NCT06102135

Acceptability and Tolerance Study of Peptide Feed with Fibre

To Evaluate the Acceptability (including Gastrointestinal Tolerance and Compliance) of an Adult Peptide 1.3 Kcal/ml Tube-feed Formula Containing Partially Hydrolysed Guar Gum (PHGG) Fibre.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Enterally fed adults with documented evidence of gastrointestinal intolerance will be recruited. Participants will be deemed by the investigator as having a clinical indication for enteral feeding with a fibre containing peptide formula. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.

Detailed description

To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult enteral peptide formula containing Partially Hydrolysed Guar Gum (PHGG) fibre in 15 patients. This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a fourteen-day period. Data will be collected using patient diaries to asses changes in GI tolerance and tube feed intake.

Conditions

• Dietary Exposure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Peptamen 1.3 PHGG	The amount of tube feed will be assess by the health Care Professional.

Timeline

• Start date: 2023-09-05
• Primary completion: 2024-09-03
• Completion: 2024-09-03
• First posted: 2023-10-26
• Last updated: 2024-09-23

Locations

2 sites across 1 country: United Kingdom