NCT02719405

Brief Summary

Primary Endpoint

  • The percentage of subjects who develop tolerance to cow's milk protein by 12 months post randomization to study formula. Secondary Endpoints
  • Tolerance
  • The transcriptional profile of milk-specific T cells by clinical outcome.
  • Growth and Weight Velocity
  • Stool Consistency and Frequency
  • The estimated frequency of milk-specific T cells by clinical outcome.
  • The TCR diversity of milk-specific T cells by clinical outcome.
  • The milk allergen component-specific IgE, IgG4 and IgA by clinical outcome.
  • Safety
  • The rate of reported adverse events by treatment group.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

October 30, 2015

Last Update Submit

July 11, 2018

Conditions

Milk Allergy

Keywords

milkallergytolerance

Outcome Measures

Primary Outcomes (1)

  • The percentage of subjects who develop tolerance to cow's milk protein by 12 months post randomization to study formula.

    12 months post randomization

Secondary Outcomes (11)

  • Safety as assessed by adverse events graded using the NCI-CTCAE scale by treatment group.

    36 months

  • Tolerance as assessed by the transcriptional profile of milk-specific T cells by clinical outcome.

    36 months

  • Tolerance as assessed by weight for age Z-scores.

    36 months

  • Tolerance as assessed by length for age Z-scores.

    36 months

  • Tolerance as assessed by weight for length Z-scores.

    36 months

  • +6 more secondary outcomes

Study Arms (3)

Amino Acid Formula

PLACEBO COMPARATOR
Dietary Supplement: Amino Acid Formula

EHCF

ACTIVE COMPARATOR

Extensively Hydrolyzed Casein Formula

Dietary Supplement: Extensively Hydrolyzed Casein Formula

EHCF + LGG

ACTIVE COMPARATOR

Extensively Hydrolyzed Casein Formula + Lactobacillus GG

Dietary Supplement: Lactobacillus GGDietary Supplement: Extensively Hydrolyzed Casein Formula

Interventions

Lactobacillus GGDIETARY_SUPPLEMENT

Lactobacillus GG

EHCF + LGG
Extensively Hydrolyzed Casein FormulaDIETARY_SUPPLEMENT

Extensively Hydrolyzed Casein Formula

EHCFEHCF + LGG
Amino Acid FormulaDIETARY_SUPPLEMENT

Amino Acid Formula

Amino Acid Formula

Eligibility Criteria

AgeUp to 120 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants 0-120 days of age with suspected CMA, as determined by the pediatrician or specialist, will be referred to the study. A Standard Operating Procedures (SOP) document will be provided for the clinicians to help guide their referral to the study. Physician diagnosis of CMA will be based on the following:
  • Physician documented, gross or persistent microscopic blood in stool (3 positive guaiac cards on three separate stools) in the absence of other explanation (e.g., fissure, moderate-to-severe constipation) AND / OR
  • Infant with at least one gastrointestinal, dermatological, or respiratory allergic manifestation suggestive of CMA:
  • Gastrointestinal: Chronic Diarrhea, Constipation or Vomiting/Gastro-esophageal reflux
  • Dermatologic: Atopic Dermatitis or Urticaria
  • Respiratory: Cough, Allergic rhinitis or Recurrent Wheezing
  • General:Colic / Irritability
  • No change in treatment with medications during the 7 days preceding the elimination diet and no expected change in medications during the DBPCFCs (unless otherwise medically necessary)
  • Signed informed consent obtained for infants participation in the study
  • Signed authorization obtained to use and/or disclose Protected Health Information for infant from birth through the length of the study period
  • Caregiver(s) agree to comply with the infant elimination diet given to them by the investigator for the duration of the study
  • Mother agrees to follow an elimination diet throughout duration of breast feeding
  • Parent(s) or legally authorized representative agrees not to enroll infant in another interventional clinical study while participating in this study
  • Positive Double Blind Placebo Controlled Food Challenge (DBPCFC).

You may not qualify if:

  • History of anaphylaxis to milk
  • Use of probiotics
  • Use in the previous 4 weeks of systemic steroids
  • Use of systemic immunomodulatory treatment, including biologics with an immune target such as Xolair
  • Known eosinophilic GI disorders
  • Episode(s) of severe repetitive vomiting and lethargy prompting an emergency room visit and occurring within 4 hours of ingesting a milk protein (i.e. consistent with FPIES)
  • Co-existing autoimmune or other chronic disease or serious health problem, including celiac disease, inflammatory bowel disease, malignancy, congenital, metabolic or genetic disorders or malformations
  • Intention to exclusively breast feed
  • Infants born at less than 36 weeks gestation (35 weeks + 6 days is considered 35 weeks gestation)
  • Severe reaction to Milk Protein during the DBPCFC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Woburn Pediatric Associates

Woburn, Massachusetts, 01801, United States

Location

Related Publications (1)

  • Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

    PMID: 33006765DERIVED

MeSH Terms

Conditions

Milk HypersensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Wayne G Shreffler, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2015

First Posted

March 25, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 13, 2018

Record last verified: 2018-07

Locations

US(2)