Clinical trial NCT06102135: Acceptability and Tolerance Study of Peptide Feed with Fibre
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Exposure
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess tolerance via patient diaries
timeFrame: 14 days
measure: Daily formula intake
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Nutrition and Dietetics
city: Newcastle
country: United Kingdom
facility: Nutrition and Dietetics
Study officials:
affiliation: Newcastle Upon Tyne Hospital Trust
name: Stephanie Wakefield
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool university Hospital Trust
name: Nirouz Zarroug
role: PRINCIPAL_INVESTIGATOR
References: