Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.
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|ClinicalTrials.gov Identifier: NCT03718208|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae;
The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Dietary Supplement: Paediatric Formula||Not Applicable|
Patients well established and stable on a standard or peptide enteral tube feed will be changed to a low calorie 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.
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 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:||To Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Low Calorie Peptide Based Paediatric Tube-feed Formula; for Children Greater Than 1 Year of Age.|
|Actual Study Start Date :||August 8, 2018|
|Estimated Primary Completion Date :||December 10, 2018|
|Estimated Study Completion Date :||December 10, 2018|
Experimental: Paediatric formula
Each child will receive for a period of seven days. 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. One week intake diary, one week tolerance diary, product intake.
Dietary Supplement: Paediatric Formula
Children will switch over to the low calorie paediatric feed. Intake diaries and tolerance diaries will be completed for one week.
- Gastrointestinal tolerance [ Time Frame: Day 7 from baseline ]
Incidence of gastrointestinal adverse effects [ Time Frame: day 7 from baseline ].
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.
nausea, vomiting. burping, flatulence and regurgitation and abdominal discomfort or pain
- 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): NCT03718208
|Contact: Sharan Saduera, BScfirstname.lastname@example.org|
|Waldron Health Centre||Recruiting|
|Amersham, United Kingdom, SE14 6LD|
|Contact: Liesl Silbernagl|
|Alexandra Children's Hospital||Recruiting|
|Brighton, United Kingdom, BN2 5BE|
|Contact: Michelle Burke|
|Manchester, United Kingdom, M12 5JY|
|Contact: Hayley Kuter, BHSc MA|