Effect of Probiotic Bifidobacterium Bifidum PRL 2010 in the Prevention of Atopic Dermatitis in Children

January 30, 2025 updated by: Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Atopic dermatitis (AD) is a growing public health concern due to its increasing prevalence and significant impact on quality of life. This randomized, double-blind, placebo-controlled pilot study investigates the efficacy of Bifidobacterium bifidum PRL2010 in preventing AD when administered during pregnancy. Women aged 18-45 with a history of atopy or family history of allergies will be recruited and randomized into two groups: one receiving the probiotic and the other receiving a placebo. The intervention will begin at the 36th week of pregnancy and continue postpartum during breastfeeding for two months. Infants will subsequently receive the same treatment from the 3rd to 6th month of life. Outcomes include the presence and severity of AD assessed using the SCORAD index and additional allergy tests at 3, 6, and 12 months of age. This pilot aims to assess feasibility, safety, and initial efficacy data for future larger-scale studies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00161
        • Sapienza University of Rome, Department of Maternal Infantile and Urological Sciences, Division of Pediatric Allergology and Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Complications during pregnancy (e.g., preterm birth before 36 weeks).
  • Infants with necrotizing enterocolitis or congenital, chronic, or metabolic diseases.
  • Immunodeficiencies in mother or child.
  • Failure to meet any inclusion criteria during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotic Bifidobacterium bifidum PRL2010 (Bactopral®)
Participants in this arm will receive probiotic Bifidobacterium bifidum PRL2010 (Bactopral®) supplement. Each Bactopral®s sachet contains 1 billion CFU/sachet of the Bifidobacterium bifidum PRL2010. Mothers will take one sachet daily starting at the 36th week of pregnancy and continuing until delivery. During the first two months postpartum, mothers will continue daily doses. Infants will then receive the same probiotic from the 3rd to 6th month of life. Probiotic powder will be mixed with breast milk and administered via teaspoon or syringe.
Dietary supplement: Bactopral®
Oral Probiotic Bifidobacterium bifidum PRL2010 supplement
Placebo Comparator: Placebo
Participants in this arm will receive a placebo identical in appearance, smell, and taste to the probiotic. The placebo contains bacteria-free maltodextrins. Administration will follow the same schedule as the probiotic arm.
Other: Plcebo
Oral placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Atopic Dermatitis in Infants
Time Frame: 12 months from birth
The presence of atopic dermatitis in infants will be evaluated using the SCORAD index at 3, 6, and 12 months of age.
12 months from birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liaquat University of Medical & Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Università degli Studi dell'Insubria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ref. 6205/Sapienza University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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