Childrens Real Food Tolerance Study
-
- STATUS
- Recruiting
-
- End date
- Dec 20, 2023
-
- participants needed
- 60
-
- sponsor
- Nutricia UK Ltd
Summary
A prospective, longitudinal, 28-day intervention study evaluating the tolerance, compliance, acceptability and safety to two new enteral tube feed and one new oral nutritional supplement based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement).
Description
Nutritional feeds in the form of either enteral tube feeds or oral nutritional supplements are commonly used to meet the entire or partial nutritional requirements of children who demonstrate faltering growth or other medical conditions where they cannot meet their nutritional requirements sufficiently either orally or with food alone. Prescribable commercially available enteral tube feeds and oral nutritional supplements are recommended for all patient groups by the National Institute for Clinical Excellence (NICE) and other professional bodies and are based on food ingredients such as milk powder, vegetable oils and vitamin/mineral mixes however, they are processed to some degree to ensure stability, sterility and standardised nutritional content.
In recent years some patient groups have begun to administer homemade blended foods via their feeding tubes, instead of using prescribable commercially available feeds, which is especially prevalent among paediatric patients. Although recognition of this practice from professional bodies is low, anecdotal evidence does show some benefits. Nonetheless, there are concerns with this practice including compromised nutritional consistency, microbiological safety and enteral pump and tube integrity. This presents a problem for some parents who wish to provide their child with a source of nutritional support based on real food without posing any additional risks. Nutricia has recognised the changing needs of these paediatric patients and has therefore extended its existing range of paediatric feeds to include new formulations which include real food ingredients whilst still maintaining sterility and a stabilised nutritional content. These new formulations are designed for children with faltering growth/disease related malnutrition from 1 year old, are suitable as a sole source of nutrition and provide a sterile, standardised consistency and nutritional content.
A clinical trial is therefore required to evaluate the tolerance, compliance, acceptability and safety of three new enteral tube feed and oral nutritional supplement formulations, based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement). Additional outcomes include nutritional intake, anthropometrics, and gastrointestinal health-related quality of life. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive the intervention feed(s) as a sole source of nutrition or alongside any additional routine nutritional management as required.
Details
| Condition | Malnutrition, Child |
|---|---|
| Treatment | Real food products |
| Clinical Study Identifier | NCT05269992 |
| Sponsor | Nutricia UK Ltd |
| Last Modified on | 20 June 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer