Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Paediatric Tube-feed Formula Ingredients Derived From Real Food for Children Over 12 Months of Age
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|ClinicalTrials.gov Identifier: NCT03718195|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Child Nutrition Disorders||Other: Pediatric Formula||Not Applicable|
Patients well established and stable on a standard enteral tube feed will be changed to a paediatric formula for a period of seven days. This group will act as their own controls. Each child will receive for a period of seven days the paediatric formula, a nutritionally complete standard enteral tube feed.
The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. A baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms, current oral intake and weight at the start of the study.
The parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Paediatric Tube-feed Formula Ingredients Derived From Real Food for Children Over 12 Months of Age|
|Actual Study Start Date :||August 21, 2018|
|Estimated Primary Completion Date :||December 10, 2018|
|Estimated Study Completion Date :||December 10, 2018|
Each child will receive a new formula for a period of seven days. The new formula is a nutritionally complete standard enteral tube feed, with ingredients derived from real food. The formula is a food for special medical purposes for use under medical supervision.
The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube
Other: Pediatric Formula
One week intake diary, one week tolerance diary, product intake
- Gastrointestinal tolerance [ Time Frame: Day 7 from baseline ]Incidence of gastrointestinal adverse effects. Tolerance will be evaluated on the basis of the number of gastrointestinal events including diarrhea, constipation, bloating, distension, nausea, vomiting, burping, flatulence and regurgitation and abdominal discomfort or pain reported for subjects during their participation in the study.
- Participant compliance [ Time Frame: Day 7 from baseline ]Volume of test product prescribed versus actually taken
- Body Weight [ Time Frame: Day 7 from baseline ]Weight will be measured in Kg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718195
|Contact: Sharan Saduera, BScemail@example.com|
|Evelina Childrens Hospital||Not yet recruiting|
|London, United Kingdom, SE1 7EH|
|Contact: Rita Shergill-Bonner|
|Chelsea and Westminster Hospital||Recruiting|
|London, United Kingdom, SW10 9NH|
|Contact: Helen Stracey|
|Contact: Tamara Farrell|
|East Oxford Health Centre||Recruiting|
|Oxford, United Kingdom, OX4 1XD|
|Contact: Jayne Lewis|