Fukuoka Saiseikai General Hospital
Ushiku Aiwa General hospital
Tsuchida hospital
Ohta hospital
Chiba Kashiwa Tanaka Hospital
SHIN-YURIGAOKA General Hospital

• Source(s) of Monetary Support: Kewpie corporation