Study of effects of a new concentrated liquid diet on gastrointestinal symptoms during the nutritional management after maxillofacial surgery.
Phase 3
- Conditions
- Patients undergoing oral surgery
- Registration Number
- JPRN-UMIN000013012
- Lead Sponsor
- Tokyo medical and dental university (gudaduate school)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who take or receive the drugs prohibited to use during the study period 2) Patients who have the disease history of gastroduodenal ulcer or other upper gastrointestinal diseases 3) Patients who might have food allergies or allergies to the products used in the study 4) Patients who receive anticancer drugs or radiotherapy 5) Patients who deemed to be unsuitable for inclusion in the study due to concomitant diseases including hepatic disorder, renal disorder, and cardiac disorder 6) Female patients who are pregnant, lactating, or potentially pregnant 7) 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 An achievement rate of nutritional control When all the following conditions are met, the nutritional control is defined to be "achieved." - Ninety percent or more of the targeted amount of test diet was administered. - The number of use of antiflatulents is two or smaller. - The frequency of stool per day is three times or lower. - Neither watery stool nor muddy stool was observed.
- Secondary Outcome Measures
Name Time Method - Nutritional parameters (blood albumin, blood total protein, body weight)