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Trial record 2 of 7 for:    "Cow Milk Allergy" | "Immunoglobulins"

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

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ClinicalTrials.gov Identifier: NCT03557671
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Statitec
Information provided by (Responsible Party):
United Pharmaceuticals

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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)
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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




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 ]


Information from the National Library of Medicine

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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

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


Contacts
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Contact: Anne-Sophie Garreau 0033155372222 as.garreau@novalac.com

Locations
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Belgium
CHR Namur Not yet recruiting
Namur, Belgium
Principal Investigator: Elena Bradatan         
France
Hopital Trousseau Not yet recruiting
Paris, France
Principal Investigator: Patrick Tounian         
Sub-Investigator: Anais Lemoine         
Italy
University of Naples Federico II Recruiting
Naples, Italy
Principal Investigator: Roberto Berni Canani         
Sub-Investigator: Rita Nocerino         
Sub-Investigator: Carmen Discala         
Sponsors and Collaborators
United Pharmaceuticals
Statitec
Investigators
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Study Director: Roberto Berni Canani University Federico II

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Responsible Party: United Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03557671     History of Changes
Other Study ID Numbers: UP2017-Promyce
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
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