A high-protein peptide-based enteral formula improves diarrhea in tube-fed patients. A prospective multicenter study

Phase 3

Completed

• Conditions: Tube-feeding subjects with polymeric formula and has diarrhea symptoms. This study would like to evaluate the effect of oligomeric formulation on GI symptoms.; Diarrhea; tube feeding; Oligomeric

• Registration Number: TCTR20210302006
• Lead Sponsor: Thai Otsuka Pharmaceutical Co., Ltd.

Brief Summary

A high-protein peptide-based enteral formula was effective in reducing stool weight and frequency in patients who experienced diarrhea during tube feeding with a polymeric formula.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-02
• Study Completion: 2021-10-01
• Results First Posted: 2022-11-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Patients of both sexes requiring enteral support who are at least 18 years old
2.Diarrhea after get tube-feeding with polymeric formulation
3.Able to obtain inform consent form patients or his/her legal representative

Exclusion Criteria

1. Get laxatives before enrolment at least 2 days before sign consent
2. Get any medicines that effect to inhibit the digestive system or absorption system
3. Get any medicines that relate with bowel movement such as loperamide
4. Diagnosed with short bowel disease (have less than 200 centimetres), or less than 150 centimetres with has all large intestine
5. Having severe hepatic impairment or diagnosed with class C of Child Pugh Score
6. Allergic to whey, casein or any other components of study formula
7. Diagnosed with pregnancy or in lactation period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diarrhea symptoms improvement Day 0,3,7 of study characteristic, volume, and frequency

Secondary Outcome Measures

Name	Time	Method
1.Other GI symptoms such as vomiting, abdominal distention, aspiration Day 0 to Day 7 (or last visit ) GI side effect daily evaluation ,2. Average gastric residual volume every time before feeding IP Gastric Residual Volume measurement ,3.% Total energy intake in each feeding Proportion calculation from actual feeding volume compared with required feeding volume ,4. Nutrition status Day 0 , Day 7 (Or last visit) retinol binding protein, prealbumin level , Nutrition evaluation form,5. total lymphocyte count (TLC) Day 0 , Day 7 (or last visit) CBC ,6.Nitrogen balance Day 0 , Day 7 (or last visit) Urine 24 hr. collection