Trial · NCT07900594
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
NCT07900594, Not applicable, Not yet recruiting, Odense University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity. Trials, record NCT07900594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07900594
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
- NCT number
- NCT07900594
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Odense University Hospital
- Conditions
- Milk Allergy
- Interventions
- Basophil activation test, quality of life questionnaire
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The sensitivity and specificity of BAT | from enrollment to the oral food provocation test, approximately 2-6 months | To determine the performance of the BAT to predict the outcome of the Oral Food Challenge (reference standard) for children suspected of IgE-mediated CMA. The Oral Food challenge is the gold standard for diagnosing food allergy. It is a dichotomous variable (positive or negative). The sensitivity and the specificity of the BAT alone and BAT in combination with IgE will be calculated. |
| Secondary | The allergenicity of hydrolysate compared with Milk powder | from enrollment to the oral food provocation test, approximately 2-6 months | Using blood from sensitized infants, dose-response curves from BAT using hydrolysates will be compared with dose-response curves from BAT using milk powder |
| Secondary | The optimal allergen concentration for BAT | from enrollment to the oral food provocation test, approximately 2-6 months | Using the dose-response curve to determine if the standard manufacturer-recommended allergen concentration (22ng/ml) is the optimal for diagnosing food allergy |
| Secondary | QoL | from enrollment to the oral food provocation test, approximately 1-7 months | The quality of life (QoL) before the OFC will be compared with the QoL after the OFC using the validated questionnaire for children with food allergy: FAQLQ-PF |
| Secondary | The cost of a BAT compared with the cost of an oral food provocation | from enrollment to the oral food provocation test, approximately 2-6 months | A calculation of the potential economic gain by performing a BAT instead of an oral food provocation. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07900594
GET https://conductscience.org/api/trials/v1/NCT07900594/registered