Dietary ExposureNCT06102135
Acceptability and Tolerance Study of Peptide Feed with Fibre
A study testing Peptamen 1.3 PHGG in people with Dietary Exposure, run by Société des Produits Nestlé (SPN) at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- Peptamen 1.3 PHGG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Sep 2023to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nutrition and Dietetics
Liverpool
Nutrition and Dietetics
Newcastle
About this study
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.
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.
Read the 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.
- Conditions
- Dietary Exposure
- Being tested
- Peptamen 1.3 PHGG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptamen 1.3 PHGGDietary supplement
The amount of tube feed will be assess by the health Care Professional.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Peptamen 1.3 PHGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess tolerance via patient diaries
Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating
Measured: 14 days
Daily formula intake
mL
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start5 Sep 2023
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ExposureStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephanie Wakefield, Principal investigator, Newcastle Upon Tyne Hospital TrustNirouz Zarroug, Principal investigator, Liverpool university Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102135
- Sponsor's protocol ID
- Peptide 003
- Status last verified
- Oct 2023
- First submitted
- 22 Aug 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will upload the data as it becomes available
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06102135
- Acronym / sponsor ID
- Peptide 003
- Conditions
- Dietary Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients well established on tube feeds will act as their own control | Other | Dietary Supplement: Peptamen 1.3 PHGGPatients in the control group will switch from current feed to new tube feed to assess tolerance and acceptability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enterally fed adults feeding taking ≥60% of nutritional requirements from enteral nutrition
Key exclusion criteria (9 listed)
- Inability to comply with the study protocol, in the opinion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptamen 1.3 PHGGThe amount of tube feed will be assess by the health Care Professional. | Dietary supplement | Patients well established on tube feeds will act as their own control |
Primary outcome
Assess tolerance via patient diaries
Time frame: 14 days
Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating
Daily formula intake
Time frame: 14 days
mL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No. Will upload the data as it becomes available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Wakefield principal investigator
Newcastle Upon Tyne Hospital Trust
Nirouz Zarroug principal investigator
Liverpool university Hospital Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptamen 1.3 PHGG in people with Dietary Exposure, run by Société des Produits Nestlé (SPN) at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess tolerance via patient diaries (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.