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Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03557671
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Statitec
Information provided by (Responsible Party):
United Pharmaceuticals

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cow Milk Allergy Dietary Supplement: rice formula Dietary Supplement: placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 23, 2018
Actual Primary Completion Date : September 21, 2020
Actual Study Completion Date : September 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: TRHF - Placebo
Each subjects will receive both TRHF and placebo formula during the 1st part of the study
 Dietary Supplement: rice formula
new rice based thickened formula

Dietary Supplement: placebo
formula previously tolerated by the subject - only for the 1st part of the study
Placebo Comparator: Placebo - TRHF
Each subjects will receive both TRHF and placebo formula during the 1st part of the study
 Dietary Supplement: rice formula
new rice based thickened formula

Dietary Supplement: placebo
formula previously tolerated by the subject - only for the 1st part of the study


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Regurgitations [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    assessed through Vandenplas score ranging from 0 (=less than 2 regurgitation episodes / day) to 6 (=Regurgitation of the complete volume after each feeding)

  2. Vomiting [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (on a 4 level scale)

  3. Abdominal pain [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (severity on a 4 level scale)

  4. Bloating and gas [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (severity on a 4 level scale)

  5. Stool consistency [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    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 )

  6. Stool frequency [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (number of stool per day or per week)

  7. Blood in stools [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (presence/absence)

  8. Sleeping time over 24h satisfaction [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (presence/absence)

  9. Unexplained crying [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (yes/no)

  10. Respiratory symptoms [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (severity on a 4 level scale)

  11. Urticaria [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (presence/absence)

  12. Angioedema [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    (presence/absence)

  13. Eczema [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    severity assessed through SCORAD

  14. Weight [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards

  15. Height [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    expressed in cm and in z scores according to the WHO Child Growth Standards

  16. BMI [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    expressed in value and z scores according to the WHO Child Growth Standards

  17. Head circumference [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]
    expressed in cm and in z scores according to the WHO Child Growth Standards

  18. Number of patients with treatment emergent Adverse Events [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557671


Locations
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Belgium
CHR Namur
Namur, Belgium
France
Hôpital Saint Vincent de Paul - GHICL
Lille, France, 59000
Hopital Trousseau
Paris, France
Italy
University of Naples Federico II
Naples, Italy
Sponsors and Collaborators
United Pharmaceuticals
Statitec
Investigators
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Study Director: Roberto Berni Canani University Federico II
More Information
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Responsible Party: United Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03557671    
Other Study ID Numbers: UP2017-Promyce
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate