Acceptability and Tolerance Study of Peptide Feed with Fibre | NCT06102135

Studies
Acceptability and Tolerance Study of Peptide Feed with Fibre

NCT06102135

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Sep 23, 2024Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Dietary Exposure

Interventions

Peptamen 1.3 PHGG

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2023Actual

Primary Completion Date

Sep 3, 2024Actual

Completion Date

Sep 3, 2024Actual

First Submitted Date

Aug 22, 2023

First Submission Date that Met QC Criteria

Oct 20, 2023

First Posted Date

Oct 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2024

Last Update Posted Date

Sep 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess tolerance via patient diaries	Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating	14 days
Daily formula intake	mL	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephanie Wakefield	Newcastle Upon Tyne Hospital Trust	Principal Investigator
Nirouz Zarroug	Liverpool university Hospital Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nutrition and Dietetics		Liverpool			United Kingdom
Nutrition and Dietetics

IPD Sharing Statement Module

Plan to Share IPD

Description

Will upload the data as it becomes available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided