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Trial record 65 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

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
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:

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

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


  2. Participant compliance [ Time Frame: Day 7 from baseline ]
    Volume of test product prescribed versus actually taken


Secondary Outcome Measures :
  1. Body weight [ Time Frame: Day 7 from baseline ]
    Weight will be measured in Kg



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Exclusively tube fed
  • Paediatrics aged 1 year above who require a low calorie feed
  • Children with Neurological impairment (NI) who require long term tube feeding
  • Patients established on a standard or peptide Enteral formula (no gastrointestinal intolerances on a current formula)
  • Willingly given, written, informed consent from patient or parent/guardian.
  • Willingly given, written assent (if appropriate).

Exclusion Criteria:

  • Inability to comply with the study protocol, in the opinion of the investigator
  • Known food allergies to any ingredients (see ingredients list)
  • Patients with significant renal or hepatic impairment
  • Participation in another interventional study within 2 weeks of this study.

Information from the National Library of Medicine

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


Contacts
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Contact: Sharan Saduera, BSc 07557170649 sharan.saduera@uk.nestle.com

Locations
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United Kingdom
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         
Gorton Clinic Recruiting
Manchester, United Kingdom, M12 5JY
Contact: Hayley Kuter, BHSc MA         
Sponsors and Collaborators
Nestlé

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03718208     History of Changes
Other Study ID Numbers: Low calorie 001
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases