Trial Outcomes & Findings for Milk Oral Immunotherapy in Children to Treat Food Allergy (NCT NCT01162473)

Last Updated: 2015-05-13

Results Overview

Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be "treatment failures". Subjects who completed the desensitization protocol were considered to be "treatment successes".

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

25 participants

Primary outcome timeframe

1 year

Results posted on

2015-05-13

Participant Flow

Children with a history of cow's milk allergy were referred from CHOP Allergy Clinics located in the main campus and satellite offices. Allergy and general pediatric practices in the greater Philadelphia area were also contacted by study staff as part of enrollment outreach.

Participant milestones

Participant milestones
Measure	Delayed Sensitivity All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.	Immediate Sensitivity All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
Overall Study STARTED	8	17
Overall Study COMPLETED	6	12
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Delayed Sensitivity All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.	Immediate Sensitivity All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	0	4

Baseline Characteristics

Milk Oral Immunotherapy in Children to Treat Food Allergy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delayed Sensitivity n=8 Participants All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.	Immediate Sensitivity n=17 Participants All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=99 Participants	17 Participants n=107 Participants	25 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	8.25 years n=99 Participants	8.88 years n=107 Participants	8.68 years n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	6 Participants n=107 Participants	9 Participants n=206 Participants
Sex: Female, Male Male	5 Participants n=99 Participants	11 Participants n=107 Participants	16 Participants n=206 Participants
Region of Enrollment United States	8 participants n=99 Participants	17 participants n=107 Participants	25 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The analysis population included all subjects who began desensitization per protocol.

Outcome measures

Outcome measures
Measure	Delayed Sensitivity n=8 Participants All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.	Immediate Sensitivity n=17 Participants All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
Number of Subjects Who Completed Desensitization Protocol	6 participants	12 participants

Adverse Events

Delayed Desensitization

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Immediate Desensitization

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Delayed Desensitization n=8 participants at risk Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder (42 week protocol).	Immediate Desensitization n=17 participants at risk Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder (29 week protocol)
Immune system disorders Anaphylaxis	25.0% 2/8 • Number of events 2 • 1 year Safety was assessed at all follow-up clinic visits. Adverse events encountered during the previous week, as documented on subjects' event journals, were reviewed. Full physical exams performed and vital signs were obtained. During desensitization, families were contacted every other day (first week) and then twice a week (weeks 2-6).	5.9% 1/17 • Number of events 1 • 1 year Safety was assessed at all follow-up clinic visits. Adverse events encountered during the previous week, as documented on subjects' event journals, were reviewed. Full physical exams performed and vital signs were obtained. During desensitization, families were contacted every other day (first week) and then twice a week (weeks 2-6).

Other adverse events

Other adverse events
Measure	Delayed Desensitization n=8 participants at risk Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder (42 week protocol).	Immediate Desensitization n=17 participants at risk Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder (29 week protocol)
Gastrointestinal disorders Abdominal Pain	12.5% 1/8 • Number of events 1 • 1 year Safety was assessed at all follow-up clinic visits. Adverse events encountered during the previous week, as documented on subjects' event journals, were reviewed. Full physical exams performed and vital signs were obtained. During desensitization, families were contacted every other day (first week) and then twice a week (weeks 2-6).	23.5% 4/17 • Number of events 4 • 1 year Safety was assessed at all follow-up clinic visits. Adverse events encountered during the previous week, as documented on subjects' event journals, were reviewed. Full physical exams performed and vital signs were obtained. During desensitization, families were contacted every other day (first week) and then twice a week (weeks 2-6).

Additional Information

Rushani W. Saltzman MD

The Children's Hospital of Philadelphia

Phone: 215-590-2549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place