Isıl İşlem Görmüş Lactobacillus Paracasei (GM080) Tüketiminin Atopik Dermatit Üzerindeki Etkinliğinin Değerlendirilmesi

Sade dilde özet

Bu çalışma, ısıl işlem görmüş bir probiyotiğin (GM080) maltodekstrine kıyasla bebeklerde atopik dermatit (atopic dermatitis), yani egzama belirtilerine iyi gelip gelmediğini değerlendirmektedir. Çalışmaya, hafif ile şiddetli arası atopik belirtileri (SCORAD ≥20) olan 4-30 aylık bebekler katılabilmiştir. Çalışma faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Tamamlandı

Sponsor

Société des Produits Nestlé (SPN)

Müdahale

GM080, Maltodextrin

Başlangıç

01.07.2014

Tahmini bitiş

01.11.2017

Ülkeler

Taiwan

İlgili genler

Merkezler

• Kaohsiung City, Taiwan
• Kaohsiung City, Taiwan
• Taipei, Taiwan
• Taichung, Taiwan
• Gueishan Township, Taiwan
• New Taipei City, Taiwan

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Infants aged from 4-30 months (inclusive) at the time of enrolment (63 in each group).
* With mild to severe atopic symptoms: SCORAD ≥ 20 (at V0b).
* Having obtained his/her (or his/her legal representative's) written Informed Consent.

Exclusion Criteria:

* SCORAD inferior to 20 (SCORAD less than 20 at V0b). A SCORAD less than 20 at V0c is not an exclusion criteria.
* Infants who need a systemic treatment for their skin condition (e.g. glucocorticoids, steroids, cyclosporine A).
* Infants or mothers who introduce probiotics (other than the study product) in their diet during the 16-weeks intervention study. Of note: Infants or mothers who are used to consume a certain probiotic for more than 1 month before the start of the study (V0b), can continue to use this probiotic during the intervention period and will not be excluded. Recent introduction of probiotics, within a month before the planned start of the study (V0b) should be stopped and recorded; at least 1 month should be between stopping the consumption of the probiotic and V0b).
* Infants having other inflammatory skin diseases (urticaria, psoriasis).
* Infants having a congenital illness or malformation that may affect normal growth (especially immunodeficiency).
* Infants whose parents/caregivers cannot be expected to comply with the study procedures.
* Infants currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
* Infants using topical calcineurin inhibitors (e.g. tacrolimus and pimecrolimus (ELIDEL®)) during the study.
* Infants who have undergone in the month before the start of the study (V0b), are currently undergoing or are anticipated to undergo ultraviolet light therapy or wet dressing or any other topical treatment of their eczema other than the one provided in the study. Lotion and skin moisturizer are allowed but need to be monitored for frequency and area.
* The investigator and clinician will assess if the child has to be excluded based on the patient's medical condition and taken into account the values of the safety parameters tested. Therefore, no cut-off values, or normal ranges for the different safety parameters are exclusion criteria. It will be the responsibility of the investigator and clinician, based on their medical judgement, to decide if it is safe or not to include an infant into the study.