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

The effect of oligomeric formula on diarrheal symptoms in tube-fed patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210302006

Enrollment

Registered

2021-03-02

Start date

2021-03-08

Completion date

Unknown

Last updated

2026-03-30

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

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

Interventions

Oligomeric formula will be given via feeding tube for maximum 7 days . Dose will be adjusted follow individual calories requirement

Active Comparator Other

Oligomeric enteral formula

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Diarrhea symptoms improvement Day 0,3,7 of study characteristic, volume, and frequency	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Thailand

Contacts

Public ContactThipvadee Yamchuenpong

THAI OTSUKA PHARMACEUTICAL CO., LTD.

thipvadee@thai-otsuka.co.th0632378178

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026