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Completed

NCT Number: NCT03557671

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

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.

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Key information

Conditions

Cow Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

1 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Namur, Namur, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rice formula

Dietary Supplement

new rice based thickened formula

Placebo

Dietary Supplement

formula previously tolerated by the subject - only for the 1st part of the study

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Collaborators

  • Statitec

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 15, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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