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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

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200430002
Enrollment
Unknown
Registered
2020-04-30
Start date
2018-03-21
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Tube Feeding Diarrhea Enteral Nutrition

Interventions

Enteral nutrition products with pectin as a fiber source,Commercial enteral nutrition products that does not contain pectin as a fiber source
Experimental Dietary Supplement,Active Comparator Dietary Supplement
HINE E&#45
Gel,Commercial Concentrated Liquid Diet

Sponsors

Otsuka Pharmaceutical Factory, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Nutritional 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—

Countries

Thailand

Contacts

Public ContactThanon Khongcharoensombat

Chulalongkorn University

chetkc@gmail.com+66 2256 4000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026