NCT03557671

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 23, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

May 14, 2018

Last Update Submit

November 3, 2020

Conditions

Cow Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • hypoallergenicity

    the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).

    7 days

Secondary Outcomes (18)

  • Regurgitations

    1, 2, 3, 4, 5 and 6 months

  • Vomiting

    1, 2, 3, 4, 5 and 6 months

  • Abdominal pain

    1, 2, 3, 4, 5 and 6 months

  • Bloating and gas

    1, 2, 3, 4, 5 and 6 months

  • Stool consistency

    1, 2, 3, 4, 5 and 6 months

  • +13 more secondary outcomes

Study Arms (2)

TRHF - Placebo

EXPERIMENTAL

Each subjects will receive both TRHF and placebo formula during the 1st part of the study

Dietary Supplement: rice formulaDietary Supplement: placebo

Placebo - TRHF

PLACEBO COMPARATOR

Each subjects will receive both TRHF and placebo formula during the 1st part of the study

Dietary Supplement: rice formulaDietary Supplement: placebo

Interventions

rice formulaDIETARY_SUPPLEMENT

new rice based thickened formula

Placebo - TRHFTRHF - Placebo
placeboDIETARY_SUPPLEMENT

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

Placebo - TRHFTRHF - Placebo

Eligibility Criteria

Age1 Month - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet);
  • whose parents signed the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHR Namur

Namur, Belgium

Location

Hôpital Saint Vincent de Paul - GHICL

Lille, 59000, France

Location

Hopital Trousseau

Paris, France

Location

University of Naples Federico II

Naples, Italy

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Roberto Berni Canani

    University Federico II

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 15, 2018

Study Start

August 23, 2018

Primary Completion

September 21, 2020

Study Completion

September 21, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

FR(2)IT(1)BE(1)