Acceptability and Tolerance Study of Peptide Feed with Fibre

NCT06102135 | Completed

• 1 other identifier: Peptide 003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dietary Exposure

Outcome Measures

Primary Outcomes (2)

• Assess tolerance via patient diaries

  Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating

  14 days

• Daily formula intake

  mL

  14 days

Study Arms (1)

Patients well established on tube feeds will act as their own control

OTHER

Patients in the control group will switch from current feed to new tube feed to assess tolerance and acceptability.

Dietary Supplement: Peptamen 1.3 PHGG

Interventions

Peptamen 1.3 PHGG DIETARY_SUPPLEMENT

The amount of tube feed will be assess by the health Care Professional.

Patients well established on tube feeds will act as their own control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (2)

Nutrition and Dietetics

Liverpool, United Kingdom

Location

Nutrition and Dietetics

Newcastle, United Kingdom

Location

Study Officials

• Stephanie Wakefield

  Newcastle Upon Tyne Hospital Trust

  PRINCIPAL INVESTIGATOR

• Nirouz Zarroug

  Liverpool university Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: October 26, 2023
• Study Start: September 5, 2023
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: September 23, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)