Acceptability, Gastrointestinal Tolerance, Compliance and... | NCT07210658

Studies
Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.

NCT07210658

Sponsor

Société des Produits Nestlé (SPN)

Status

Recruiting

Last Update Posted

Jan 9, 2026Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Paediatrics

Interventions

Oral nutritional supplementation

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2025Actual

Primary Completion Date

Nov 10, 2025Actual

Completion Date

May 15, 2026Estimated

First Submitted Date

Jul 23, 2025

First Submission Date that Met QC Criteria

Sep 29, 2025

First Posted Date

Oct 7, 2025Actual

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

Jan 8, 2026

Last Update Posted Date

Jan 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acceptability, compliance and palatability study.

Detailed Description

Acceptability (including gastrointestinal tolerance, compliance and palatability) of a paediatric oral nutritional supplement containing food blends.

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

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children will act as their own control for the nutritional product	Other		Dietary Supplement: Oral nutritional supplementation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral nutritional supplementation	Dietary Supplement	As directed by the HCP	Children will act as their own control for the nutritional product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastrointestinal tolerance	Number of children who experienced gastrointestinal symptoms such as reflux, vomiting, nausea, constipation, diarrhoea recorded as a 4 point Likert scale as none, mild, moderate, severe symptoms at baseline and at post switch.	Days 1-7, and at day 14, 21 and 28

Secondary Outcomes

Measure	Description	Time Frame
Formula intake in mLs	The amount of mLs of formula intake by patient compared to what was prescribed in mLs.	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients from 1-15 years requiring 1 or more oral nutritional supplement to replace current oral nutritional supplement 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.

Exclusion Criteria:

Unsafe swallow
Inability to comply with the study protocol, in the opinion of the investigator.
Under 1 years of age
Patients on total parenteral nutrition
Known food allergies, including any allergies to the ingredients
Patients with Chronic Kidney Disease (CKD) stage 3b (G3b), stage 4 (G4), stage 5 (G5) or hepatic impairment.
Participation in another interventional study within 2 weeks of this study.
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

1 Year

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sharan Saduera, BSc (Hons) Dietetics	Contact	+447557170649		sharan.saduera@uk.nestle.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dietetics	Recruiting	Nottingham			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019587	Dietary Supplements

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided