An interventional study of rice formula and placebo in Cow Milk Allergy, sponsored by United Pharmaceuticals. Completed at 4 sites in 3 countries. Open to participants aged 1 Month to 36 Months. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by United Pharmaceuticals · Not applicable, Interventional, and Treatment
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.
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 72 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →United Pharmaceuticals is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each subjects will receive both TRHF and placebo formula during the 1st part of the study
Dietary Supplement: rice formula · Dietary Supplement: placebo
Each subjects will receive both TRHF and placebo formula during the 1st part of the study
Dietary Supplement: rice formula · Dietary Supplement: placebo
new rice based thickened formula
formula previously tolerated by the subject - only for the 1st part of the study
hypoallergenicity
the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).
Time frame: 7 days
Regurgitations
assessed through Vandenplas score ranging from 0 (=less than 2 regurgitation episodes / day) to 6 (=Regurgitation of the complete volume after each feeding)
Time frame: 1, 2, 3, 4, 5 and 6 months
Vomiting
(on a 4 level scale)
Time frame: 1, 2, 3, 4, 5 and 6 months
Abdominal pain
(severity on a 4 level scale)
Time frame: 1, 2, 3, 4, 5 and 6 months
Bloating and gas
(severity on a 4 level scale)
Time frame: 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 )
Time frame: 1, 2, 3, 4, 5 and 6 months
Stool frequency
(number of stool per day or per week)
Time frame: 1, 2, 3, 4, 5 and 6 months
Blood in stools
(presence/absence)
Time frame: 1, 2, 3, 4, 5 and 6 months
Sleeping time over 24h satisfaction
(presence/absence)
Time frame: 1, 2, 3, 4, 5 and 6 months
Unexplained crying
(yes/no)
Time frame: 1, 2, 3, 4, 5 and 6 months
Respiratory symptoms
(severity on a 4 level scale)
Time frame: 1, 2, 3, 4, 5 and 6 months
Urticaria
(presence/absence)
Time frame: 1, 2, 3, 4, 5 and 6 months
Angioedema
(presence/absence)
Time frame: 1, 2, 3, 4, 5 and 6 months
Eczema
severity assessed through SCORAD
Time frame: 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
Time frame: 1, 2, 3, 4, 5 and 6 months
Height
expressed in cm and in z scores according to the WHO Child Growth Standards
Time frame: 1, 2, 3, 4, 5 and 6 months
BMI
expressed in value and z scores according to the WHO Child Growth Standards
Time frame: 1, 2, 3, 4, 5 and 6 months
Head circumference
expressed in cm and in z scores according to the WHO Child Growth Standards
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
Plan to share: Undecided
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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United Pharmaceuticals