PaediatricTube feedNCT07378111
Vegetarian Tube Feed Study
A study testing paediatric tube feed in people with Paediatric, run by Société des Produits Nestlé (SPN).
Trial summary
This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Paediatric
- What is being tested?
- paediatric tube feed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 22 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients from 1 -15 years requiring more than 50% of energy from tube feeding or to take alongside home-made blended diet as part of their dietary management for disease related malnutrition.
- Patients well-established and stable on current nutritional support regimen. Willingly given, written, informed consent from patient/caregiver
Who cannot join
- No established tube feed.
- Inability to comply with the study protocol, in the opinion of the investigator.
- Under 1 years of age
- Patients on parenteral nutrition
- Known food allergies, including to any ingredients listed in appendix 1.
- Participation in another interventional study within 2 weeks of this study.
- Patients with known or suspected ileus or mechanical bowel obstruction
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acceptability (Including Gastrointestinal Tolerance, Compliance) of a Vegetarian Paediatric Enteral Tube Feed With Food Derived Ingredients.
This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients.
Read the detailed description
Acceptability (including gastrointestinal tolerance, compliance of a paediatric vegetarian tube feed with food derived ingredients. Gastrointestinal tolerance will data will be collected using a 4point Likert scale, daily record of tube feed volume intake.
- Conditions
- Paediatric
- Being tested
- paediatric tube feed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paediatric tube feedDietary supplement
500ml tube feed to be provided daily over 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Children will act as their own control for the nutritional product | Experimental | Gastrointestinal tolerance and daily formula intake over 28 days. Receives: Dietary Supplement: paediatric tube feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance and formula intake
Daily gastrointestinal tolerance measured using a 4 point Likert scale of none, mild, moderate, severe symptoms over days.
Measured: From enrolment to end of study over 28 days
Formula volume intake in mL
Formula intake measured daily in mLs over 28 days.
Measured: From enrolment to end of study over 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Mar 2026 (estimated)
- Primary completion7 Sep 2026 (estimated)
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PaediatricStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Graeme O'Connor, PHD, Principal investigator, Great Ormond Street Hospital Nutrition and Dietetics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378111
- Sponsor's protocol ID
- CPV tube feed PB002
- Other IDs
- IRAS ID 341165
- Acronym
- Tube feed
- Status last verified
- Mar 2026
- First submitted
- 8 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability (Including Gastrointestinal Tolerance, Compliance) of a Vegetarian Paediatric Enteral Tube Feed With Food Derived Ingredients.
- ClinicalTrials.gov ID
- NCT07378111
- Acronym / sponsor ID
- Tube feed / CPV tube feed PB002
- Conditions
- Paediatric
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 7 Sep 2026 (estimated)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 30 Jan 2026 (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.
This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients.
Detailed description
Acceptability (including gastrointestinal tolerance, compliance of a paediatric vegetarian tube feed with food derived ingredients. Gastrointestinal tolerance will data will be collected using a 4point Likert scale, daily record of tube feed volume intake.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children will act as their own control for the nutritional product | Experimental | Dietary Supplement: paediatric tube feedGastrointestinal tolerance and daily formula intake over 28 days. |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients from 1 -15 years requiring more than 50% of energy from tube feeding or to take alongside home-made blended diet as part of their dietary management for disease related malnutrition.
- Patients well-established and stable on current nutritional support regimen. Willingly given, written, informed consent from patient/caregiver
Key exclusion criteria (7 listed)
- No established tube feed.
- Inability to comply with the study protocol, in the opinion of the investigator.
- Under 1 years of age
- Patients on parenteral nutrition
- Known food allergies, including to any ingredients listed in appendix 1.
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 |
|---|---|---|
| paediatric tube feed500ml tube feed to be provided daily over 28 days. | Dietary supplement | Children will act as their own control for the nutritional product |
Primary outcome
Gastrointestinal tolerance and formula intake
Time frame: From enrolment to end of study over 28 days
Daily gastrointestinal tolerance measured using a 4 point Likert scale of none, mild, moderate, severe symptoms over days.
Formula volume intake in mL
Time frame: From enrolment to end of study over 28 days
Formula intake measured daily in mLs over 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Paediatric
RecruitingPhase 2
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Not yet recruiting
Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children
Anaesthetic Induction, Respiratory Complications of Care
RecruitingPhase 2
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
Colitis, Ulcerative
RecruitingPhase 3
Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse
Osteosarcoma, Pediatric Osteosarcoma
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.
Dr Graeme O'Connor, PHD principal investigator
Great Ormond Street Hospital Nutrition and Dietetics Department
Questions about this trial
What is this clinical trial studying?
A study testing paediatric tube feed in people with Paediatric, run by Société des Produits Nestlé (SPN).
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharan BSc (hons), Nutrition and Dietetics (+447557170649, sharan.saduera@uk.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal tolerance and formula intake (time frame: From enrolment to end of study over 28 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 12 Mar 2026.