Acceptability and Tolerance Study of Peptide Feed With Fibre

Dietary Exposure Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102135
• Other study ID #: Peptide 003
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: September 21, 2024

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: Stephanie Wakefield
• Phone: 0191 282 3345
• Email: stephanie.wakefield3[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 21, 2024
• Est. primary completion date: September 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enterally fed adults feeding taking =60% of nutritional requirements from enteral nutrition

• Patients with documented evidence of feeding intolerance or GI symptoms during enteral feeding, and who in the clinical judgement of the supervising dietitian may benefit from a peptide formula with fibre.

• Aged 18 years and above.

• Willingly given, written, informed consent from patient

Exclusion Criteria:

• Inability to comply with the study protocol, in the opinion of the investigator

• Patients receiving mechanical ventilation, sedation or inotropic support

• Patients on total parenteral nutrition

• Known food allergies to any ingredients (see ingredients list) or galactosaemia

• Patients with significant renal or hepatic impairment

• Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented.

• Participation in another interventional study within 2 weeks of this study.

• Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team.

• Patients with known or suspected ileus or mechanical bowel obstruction.

Related Conditions & MeSH terms

• Dietary Exposure

Intervention

Dietary Supplement:
• Peptamen 1.3 PHGG
The amount of tube feed will be assess by the health Care Professional.

Locations

Country	Name	City	State
United Kingdom	Nutrition and Dietetics	Liverpool
United Kingdom	Nutrition and Dietetics	Newcastle

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess tolerance via patient diaries	Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating	14 days
Primary	Daily formula intake	mL	14 days