Cow Milk AllergyNCT03557671
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins
A study testing rice formula in people with Cow Milk Allergy, run by United Pharmaceuticals at 4 sites in 3 countries.
Trial summary
The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA. Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- rice formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 23 Aug 2018to 21 Sep 2020
- 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 month to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion
- free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet);
- whose parents signed the informed consent
Who cannot join
- mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
Hôpital Saint Vincent de Paul - GHICL
Lille, 59000
Hopital Trousseau
Paris
About this study
Official title: Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins (TRHF 2017) in Children With Confirmed Immunoglobulin E (IgE) or Non-immunoglobulin E-mediated Cow's Milk Allergy (CMA)
The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.
Read the detailed description
The study is made of 2 different steps : 1st step is a double blind randomised food challenge where the new formula is compared to a placebo.
The second part of the trial consists in an open phase during which all infants will be fed with the study formula.
- Conditions
- Cow Milk Allergy
- Being tested
- rice formula, placebo
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rice formulaDietary supplement
new rice based thickened formula
placeboDietary supplement
formula previously tolerated by the subject - only for the 1st part of the study
| Study group | Role | What they receive |
|---|---|---|
| TRHF - Placebo | Experimental | Each subjects will receive both TRHF and placebo formula during the 1st part of the study Receives: Dietary Supplement: rice formula; Dietary Supplement: placebo |
| Placebo - TRHF | Placebo comparator | Each subjects will receive both TRHF and placebo formula during the 1st part of the study Receives: Dietary Supplement: rice formula; Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoallergenicity
the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).
Measured: 7 days
Secondary outcomes (18)
Regurgitations
assessed through Vandenplas score ranging from 0 (=less than 2 regurgitation episodes / day) to 6 (=Regurgitation of the complete volume after each feeding)
Measured: 1, 2, 3, 4, 5 and 6 months
Vomiting
(on a 4 level scale)
Measured: 1, 2, 3, 4, 5 and 6 months
Abdominal pain
(severity on a 4 level scale)
Measured: 1, 2, 3, 4, 5 and 6 months
Bloating and gas
(severity on a 4 level scale)
Measured: 1, 2, 3, 4, 5 and 6 months
Stool consistency
assessed through Bristol Stools Form Scale from Type A ( Separate hard lumps, like nuts (hard to pass)) to Type G (Watery, not solid pieces - entirely liquid )
Measured: 1, 2, 3, 4, 5 and 6 months
Stool frequency
(number of stool per day or per week)
Measured: 1, 2, 3, 4, 5 and 6 months
Blood in stools
(presence/absence)
Measured: 1, 2, 3, 4, 5 and 6 months
Sleeping time over 24h satisfaction
(presence/absence)
Measured: 1, 2, 3, 4, 5 and 6 months
Unexplained crying
(yes/no)
Measured: 1, 2, 3, 4, 5 and 6 months
Respiratory symptoms
(severity on a 4 level scale)
Measured: 1, 2, 3, 4, 5 and 6 months
Urticaria
(presence/absence)
Measured: 1, 2, 3, 4, 5 and 6 months
Angioedema
(presence/absence)
Measured: 1, 2, 3, 4, 5 and 6 months
Eczema
severity assessed through SCORAD
Measured: 1, 2, 3, 4, 5 and 6 months
Weight
expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards
Measured: 1, 2, 3, 4, 5 and 6 months
Height
expressed in cm and in z scores according to the WHO Child Growth Standards
Measured: 1, 2, 3, 4, 5 and 6 months
BMI
expressed in value and z scores according to the WHO Child Growth Standards
Measured: 1, 2, 3, 4, 5 and 6 months
Head circumference
expressed in cm and in z scores according to the WHO Child Growth Standards
Measured: 1, 2, 3, 4, 5 and 6 months
Number of patients with treatment emergent Adverse Events
Measured: 1, 2, 3, 4, 5 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start23 Aug 2018
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statitec
- Responsible party
- Sponsor
- Investigators
- Roberto Berni Canani, Study director, University Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557671
- Sponsor's protocol ID
- UP2017-Promyce
- Status last verified
- Nov 2020
- First submitted
- 14 May 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins (TRHF 2017) in Children With Confirmed Immunoglobulin E (IgE) or Non-immunoglobulin E-mediated Cow's Milk Allergy (CMA)
- ClinicalTrials.gov ID
- NCT03557671
- Acronym / sponsor ID
- UP2017-Promyce
- Conditions
- Cow Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Statitec
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 15 Jun 2018 (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 aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.
Detailed description
The study is made of 2 different steps : 1st step is a double blind randomised food challenge where the new formula is compared to a placebo.
The second part of the trial consists in an open phase during which all infants will be fed with the study formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRHF - Placebo | Experimental | Dietary Supplement: rice formula, Dietary Supplement: placeboEach subjects will receive both TRHF and placebo formula during the 1st part of the study |
| Placebo - TRHF | Placebo comparator | Dietary Supplement: rice formula, Dietary Supplement: placeboEach subjects will receive both TRHF and placebo formula during the 1st part of the study |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion
- free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet);
- whose parents signed the informed consent
Key exclusion criteria (1 listed)
- mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject
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 |
|---|---|---|
| rice formulanew rice based thickened formula | Dietary supplement | Placebo - TRHF, TRHF - Placebo |
| placeboformula previously tolerated by the subject - only for the 1st part of the study | Dietary supplement | Placebo - TRHF, TRHF - Placebo |
Primary outcome
hypoallergenicity
Time frame: 7 days
the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).
18 secondary outcomes
Regurgitations
Time frame: 1, 2, 3, 4, 5 and 6 months
Vomiting
Time frame: 1, 2, 3, 4, 5 and 6 months
Abdominal pain
Time frame: 1, 2, 3, 4, 5 and 6 months
Bloating and gas
Time frame: 1, 2, 3, 4, 5 and 6 months
Stool consistency
Time frame: 1, 2, 3, 4, 5 and 6 months
Stool frequency
Time frame: 1, 2, 3, 4, 5 and 6 months
Blood in stools
Time frame: 1, 2, 3, 4, 5 and 6 months
Sleeping time over 24h satisfaction
Time frame: 1, 2, 3, 4, 5 and 6 months
Unexplained crying
Time frame: 1, 2, 3, 4, 5 and 6 months
Respiratory symptoms
Time frame: 1, 2, 3, 4, 5 and 6 months
Urticaria
Time frame: 1, 2, 3, 4, 5 and 6 months
Angioedema
Time frame: 1, 2, 3, 4, 5 and 6 months
Eczema
Time frame: 1, 2, 3, 4, 5 and 6 months
Weight
Time frame: 1, 2, 3, 4, 5 and 6 months
Height
Time frame: 1, 2, 3, 4, 5 and 6 months
BMI
Time frame: 1, 2, 3, 4, 5 and 6 months
Head circumference
Time frame: 1, 2, 3, 4, 5 and 6 months
Number of patients with treatment emergent Adverse Events
Time frame: 1, 2, 3, 4, 5 and 6 months
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 4 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Roberto Berni Canani study director
University Federico II
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rice formula in people with Cow Milk Allergy, run by United Pharmaceuticals at 4 sites in 3 countries.
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 1 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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Belgium, Italy. 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. Some participants in this study may receive a placebo. 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?
hypoallergenicity (time frame: 7 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 4 Nov 2020.