- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06102135
Acceptability and Tolerance Study of Peptide Feed With Fibre
October 20, 2023 updated by: Société des Produits Nestlé (SPN)
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.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephanie Wakefield
- Phone Number: 4812 0191 282 3345
- Email: stephanie.wakefield3@nhs.net
Study Contact Backup
- Name: Sharan Saduera, BSc
- Phone Number: +447944513233
- Email: sharan.saduera@uk.nestle.com
Study Locations
-
-
-
Liverpool, United Kingdom
- Recruiting
- Nutrition and Dietetics
-
Contact:
- Nirouz Zarroug
-
Newcastle, United Kingdom
- Recruiting
- Nutrition and Dietetics
-
Contact:
- Stephanie Wakefield
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients well established on tube feeds will act as their own control
Patients in the control group will switch from current feed to new tube feed to assess tolerance and acceptability.
|
The amount of tube feed will be assess by the health Care Professional.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess tolerance via patient diaries
Time Frame: 14 days
|
Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating
|
14 days
|
Daily formula intake
Time Frame: 14 days
|
mL
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephanie Wakefield, Newcastle Upon Tyne Hospital Trust
- Principal Investigator: Nirouz Zarroug, Liverpool university Hospital Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2023
Primary Completion (Estimated)
September 21, 2024
Study Completion (Estimated)
September 21, 2024
Study Registration Dates
First Submitted
August 22, 2023
First Submitted That Met QC Criteria
October 20, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 20, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Peptide 003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Abstract and full publication in a nutrition and dietetic medical conference and journal
IPD Sharing Time Frame
End of study
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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