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New treatment option for Cerebral Palsy (CP)
Official title Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
ClinicalTrials.gov ID: NCT07341464
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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 treatment study within 2 weeks of this study.
- Patients with known or suspected ileus or mechanical bowel obstruction
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, United Kingdom
- Worcester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, United Kingdom; Worcester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.