NCT07341464 Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
| NCT ID | NCT07341464 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Société des Produits Nestlé (SPN) |
| Condition | Cerebral Palsy (CP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2026-11-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-12-10 with a primary completion date of 2026-11-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants. The enteral bolus formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.
Eligibility Criteria
Inclusion Criteria: * Patients from 1 -15 years for children and 15 years and above for adults of requiring 1 or more bolus tube feed alongside their usual tube feed or home-made blended diet as part of their dietary management for disease related malnutrition. * Patients well-established and stable on current enteral tube feed or home-made blended diet. * Gastrostomy fed only. * Willingly given, written, informed consent from patient/caregiver Exclusion Criteria: * Inability to comply with the study protocol, in the opinion of the investigator. * Under 1 years of age * Patients who have a nasogastric and jejunal feeding tubes * Patients on total parenteral nutrition * Known food allergies to any ingredients listed in appendix 1. * Patients with significant renal or hepatic impairment * Participation in another interventional study within 2 weeks of this study. * Patients with known or suspected ileus or mechanical bowel obstruction
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07341464 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07341464 currently recruiting?
Yes, NCT07341464 is actively recruiting participants. Contact the research team at sharan.saduera@uk.nestle.com for enrollment information.
Where is the NCT07341464 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom, Worcester, United Kingdom.
Who is sponsoring the NCT07341464 clinical trial?
NCT07341464 is sponsored by Société des Produits Nestlé (SPN). The trial plans to enroll 50 participants.
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