ESj- Powder Complete T&A Study

NCT04488718 | Unknown

• 1 other identifier: ESj-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this study is to gather data on the tolerance and acceptability of a new ONS (ESj-powder complete) in children currently taking ONS.

Conditions

Child Nutrition Disorders; Child Malnutrition

Outcome Measures

Primary Outcomes (2)

• Acceptability & Tolerance: questionnaire

  Acceptability of test product will be tested in children using a questionnaire with a liking scale (Liking Scale - 1-10 - 0 being dislike and 10 being like a lot) and compliance (intake/day versus prescribed dose) of the test product over a 7 day period and compared to acceptability when consuming their current oral nutritional supplement

  7 days

• Gastrointestinal Tolerance

  Gastrointestinal (GI) tolerance of test product will be determined in children using a questionnaire detailing daily bowel habits and symptoms that occur (new or worsening) while consuming the test product over a 7 day period and compared to GI tolerance when consuming their current oral nutritional supplement. This is established using a combination of the Bristol Stool Chart scoring (BSC - type 1 up to type 7) before and during the study along with number of bowel movements/day and stool consistency.

  7 days

Study Arms (1)

EnergieShake® Junior Powder Complete (test)

EXPERIMENTAL

EnergieShake® Junior Powder Complete will be consumed by children, as a supplement to normal diet, over a period of 7 day period to determine its acceptability (liking, compliance) and tolerance (gastro-intestinal tolerance). The dose will be the same as currently consumed product (all children recruited to the study will be consuming an oral nutritional supplement).

Other: EnergieShake® Junior Powder Complete

Interventions

EnergieShake® Junior Powder Complete OTHER

Oral Nutritional Supplement

EnergieShake® Junior Powder Complete (test)

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \>1-18 years of age
• Children currently prescribed and consuming Oral Nutritional Supplements (ONS)
• Willingness to take part in the study, and consent to the study protocol signed by parent/guardian or older child (when appropriate)

You may not qualify if:

• Participants requiring exclusive enteral tube feeding
• Participants on parenteral nutrition
• Participants with cow's milk or soy allergy or lactose intolerance
• Participants with galactosaemia
• Participants with a chronic renal or liver disease
• Participants who are acutely unwell

Sponsors & Collaborators

• Anaiah Healthcare Pvt Ltd: lead
• Brighton and Sussex University Hospitals NHS Trust: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (3)

Brighton & Sussex NHS Trust

Brighton, BN2 5BE, United Kingdom

RECRUITING

Leeds Children's Hospital,

Leeds, LS2 9NS, United Kingdom

NOT YET RECRUITING

Great Ormond Street Hospital Foundation Trust

London, WC1N 3JH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Elsa Brando

CONTACT

+44 01843448538; elsab@anaiahhealthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 28, 2020
• Study Start: September 24, 2020
• Primary Completion: April 24, 2021
• Study Completion: May 24, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)