NCT04488718|Unknown
ESj- Powder Complete T&A Study
ESj
Evaluation of Tolerance and Acceptability of EnergieShake® Junior Powder Complete
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ESj
Evaluation of Tolerance and Acceptability of EnergieShake® Junior Powder Complete
Sponsor study identifier
interventional
18
1 country
3
Study Start
September 24, 2020
Actual (reported)Primary Completion
April 24, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 24, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 24, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2020
Actual (reported)July 28, 2020
Actual (reported)September 24, 2020
Actual (reported)April 24, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 24, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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).
Oral Nutritional Supplement
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Brighton & Sussex NHS Trust
Brighton, BN2 5BE, United Kingdom
Leeds Children's Hospital,
Leeds, LS2 9NS, United Kingdom
Great Ormond Street Hospital Foundation Trust
London, WC1N 3JH, United Kingdom
First Submitted
July 20, 2020
First Posted
July 28, 2020
Study Start
September 24, 2020
Actual (reported)Primary Completion
April 24, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study of Malnutrition in Primary School Children
Contact the study team to confirm eligibility.
Study Completion
May 24, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 3, 2021
Record last verified: 2021-02
no plan
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Source: ClinicalTrials.gov.
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