NCT02711163

Brief Summary

The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

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

March 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

March 8, 2016

Last Update Submit

May 14, 2018

Conditions

Cow Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • Percentage of infants tolerating the formula during a double blind placebo controlled food challenge

    7 days

Secondary Outcomes (17)

  • Regurgitation assessed through Vandenplas score

    7, 45 and 90 days

  • Vomiting (weekly frequency)

    7, 45 and 90 days

  • Abdominal pain (severity on a 4 level scale)

    7, 45 and 90 days

  • Bloating and gas (severity on a 4 level scale)

    7, 45 and 90 days

  • Stool consistency assessed through Bristol Stools Form Scale

    7, 45 and 90 days

  • +12 more secondary outcomes

Study Arms (2)

Extensively hydrolyzed formula

EXPERIMENTAL

Feeding extensively hydrolyzed formula

Dietary Supplement: Extensively Hydrolyzed formula

Amino acid formula

PLACEBO COMPARATOR

Feeding amino acid formula

Dietary Supplement: Amino acid formula

Interventions

Extensively Hydrolyzed formulaDIETARY_SUPPLEMENT
Extensively hydrolyzed formula
Amino acid formulaDIETARY_SUPPLEMENT
Amino acid formula

Eligibility Criteria

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

You may qualify if:

  • Infants:
  • with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months,
  • successfully fed an eviction diet for at least 2 weeks
  • Infants:
  • fed with an extensively hydrolyzed formula with no improvement of the symptoms,
  • fed a vegetable based formula
  • fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations
  • who had an anaphylactic reaction in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umberto I university hospital

Roma, Italy

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Salvatore Cucchiara

    University Hospital Umberto I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

March 8, 2016

First Posted

March 17, 2016

Study Start

April 1, 2016

Primary Completion

August 31, 2017

Study Completion

November 29, 2017

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

IT(1)