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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A - 12 Months|
- - Infants of both sex.
- - Children older than one year.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Cow Milk Allergy|
Cow's-milk protein (CMP) is the leading cause of food allergy in infants and young children younger than 3 years (Sicherer SH.2011) (Rona RJ, et al. 2007).According to a recent meta-analysis, the self-reported lifetime prevalence of cow's milk protein allergy (CMPA)is 6% (range: 5.7-6.4) and the rate of CMPA prevalence defined by the food challenge was 0.6% (0.5-0.8) (Nwaru BI, etal. 2014).Earlier reports estimated an incidence of 2-3% in the first year of life (Høst A. 2002). CMPA can induce a diverse range of symptoms of variable intensity in infants . Immediate reactions (early) occur from minutes up to 2 hours after allergen ingestion and are more likely to be IgE mediated, whereas delayed reactions (late) manifest up to 48 hours or even 1 week following ingestion. The latter may also involve non-IgE-mediated immune mechanisms. Combinations of immediate and delayed reactions to the same allergen may occur in the same patient.(Shek LP, et al. 2005). Symptoms and signs related to CMPA may involve many different organ systems mostly the skin and the gastrointestinal and respiratory tracts. The involvement of two systems or more increases the probability of CMPA. Some symptoms are more likely to be present in children with a positive test for CMP-specific IgE (eg. Angioedema and atopic eczema); however, there is a large overlap. The same symptoms may appear in CMP IgE-positive and IgE-negative patients particularly in children with gastrointestinal manifestations (eg, allergic proctitis or proctocolitis) (Shek LP, et al. 2005). Due to the lack of other reliable diagnostic tests other than a food challenge with CM protein in infants suspected of suffering from cow's milk protein allergy (CMPA), an awareness tool has been developed to recognize cow's milk related symptoms in infants and young children for use by primary healthcare providers. It may help in increasing the awareness and the recognition of cow's milk related symptoms. This tool will help in making decisions and correct management. It would be appreciated by the parents because it will avoid both over and under-diagnosis and also shorten the duration of distress of the infants and parental anxiety. Delayed diagnosis of CMPA has a negative impact on the physical development of children (Robbins KA,et al. 2014) (Vieira MC, et al. 2010) A Cow's Milk-related-Symptom-Score (CoMiSS) is a score that considers general manifestations, dermatological gastrointestinal and respiratory symptoms. It was developed to be used as an awareness tool for cow's milk related symptoms . It can also be used to evaluate and quantify the evolution of symptoms during therapeutic interventions (Vandenplas Y, et al.2015) The CoMiSS score has been shown to be reliable tool in increasing awareness of primary health care physicians to more accurately suspect cow's-milk-related-symptoms.. The findings do suggest that a CoMiSS of ＞12 may be a good cut-off value to select infants presenting symptoms related to cow's milk protein. The results of the pooled analysis confirm that the CoMiSS may be a sensitive and specific awareness tool for health care professionals to select infants suspected to present with cow's milk related symptoms. A validation trail is still needed to use the score as a diagnostic tool. (YvanVandenplas,et al.2017)
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
For additional contact information, you can also visit the trial on clinicaltrials.gov.