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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 February 2025 |
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Main ID: |
NCT05051657 |
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Date of registration:
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10/09/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the Express Plus Range
express plus |
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Scientific title:
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A Study To Evaluate The Acceptability Of the Express Plus Range, Foods For Special Medical Purposes (FSMP), In Children And Adults With Inborn Errors of Metabolism (IEM) |
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Date of first enrolment:
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June 14, 2021 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05051657 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Anita MacDonald |
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Address:
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Telephone:
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Email:
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Affiliation:
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Birmingham Women's and Children's Hospital |
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Name:
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Anne Grimsley |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royal Belfast Hospital for Sick Children |
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Name:
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Clinical Trials Vitaflo |
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Address:
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Telephone:
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+44 (0) 151 709 9020 |
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Email:
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ClinicalTrialsTeam@Vitaflo.co.uk |
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Affiliation:
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Name:
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Barbara Cochrane |
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Address:
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Telephone:
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Email:
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Affiliation:
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Greater Glasgow and Clyde NHS Foundation Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of PKU or associated disorder for example, Tetrahydrobiopterin (BH4)
deficiency, requiring a low protein diet and Phe-free L-amino acid supplements
(protein substitute).
- Established on PKU express or an equivalent protein substitute
- In the opinion of the study investigator, the participant is able to take the study
product and meets at least one of the following criteria:
1. taking an age inappropriate protein substitute
2. struggling with adherence to current protein substitute
3. delayed in transitioning
- Aged 3 years and above
- Willingly given, written, informed consent from patient or parent/guardian.
- Willingly given, written assent (if appropriate).
Exclusion Criteria:
- Diagnosis of persistent hyperphenylalaninaemia, or mild PKU not requiring dietary
intervention with a low protein diet and protein substitute.
- Patients who are tube-fed.
- Individuals, who in the opinion of the investigator, are unable to comply with the
requirements of the protocol.
- Any co-morbidity/condition which in the opinion of the Investigator, would preclude
participation in the study.
- Patients who are currently participating in, plan to participate in, or have
participated in an interventional investigational drug, food or medical device trial
within 30 days prior to screening.
- Use of additional macro/micronutrient supplements during the study period, unless
clinically indicated and prescribed by the investigator (must be recorded in patient
case record file).
- Women who are pregnant / breastfeeding at the start of the study or planning to
become pregnant during the study period. (N.B.: Women who become pregnant
unexpectedly during this study may, in consultation with their doctor, continue on
the study's dietary product if they wish but will not have any investigations that
would not normally be carried out during pregnancy.)
- Those with allergies to fish, milk or soya.
Age minimum:
3 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Maple Syrup Urine Disease
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Phenylketonurias
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Homocystinuria
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Glutaric Acidemia I
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Hereditary Tyrosinemia
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PKU
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Intervention(s)
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Dietary Supplement: PKU express plus
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Primary Outcome(s)
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Change in gastrointestinal tolerance from week 1 to week 4
[Time Frame: Days 1-7 and days 21-28]
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Nutritional suitability: change Phenylalanine levels
[Time Frame: Visit 1 until visit 2 (day 28)]
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Change in food neophobia
[Time Frame: Visit 1 (Day 1) and Visit 2 (end of 28 day evaluation period)]
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Change in general neophobia
[Time Frame: Visit 1 (Day 1) and Visit 2 (end of 28 day evaluation period)]
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Nutritional suitability: change Tyrosine levels
[Time Frame: Visit 1 until visit 2 (day 28)]
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Questionnaire of self-reported adherence to the prescribed amount of study product
[Time Frame: Days 1-28]
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Product acceptability rated on a Likert scale by the patient after 28-day intake
[Time Frame: Visit 2 (end of 28 day evaluation period)]
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Transition time
[Time Frame: Transition period Weeks 1-6 (maximum)]
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Secondary ID(s)
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MCT-EXPP-2019-05-21
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20/YH/0248
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281995
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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