A multicenter, randomized, open-label, parallel-group study of EN-P11 in patients with enteral tube feeding.

JRCT ID: jRCT2021230013

Registered date:27/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients with enteral tube feeding.
• Date of first enrollment: 27/07/2023
• Target sample size: 110
• Study type: Interventional
• Intervention(s): Either EN-P11 or control drug is given to patients through enteral tube to perform nutritional management for eleven consecutive days.

Outcome(s)

• Primary Outcome: transthyretin, retinol-binding protein, transferrin

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Receiving enteral feeding via enteral tube.
2. Patients being hospitalized.
3. Aged 18 years or older at the time of obtaining informed consent.
4.Written informed consent of free will has been obtained.

Exclude criteria

1. History of hypersensitivity to any ingredients of study drugs.
2. History of allergy to milk protein.
3. Pateints with Ileus.
4. No residual intestinal function.
5. Severe liver or renal dysfunction (example: acute or chronic renal failure, or cirrhosis).
6. Abnormalities in carbohydrate metabolism including severe diabetes mellitus.
7. Congenital abnormalities in amino acid metabolism.
8. Severe heart disease (example: myocardial infarction), severe hematological disorder (example: aplastic anemia), inflammatory bowel disease, pneumonia, serious diarrhea (example: frequent watery diarrhea), and malignant tumor.
9. Pregnant or wish to become pregnant.
10. History of resection of gastrointestinal tract (esophagus, stomach or intestines) within 1year before obtaining informed consent , except for slight removal like polyp or appendectomy.
11. Taking a diet (regular diet, swallowing control diet, blender diet or paste diet).
12. Difficult to take required amount of blood sample for clinical trial.
13. Participated in clinical trial or the use of unapproved drugs within 24weeks before obtaining informed consent.
14. History of surgery within 4weeks before registration (in case of gastrostomy, minor surgery such as debridement for pressure ulcers, within 2weeks before registration).
15. History of fasting for 3or more consecutive days within 4weeks before registration.
16. Screening test 1
1) Serum AST :100 U/L or more
2) Serum ALT :113 U/L or more
3) Serum Cre :2 mg/dL or more
4) Blood HbA1c :8.0% or more
5) Blood WBC :over 9000/uL
6) Serum CRP :3.0 mg/dL or higher
7) Urinary HCG :positive (not required if menopause has been confirmed, there is no possibility of pregnancy due to surgical procedures in the past, or if it can be confirmed that there has been no sexual activity for more than 1year)
17. Screening test 2
Body temperature :37.5 degrees Celsius or higher (on registration day).
18. Judged by investigator to be excluded.

Related Information

• Primary Sponsor: Michio Maruyama