Cow Milk AllergyNCT03874104
Synbiotic Extensively Hydrolysed Feed Study
A study testing Extensively Hydrolysed Formula containing Pre- & Probiotics in people with Cow Milk Allergy, run by Nutricia UK Ltd at 8 sites in United Kingdom.
Trial summary
This study of the tolerance and acceptability of a extensively hydrolysed formula (eHF) containing pre- and probiotics will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged <13 months) currently using or requiring an extensively hydrolysed formula for the dietary management… Read more about this study
- Who is it for?
- Ages Up to 13 months
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Extensively Hydrolysed Formula containing Pre- & Probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 22 Aug 2018to 31 Jul 2023
- 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 Up to 13 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged <13 months
- Currently using or requiring an extensively hydrolysed formula for the dietary management of cows' milk allergy
- Expected to receive at least 25% of their energy intake from the study feed
- Already fed with infant formula or hypoallergenic formula (either partially or fully)
- Written, informed consent from parent/carer
Who cannot join
- "Severe" cows' milk allergy (clinically judged to require an amino acid formula) or any other contraindications to the use of an extensively hydrolysed formula
- Exclusively breastfed infants
- Primary lactose intolerance
- History of poor tolerance to whey based EHFs
- Immunocompromised infants
- Premature infants (born <37 weeks)
Show all 11Show fewer
- Major hepatic or renal dysfunction
- Requirement for any parenteral nutrition
- Tube-fed via a post-pyloric route
- Participation in other clinical intervention studies within 1 month of recruitment to this study
- Investigator concern around the ability of family to comply with protocol and requirements of study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Brighton and Sussex University Hospital NHS Foundation Trust
Brighton
University Hospitals Bristol NHS Foundation Trust
Bristol
Ashford and St Peter's Hospital NHS Foundation Trust
Chertsey
Royal Surrey County Hospital NHS Foundation Trust
Guildford
Guy's and St Thomas' NHS Foundation Trust
London
The Rotherham NHS Foundation Trust
Rotherham
university Hospitals Southampton NHS Foundation Trust
Southampton
West Hertfordshire NHS Foundation Trust
Watford
About this study
Official title: An Evaluation of the Tolerance and Acceptability of a Whey-based Extensively Hydrolysed Feed With Pre- and Probiotics, for the Dietary Management of Cows' Milk Allergy in Infants
This study of the tolerance and acceptability of a extensively hydrolysed formula (eHF) containing pre- and probiotics will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged <13 months) currently using or requiring an extensively hydrolysed formula for the dietary management of CMA. Patients already prescribed an eHF (or other appropriate feed for CMA) at time of recruitment will undertake a 3 day baseline period in which their current symptoms, compliance, GI tolerance and acceptability towards their current feed is assessed, before introducing the study product for a period of 4 weeks. Patients who are not on an eHF (or other appropriate feed for CMA) at baseline will forgo this 3 day baseline period and immediately introduce the study product for 4 weeks.
- Conditions
- Cow Milk Allergy
- Being tested
- Extensively Hydrolysed Formula containing Pre- & Probiotics
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensively Hydrolysed Formula containing Pre- & ProbioticsDietary supplement
Extensively Hydrolysed Formula containing Pre- and Probiotics
| Study group | Role | What they receive |
|---|---|---|
| Study product | Experimental | Extensively Hydrolysed Formula containing Pre- and Probiotics Receives: Dietary Supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire
Gastro-intestinal tolerance will be recorded by the parent on Baseline Days 1-3 (where this period is undertaken by the patient) and on Intervention Days 1, 2, 3, 7, 14, 21, 26, 27, and 28. Tolerance will be recorded using a standardised gastro-intestinal tolerance questionnaire, to be completed by the parents/carer
Measured: 31 days
Secondary outcomes (10)
Compliance
Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received. The amount prescribed by the Dietitian will be recorded at the start of the study, and any changes to this prescription also noted. During the baseline period (where this is undertaken) the compliance of the patient's usual feed will be assessed.
Measured: 31 days
Parent-reported Atopic Symptoms
Recorded via visual analogue scales at baseline and at the end of each week. Parents will record on a 100mm line the severity of a number of common atopic symtpoms, with the scale running from "not at all/none" at 0mm and "as bad as possible/
Measured: 31 days
Food Allergy QOL - Parental burden questionnaire
Measured at baseline and at the end of study via a Food Allergy QOL - Parental Burden Questionnaire
Measured: 31 days
Formula acceptability: Likert-style questionnaire
Feed acceptability will be assessed on Baseline Day 3 (for current feed, where applicable) and on the final day of the intervention period (Intervention day 28) via a Likert-style questionnaire
Measured: 31 days
Nutrient intake
Nutrient intake, including the intake of all nutrition provided (including the study product, any other enteral tube feeding, foods, drinks etc.) will be recorded via a 24hr dietary recall, conducted by the Dietitian at the Baseline Visit and at the End of Study Visit.
Measured: 31 days
Atopic dermatitis severity
Measured via Patient Orientated SCORing Atopic Dermatitis (PO-SCORAD) tool at Baseline, Intervention Day 7 and the final dat of the study
Measured: 31 days
Change in weight
Weight will be measured at the start and end of the study in kg
Measured: 31 days
Safety (Adverse Events)
Adverse events captured throughout entire study
Measured: 31 days
Change in length (cm)
Length will be measured at the start and end of the study
Measured: 31 days
Change in head circumference (cm)
Head circumference will be measured at the start and end of the study
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start22 Aug 2018
- Primary completion1 Dec 2021
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk AllergyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874104
- Sponsor's protocol ID
- PEPSYN001 V6
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2018
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Tolerance and Acceptability of a Whey-based Extensively Hydrolysed Feed With Pre- and Probiotics, for the Dietary Management of Cows' Milk Allergy in Infants
- ClinicalTrials.gov ID
- NCT03874104
- Acronym / sponsor ID
- PEPSYN001 V6
- Conditions
- Cow Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 14 Mar 2019 (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.
This study of the tolerance and acceptability of a extensively hydrolysed formula (eHF) containing pre- and probiotics will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged <13 months) currently using or requiring an extensively hydrolysed formula for the dietary management of CMA. Patients already prescribed an eHF (or other appropriate feed for CMA) at time of recruitment will undertake a 3 day baseline period in which their current symptoms, compliance, GI tolerance and acceptability towards their current feed is assessed, before introducing the study product for a period of 4 weeks. Patients who are not on an eHF (or other appropriate feed for CMA) at baseline will forgo this 3 day baseline period and immediately introduce the study product for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study product | Experimental | Dietary Supplement: Extensively Hydrolysed Formula containing Pre- & ProbioticsExtensively Hydrolysed Formula containing Pre- and Probiotics |
Who may qualify
- Ages
- Up to 13 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged <13 months
- Currently using or requiring an extensively hydrolysed formula for the dietary management of cows' milk allergy
- Expected to receive at least 25% of their energy intake from the study feed
- Already fed with infant formula or hypoallergenic formula (either partially or fully)
- Written, informed consent from parent/carer
Key exclusion criteria (11 listed)
- "Severe" cows' milk allergy (clinically judged to require an amino acid formula) or any other contraindications to the use of an extensively hydrolysed formula
- Exclusively breastfed infants
- Primary lactose intolerance
- History of poor tolerance to whey based EHFs
- Immunocompromised infants
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 |
|---|---|---|
| Extensively Hydrolysed Formula containing Pre- & ProbioticsExtensively Hydrolysed Formula containing Pre- and Probiotics | Dietary supplement | Study product |
Primary outcome
Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire
Time frame: 31 days
Gastro-intestinal tolerance will be recorded by the parent on Baseline Days 1-3 (where this period is undertaken by the patient) and on Intervention Days 1, 2, 3, 7, 14, 21, 26, 27, and 28. Tolerance will be recorded using a standardised gastro-intestinal tolerance questionnaire, to be completed by the parents/carer
10 secondary outcomes
Compliance
Time frame: 31 days
Parent-reported Atopic Symptoms
Time frame: 31 days
Food Allergy QOL - Parental burden questionnaire
Time frame: 31 days
Formula acceptability: Likert-style questionnaire
Time frame: 31 days
Nutrient intake
Time frame: 31 days
Atopic dermatitis severity
Time frame: 31 days
Change in weight
Time frame: 31 days
Safety (Adverse Events)
Time frame: 31 days
Change in length (cm)
Time frame: 31 days
Change in head circumference (cm)
Time frame: 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extensively Hydrolysed Formula containing Pre- & Probiotics in people with Cow Milk Allergy, run by Nutricia UK Ltd at 8 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire (time frame: 31 days). 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 27 Nov 2023.