A Randomized, Controlled Parallel Study to Compare Efficacy and Safety of HINE E-GEL with General Concentrated Liquid Diet with Tube Feeding †An Exploratory Study

Phase 2

Completed

• Conditions: Tube FeedingDiarrheaEnteral Nutrition

• Registration Number: TCTR20200430002
• Lead Sponsor: Otsuka Pharmaceutical Factory, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-04-19
• Study Start: 2020-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patients aged 18 years or older on the date of informed consent.
2.Patients already hospitalized and undergoing tube feeding with 12-16 Fr nasogastric tube or percutaneous endoscopic gastrostomy (PEG) feeding tubes, and who prospectively will be on tube feeding at least 9 days after inclusion.
3.Patients who provide voluntary consent after receiving a sufficient oral and written explanation about the study. If the patient is unconscious, a patient’s legal representative may also provide consent.

Exclusion Criteria

1.Patients who have a previous history of gastrectomy or other upper gastrointestinal disorders that unsuitable for inclusion in the study.
2.Patients who might have food allergies or allergies to any of the products used in the study.
3.Patients who receive anticancer drugs or radiotherapy.
4.Patients who are deemed unsuitable for inclusion in the study due to concomitant diseases including hepatic disorder, renal disorder, and cardiac disorder.
5.Others who are deemed unsuitable for inclusion in the study for any other reason based on decision by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bowel movement For 7 days Observation (Bristol Stool Scale 6 or 7, 3 times or more per day) by the study nurse,Frequency of defecation and properties of stool For 7 days Observation by the study nurse

Secondary Outcome Measures

Name	Time	Method
utritional parameters (transthyretin and body weight) Screening phase and in the follow-day (Day 10) Transthyretin in serum,Subjective Global Assessment (SGA) Screening phase and in the follow-day (Day 10) Dietician assessed outcome using a questionnaire