Food HypersensitivityNCT03639337
Colonization and Persistence Capacity of a Multi-strain Probiotics in Pediatric Food Allergy to Milk or Egg.
A study testing Multi-strain probiotic in people with Food Hypersensitivity and Probiotic, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
This study evaluates the addition of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in the treatment of pediatric food allergic children to milk or egg. Read more about this study
- Who is it for?
- Ages 10 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Food Hypersensitivity, Probiotic
- What is being tested?
- Multi-strain probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Aug 2018
- 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 10 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 10 and 14 months
Who cannot join
- gastrointestinal disease in progress or appearance in the last 30 days
- metabolic diseases
- antibiotic treatment in the 2 weeks prior to the start of the study;
- intake of probiotic, fermented milk or other functional foods in the two weeks preceding the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Probiotics Bifidobacterium Longum, Bifidobacterium Breve and Bifidobacterium Infantis in Treating Pediatric Food Allergy to Milk or Egg.
This study evaluates the addition of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in the treatment of pediatric food allergic children to milk or egg. The allergic participants will receive the probiotics, while other two populations age and sex matched of not confirmed allergic and healthy children will not receive probiotics.
Read the detailed description
This study evaluates the colonization capacity of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in milk and/or egg allergic children.
It is expected the recruitment of about 20 egg and/or milk allergic patients aged between 10 and 14 months old confirmed with double-blind oral tolerance test against placebo (Group 1).
Furthermore, about 10 patients sensible to milk or egg but not confirmed with double-blind oral tolerance test against placebo (Group 2) will be recruited and about 10 healthy individuals (Group 3).
For all 40 patients:
- Baseline presence of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 will be evaluated; Only for Group 1 children it will be also evaluate:
- The presence of the same strains during 30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 and after 60 days from the suspension of the administration.
Quantification of B. breve, B. longum subsp. longum and B. longum subsp. infantis in faecal samples was carried out by qRT-PCR using the Light Cycler 480 platform (Roche Diagnostics, Mannheim, Germany). The assays were performed with a 20 µl PCR amplification mixture containing: 10 µl LightCycler 480 Probe Master mix (Roche Diagnostics), 2 µl primers and probes (optimized concentrations, 0.5 µM and 0.1 µM, respectively), 3 µl molecular-grade H2O and 5 µl DNA template. Each sample was tested in duplicate to ensure data reproducibility. The RT-PCR temperature profile consisted of an initial denaturation at 95°C for 10 min, 45 amplification cycles at 95°C for 10 sec, 60°C for 30 sec and 72°C for 1 sec followed by a final cooling step at 40°C for 30 sec. Absolute quantification was performed using the "second derivative maximum method"
Statistical analyses: Wilcoxon signed-rank test was used to compare probiotic species concentrations during the time-course.
- Conditions
- Food Hypersensitivity, Probiotic
- Being tested
- Multi-strain probiotic
- Keywords
- Probiotic, Food allergy
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-strain probioticDietary supplement
30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63
| Study group | Role | What they receive |
|---|---|---|
| Allergic Children | Experimental | Allergic children to milk or egg, aged between 10 and 14 months, confirmed by double-blind oral provocation test against placebo.
Intervention: 30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 Receives: Dietary Supplement: Multi-strain probiotic |
| Not confirmed Allergic Children | No intervention | Sensible children to milk or egg, aged between 10 and 14 months, not confirmed by double-blind oral provocation test against placebo. |
| Controls | No intervention | Healthy controls ages between 10 and 14 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V
It will be indicated number of cells per ul of stool.
Measured: 2 years
Secondary outcomes (1)
Stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V after multi-strain probiotic administration.
It will be indicated number of cells per ul of stool.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startJan 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HypersensitivityStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Giovanni Fiocchi, Bambino Gesù Hospital and Research Institute
- Investigators
- Alessandro Fiocchi, M.D., Principal investigator, agiovanni.fiocchi@opbg.net
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639337
- Sponsor's protocol ID
- 787_OPBG_2014
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Probiotics Bifidobacterium Longum, Bifidobacterium Breve and Bifidobacterium Infantis in Treating Pediatric Food Allergy to Milk or Egg.
- ClinicalTrials.gov ID
- NCT03639337
- Acronym / sponsor ID
- 787_OPBG_2014
- Conditions
- Food Hypersensitivity, Probiotic
- Keywords
- Probiotic, Food allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 21 Aug 2018 (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 evaluates the addition of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in the treatment of pediatric food allergic children to milk or egg. The allergic participants will receive the probiotics, while other two populations age and sex matched of not confirmed allergic and healthy children will not receive probiotics.
Detailed description
This study evaluates the colonization capacity of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in milk and/or egg allergic children.
It is expected the recruitment of about 20 egg and/or milk allergic patients aged between 10 and 14 months old confirmed with double-blind oral tolerance test against placebo (Group 1).
Furthermore, about 10 patients sensible to milk or egg but not confirmed with double-blind oral tolerance test against placebo (Group 2) will be recruited and about 10 healthy individuals (Group 3).
For all 40 patients:
- Baseline presence of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 will be evaluated; Only for Group 1 children it will be also evaluate:
- The presence of the same strains during 30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 and after 60 days from the suspension of the administration.
Quantification of B. breve, B. longum subsp. longum and B. longum subsp. infantis in faecal samples was carried out by qRT-PCR using the Light Cycler 480 platform (Roche Diagnostics, Mannheim, Germany). The assays were performed with a 20 µl PCR amplification mixture containing: 10 µl LightCycler 480 Probe Master mix (Roche Diagnostics), 2 µl primers and probes (optimized concentrations, 0.5 µM and 0.1 µM, respectively), 3 µl molecular-grade H2O and 5 µl DNA template. Each sample was tested in duplicate to ensure data reproducibility. The RT-PCR temperature profile consisted of an initial denaturation at 95°C for 10 min, 45 amplification cycles at 95°C for 10 sec, 60°C for 30 sec and 72°C for 1 sec followed by a final cooling step at 40°C for 30 sec. Absolute quantification was performed using the "second derivative maximum method"
Statistical analyses: Wilcoxon signed-rank test was used to compare probiotic species concentrations during the time-course.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allergic Children | Experimental | Dietary Supplement: Multi-strain probioticAllergic children to milk or egg, aged between 10 and 14 months, confirmed by double-blind oral provocation test against placebo. Intervention: 30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 |
| Not confirmed Allergic Children | No intervention | –Sensible children to milk or egg, aged between 10 and 14 months, not confirmed by double-blind oral provocation test against placebo. |
| Controls | No intervention | –Healthy controls ages between 10 and 14 months |
Who may qualify
- Ages
- 10 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age between 10 and 14 months
Key exclusion criteria (4 listed)
- gastrointestinal disease in progress or appearance in the last 30 days
- metabolic diseases
- antibiotic treatment in the 2 weeks prior to the start of the study;
- intake of probiotic, fermented milk or other functional foods in the two weeks preceding the start of the study.
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 |
|---|---|---|
| Multi-strain probiotic30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 | Dietary supplement | Allergic Children |
Primary outcome
Basal stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V
Time frame: 2 years
It will be indicated number of cells per ul of stool.
1 secondary outcome
Stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V after multi-strain probiotic administration.
Time frame: 2 years
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 28 Aug 2018.
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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.
Alessandro Fiocchi, M.D. principal investigator
agiovanni.fiocchi@opbg.net
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-strain probiotic in people with Food Hypersensitivity and Probiotic, run by Bambino Gesù Hospital and Research Institute 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 1 inclusion and 4 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 28 Aug 2018. 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?
Basal stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V (time frame: 2 years). 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 28 Aug 2018.