NCT06809465Completed
Effect of Probiotic Bifidobacterium Bifidum PRL 2010 in the Prevention of Atopic Dermatitis in Children
Effect of Supplementation of Probiotic Bifidobacterium Bifidum PRL2010) in Pregnancy for the Prevention of Atopic Dermatitis in Children: A Randomised, Double-blind, Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Feb 2025
Brief summary (registry, in English)
This study evaluates the effect of supplementation with Bifidobacterium bifidum PRL2010 during pregnancy in preventing atopic dermatitis in children. Pregnant women with a history of atopy or family history of allergies will be randomized to receive either the probiotic or a placebo. Outcomes include the incidence and severity of atopic dermatitis in infants up to 12 months of age.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 30 Jan 2025
- Start date
- 1 Sept 2022
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06809465
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 1 Sept 2022 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Infants with necrotizing enterocolitis or congenital, chronic, or metabolic diseases.
- Failure to meet any inclusion criteria during the study period.
Other
- Complications during pregnancy (e.g., preterm birth before 36 weeks).
- Immunodeficiencies in mother or child.
Who the study is looking for
- Pregnant women aged 18-45 years.
- Presence of allergic manifestations or a positive family history of allergies.
- Normal pregnancy without complications (e.g., no risk of eclampsia or gestational diabetes).
- Residing in Rome.
- Non-smoker and non-smoking partner.
- Absence of pets.
- Planning natural childbirth.
- Intention to breastfeed for at least 3 months.
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sapienza University of Rome, Department of Maternal Infantile and Urological Sciences, Division of Pediatric Allergology and Immunology Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.