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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paediatric formula | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paediatric Formula | Dietary Supplement | Children will switch over to the low calorie paediatric feed. Intake diaries and tolerance diaries will be completed for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance | 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 | Day 7 from baseline |
| Participant compliance | Volume of test product prescribed versus actually taken | Day 7 from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Weight will be measured in Kg | Day 7 from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clare Thornton-Wood, BSc | Dietitian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waldron Health Centre | Amersham | SE14 6LD | United Kingdom | |||
| Alexandra Children's Hospital |
Yes see details below
The study has been published in a journal
Avaliable on the internet
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Brighton |
| BN2 5BE |
| United Kingdom |
| Gorton Clinic | Manchester | M12 5JY | United Kingdom |