Acute GastroenteritisPhase 2NCT02367612
Fermented Milk on the Appearance of Common Winter Infectious Diseases
A Phase 2 study testing Fermented milk in people with Acute Gastroenteritis and Upper Respiratory Tract Infections, run by Federico II University at 3 sites in Italy.
Trial summary
Respiratory and gastrointestinal infections are common in children under the age of 4 years, especially after the start of schooling. These conditions are facilitated by a still incomplete functional maturation of the immune system and the anatomical structure and function of the respiratory and gastrointestinal tract… Read more about this study
- Who is it for?
- Ages 12 to 48 months
- Conditions the study is for
- Acute Gastroenteritis, Upper Respiratory Tract Infections
- What is being tested?
- Fermented milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 3 sitesItaly
- Study dates
- Dec 2014to Jun 2015
- Phase
- Phase 2
- 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 12 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 12-48 months attending educational program (either at nursery or primary school)
Who cannot join
- concomitant chronic/congenital diseases and disabilities
- active tubercolosis
- congenital cardiac defects
- autoimmune diseases
- immunodeficiency
- cystic fibrosis
Show all 14Show fewer
- metabolic diseases
- malignancy
- .chronic pulmonary diseases
- malformation of he GI tract
- food allergy
- antibiotic use
- pre/pro/symbiotic use
- severe wasting (less than 3 standard deviations of weight-for-height z score)
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Fabio Mosca
Milan
university of naples federico II
Naples, Naples, 80131
Giovanni Corsello
Palermo
About this study
Respiratory and gastrointestinal infections are common in children under the age of 4 years, especially after the start of schooling. These conditions are facilitated by a still incomplete functional maturation of the immune system and the anatomical structure and function of the respiratory and gastrointestinal tract still developing. The frequency and duration of these conditions involves a high discomfort and significant costs, in relation to medical appointments, taking medication, the need for hospitalization, days of absence from school and work days lost by parents. Functional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, with sometimes conflicting results. Diversity in experimental designs, populations evaluated, and bacterial strains used in the preparation of fermented products are probably responsible for these discrepancies. Recently we started a study approved by the Ethics Committee for Biomedical Activities "Carlo Romano" of the University of Naples "Federico II" (protocol number 210/12) to evaluate the effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of common winter infections in school children aged between 12 and 48 months. Studies of pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental colitis. A preliminary analysis of the data was found that subjects treated with fermented milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract infections or gastrointestinal, with a statistically significant difference between the study groups. It was also observed a significant increase in the levels of α- and β- defensins, LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to subjects treated with fermented rice or placebo.
Therefore, we decided to extend the period of study of five additional months, in order to perform an evaluation of the effectiveness of fermented milk (which was more effective)vs placebo.
- Being tested
- Fermented milk, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented milkDietary supplement
Fermented milk with Lactobacillus paracasei CBA L74
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Fermented milk | Experimental | Fermented milk with Lactobacillus paracasei CBA L74 Receives: Dietary Supplement: Fermented milk |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, Federico II University
- Investigators
- Roberto Berni Canani, MD, PhD, Study director, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367612
- Sponsor's protocol ID
- 210/12ES1
- Status last verified
- Jun 2015
- First submitted
- 12 Feb 2015
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fermented Milk on the Appearance of Common Winter Infectious Diseases
- ClinicalTrials.gov ID
- NCT02367612
- Acronym / sponsor ID
- 210/12ES1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Feb 2015 (estimated)
- 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.
Respiratory and gastrointestinal infections are common in children under the age of 4 years, especially after the start of schooling. These conditions are facilitated by a still incomplete functional maturation of the immune system and the anatomical structure and function of the respiratory and gastrointestinal tract still developing. The frequency and duration of these conditions involves a high discomfort and significant costs, in relation to medical appointments, taking medication, the need for hospitalization, days of absence from school and work days lost by parents. Functional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, with sometimes conflicting results. Diversity in experimental designs, populations evaluated, and bacterial strains used in the preparation of fermented products are probably responsible for these discrepancies. Recently we started a study approved by the Ethics Committee for Biomedical Activities "Carlo Romano" of the University of Naples "Federico II" (protocol number 210/12) to evaluate the effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of common winter infections in school children aged between 12 and 48 months. Studies of pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental colitis. A preliminary analysis of the data was found that subjects treated with fermented milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract infections or gastrointestinal, with a statistically significant difference between the study groups. It was also observed a significant increase in the levels of α- and β- defensins, LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to subjects treated with fermented rice or placebo.
Therefore, we decided to extend the period of study of five additional months, in order to perform an evaluation of the effectiveness of fermented milk (which was more effective)vs placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented milk | Experimental | Dietary Supplement: Fermented milkFermented milk with Lactobacillus paracasei CBA L74 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged 12-48 months attending educational program (either at nursery or primary school)
Key exclusion criteria (14 listed)
- concomitant chronic/congenital diseases and disabilities
- active tubercolosis
- congenital cardiac defects
- autoimmune diseases
- immunodeficiency
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 |
|---|---|---|
| Fermented milkFermented milk with Lactobacillus paracasei CBA L74 | Dietary supplement | Fermented milk |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract
Time frame: 3 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 25 Jun 2015.
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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.
Roberto Berni Canani, MD, PhD study director
Federico II University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fermented milk in people with Acute Gastroenteritis and Upper Respiratory Tract Infections, run by Federico II University at 3 sites 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 14 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 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract (time frame: 3 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 25 Jun 2015.