DisbiosisNCT05936541
Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants
A study testing Probiotic Bifidobacterium Bifidum PRL2010 in people with Disbiosis, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial summary
This study is aimed to manipulate the composition of the intestinal flora of the infants born by caesarian section through the administration of the probiotic strain "Bifidobacterium bifidum PRL 2010", in order to evaluate its effects on gut dysbiosis during the first 6 month of life. Read more about this study
- Who is it for?
- Ages 1 month to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Disbiosis
- What is being tested?
- Probiotic Bifidobacterium Bifidum PRL2010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jan 2020to 25 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants born by caesarian delivery
- Parents informed written consent
Who cannot join
- Suspension of the administration of the probiotic strain for a period of time exceeding 7 days
- Interruption of the administration of the probiotic strain before the completion of the sixth month
- Replacement of Bifidobacterium bifidum PRL2010 with another strain
- Refusal to collect the fecal sample expressed by parents
- Major congenital birth deformities
- Acute illness at enrollment
- Any condition affecting food intake or metabolism
- Maternal mental and psychosomatic diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site
Neonatology and Neonatal Intensive Care Unit of Santa Maria Goretti Hospital
Latina, LT 04100
About this study
This study is aimed to manipulate the composition of the intestinal flora of the infants born by caesarian section through the administration of the probiotic strain "Bifidobacterium bifidum PRL 2010", in order to evaluate its effects on gut dysbiosis during the first 6 month of life.
Read the detailed description
There has been increasing interest in the field of human microbiome, considering its impact on health and diseases. The gastrointestinal tract represents the most heavily inhabited organ with microorganisms, counting 10 times the total number of human cells; for this reason, the gut microbiome has recently been referred as a proper organ. Intestinal microbial composition is unique for each individual and it is influenced by numerous factors, of which delivery mode is an important one with gestational age of the newborn, type of feeding and intrapartum or neonatal antibiotic therapy. Recent reports suggest that dysbiosis secondary to delivery mode affects the subsequent regulation of immune response and may be associated with several pathologic conditions, for example allergic diseases or obesity. Moreover, gut microbiome seems to impact on neurodevelopment during first six months of life. Bifidobacteria is the most represented group of intestinal microbiota in the newborn, followed by Enterobacteria, and it plays an important role in the infant gut. This includes the fundamental function performed by Bifidobacterium bifidum: it supplies the nutritional material to the rest of the microbial community, particularly Bifidobacterium breve and Bifidobacterium longum infantis that are the other typical bifidobacteria of the newborn. It is a powerful metabolizer of the intestinal mucus and the HMOs (Human Milk Oligosaccharides) present in breast milk. Thanks to its exocitable enzymes, the degradative catabolism occurs in the intestinal environment. Thus, B. bifidum favour the increase in intestinal richness and biodiversity (9), which correlates with the host's state of health. However, bifidobacteria is reduced in infants born by cesarean delivery.
Aim of the study is to assess if the Bifidobacterium Bifidum PRL2010 supplementation effectively ameliorat bifidocentric dysbiosis due to the delivery mode and we want to confirm this by analyzing fecal microbiota in caesarean birth infants.
- Conditions
- Disbiosis
- Being tested
- Probiotic Bifidobacterium Bifidum PRL2010, Control group
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Bifidobacterium Bifidum PRL2010Dietary supplement
Probiotic supplement
Control groupOther
No probiotic supplementation
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Bifidobacterium Bifidum PRL2010 | Experimental | Participants in this group will receive probiotic Bifidobacterium Bifidum PRL2010 supplementation from the time of discharge to a daily for the 6 months Receives: Dietary Supplement: Probiotic Bifidobacterium Bifidum PRL2010 |
| Control | Active comparator | Participants in this group will not receive probiotic probiotic supplementation Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with disease
Number of participants with skin, respiratory and gastrointestinal diseases assessed with a questionnaire submitted to parents
Measured: up to 6 months
Secondary outcomes (1)
Variation in children gut microbiota composition
Variation in gut microbiota composition of children born by caesarean section assessed by faecal colonic microbiota analysis with 16S rRNA technology
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start5 Jan 2020
- Primary completion2 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Probiotic Bifidobacterium Bifidum PRL2010
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Santa Maria Goretti
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936541
- Sponsor's protocol ID
- 04-10/05/2022
- Status last verified
- Jul 2023
- First submitted
- 30 May 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants
- ClinicalTrials.gov ID
- NCT05936541
- Acronym / sponsor ID
- 04-10/05/2022
- Conditions
- Disbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Ospedale Santa Maria Goretti
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to manipulate the composition of the intestinal flora of the infants born by caesarian section through the administration of the probiotic strain "Bifidobacterium bifidum PRL 2010", in order to evaluate its effects on gut dysbiosis during the first 6 month of life.
Detailed description
There has been increasing interest in the field of human microbiome, considering its impact on health and diseases. The gastrointestinal tract represents the most heavily inhabited organ with microorganisms, counting 10 times the total number of human cells; for this reason, the gut microbiome has recently been referred as a proper organ. Intestinal microbial composition is unique for each individual and it is influenced by numerous factors, of which delivery mode is an important one with gestational age of the newborn, type of feeding and intrapartum or neonatal antibiotic therapy. Recent reports suggest that dysbiosis secondary to delivery mode affects the subsequent regulation of immune response and may be associated with several pathologic conditions, for example allergic diseases or obesity. Moreover, gut microbiome seems to impact on neurodevelopment during first six months of life. Bifidobacteria is the most represented group of intestinal microbiota in the newborn, followed by Enterobacteria, and it plays an important role in the infant gut. This includes the fundamental function performed by Bifidobacterium bifidum: it supplies the nutritional material to the rest of the microbial community, particularly Bifidobacterium breve and Bifidobacterium longum infantis that are the other typical bifidobacteria of the newborn. It is a powerful metabolizer of the intestinal mucus and the HMOs (Human Milk Oligosaccharides) present in breast milk. Thanks to its exocitable enzymes, the degradative catabolism occurs in the intestinal environment. Thus, B. bifidum favour the increase in intestinal richness and biodiversity (9), which correlates with the host's state of health. However, bifidobacteria is reduced in infants born by cesarean delivery.
Aim of the study is to assess if the Bifidobacterium Bifidum PRL2010 supplementation effectively ameliorat bifidocentric dysbiosis due to the delivery mode and we want to confirm this by analyzing fecal microbiota in caesarean birth infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Probiotic Bifidobacterium Bifidum PRL2010
| Arm | Type | Receives |
|---|---|---|
| Probiotic Bifidobacterium Bifidum PRL2010 | Experimental | Dietary Supplement: Probiotic Bifidobacterium Bifidum PRL2010Participants in this group will receive probiotic Bifidobacterium Bifidum PRL2010 supplementation from the time of discharge to a daily for the 6 months |
| Control | Active comparator | Other: Control groupParticipants in this group will not receive probiotic probiotic supplementation |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy infants born by caesarian delivery
- Parents informed written consent
Key exclusion criteria (8 listed)
- Suspension of the administration of the probiotic strain for a period of time exceeding 7 days
- Interruption of the administration of the probiotic strain before the completion of the sixth month
- Replacement of Bifidobacterium bifidum PRL2010 with another strain
- Refusal to collect the fecal sample expressed by parents
- Major congenital birth deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Bifidobacterium Bifidum PRL2010Probiotic supplement | Dietary supplement | Probiotic Bifidobacterium Bifidum PRL2010 |
| Control groupNo probiotic supplementation | Other | Control |
Primary outcome
Number of participants with disease
Time frame: up to 6 months
Number of participants with skin, respiratory and gastrointestinal diseases assessed with a questionnaire submitted to parents
1 secondary outcome
Variation in children gut microbiota composition
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Bifidobacterium Bifidum PRL2010 in people with Disbiosis, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with disease (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.