Child Nutrition DisordersESjNCT04488718
ESj- Powder Complete T&A Study
A study testing EnergieShake® Junior Powder Complete in people with Child Nutrition Disorders and Child Malnutrition, run by Anaiah Healthcare Pvt Ltd at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Child Nutrition Disorders, Child Malnutrition
- What is being tested?
- EnergieShake® Junior Powder Complete
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 24 Sep 2020to 24 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- >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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Brighton & Sussex NHS Trust
Brighton, BN2 5BE
Chris Smith
- Not yet recruiting
Leeds Children's Hospital,
Leeds, LS2 9NS
Jacqueline Lowdon
- Recruiting
Great Ormond Street Hospital Foundation Trust
London, WC1N 3JH
Graeme O'Connor
About this study
Official title: Evaluation of Tolerance and Acceptability of EnergieShake® Junior Powder Complete
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.
Read the detailed description
The goal of this study is to demonstrate the tolerance and acceptability of the test product when consumed by children who are currently prescribed (a similar) ONS. The data generated from this study will be submitted to the ACBS, who will consider it for reimbursement as a Food for Special Medical Purpose (FSMP) in the UK.
- Conditions
- Child Nutrition Disorders, Child Malnutrition
- Being tested
- EnergieShake® Junior Powder Complete
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnergieShake® Junior Powder CompleteOther
Oral Nutritional Supplement
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: EnergieShake® Junior Powder Complete |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start24 Sep 2020
- Primary completion24 Apr 2021 (estimated)
- Study completion24 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anaiah Healthcare Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brighton and Sussex University Hospitals NHS Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488718
- Sponsor's protocol ID
- ESj-01
- Acronym
- ESj
- Status last verified
- Feb 2021
- First submitted
- 20 Jul 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tolerance and Acceptability of EnergieShake® Junior Powder Complete
- ClinicalTrials.gov ID
- NCT04488718
- Acronym / sponsor ID
- ESj / ESj-01
- Conditions
- Child Nutrition Disorders, Child Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Anaiah Healthcare Pvt LtdIndustry (pharma, biotech, devices)
- Collaborators
- Brighton and Sussex University Hospitals NHS Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 24 Apr 2021 (estimated)
- Study completion
- 24 May 2021 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study is to demonstrate the tolerance and acceptability of the test product when consumed by children who are currently prescribed (a similar) ONS. The data generated from this study will be submitted to the ACBS, who will consider it for reimbursement as a Food for Special Medical Purpose (FSMP) in the UK.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EnergieShake® Junior Powder Complete (test) | Experimental | Other: EnergieShake® Junior Powder CompleteEnergieShake® 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). |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- >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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnergieShake® Junior Powder CompleteOral Nutritional Supplement | Other | EnergieShake® Junior Powder Complete (test) |
Primary outcome
Acceptability & Tolerance: questionnaire
Time frame: 7 days
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
Gastrointestinal Tolerance
Time frame: 7 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No. no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnergieShake® Junior Powder Complete in people with Child Nutrition Disorders and Child Malnutrition, run by Anaiah Healthcare Pvt Ltd at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elsa Brando (+44 01843448538, elsab@anaiahhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability & Tolerance: questionnaire (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021; AzTrials last refreshed its copy on 27 Oct 2026.