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

Multicenter randomized clinical trial for the nutrition therapy using "JANEF REF-P1 (viscosity regulatory food)" with patients on enteral nutrition - RCT of REFP-1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1090220085

Enrollment

140

Registered

2012-03-27

Start date

2012-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Intervention type: Name of intervention:REF-P1 Dose form / Japanese Medical Device Nomenclature:OTHER Pectin Solution(Food) Route of administration / Site of application:NASOGASTRIC,GASTROENTERAL Dose

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pneumonia development of symptoms rate	—

Secondary

Measure	Time frame
Incidence of diarrhea and malnutrition, administration durations.	—

Countries

Japan

Contacts

Public ContactKazuhiko Kaneda

Kewpie corporation

Kazuhiko_kaneda@kewpie.co.jp+81-42-361-0026

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026