Gastrointestinal InfectionsPhase 3NCT01909128
Fermented Milk and Fermented Rice on the Appearance of Respiratory and Gastrointestinal Symptoms
A Phase 3 study testing fermented milk and fermented rice in people with Gastrointestinal Infections and Respiratory Infections, run by Federico II University at 1 site in Italy.
Trial summary
The respiratory and gastrointestinal infections are a very common problem with high morbidity in children. These conditions were due, in general, immaturity and all "inexperience" of the immune system, as well as to the particular anatomical structure and function of the respiratory and gastrointestinal tract still… Read more about this study
- Who is it for?
- Ages 12 to 48 months
- Conditions the study is for
- Gastrointestinal Infections, Respiratory Infections
- What is being tested?
- fermented milk and fermented rice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Jun 2013
- Phase
- Phase 3
- 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 tuberculosis,
- congenital cardiac defects,
- autoimmune diseases,
- immunodeficiency,
- chronic inflammatory bowel diseases,
Show all 17Show fewer
- celiac diseases,
- cystic fibrosis,
- metabolic diseases,
- malignancy,
- chronic pulmonary diseases,
- malformation of the GI tract,
- history of allergy,
- severe wasting (less than 3 Standard deviations of weight-for-height z score),
- diarrhea on admission,
- antibiotic,
- pre/pro/symbiotic or immunostimulants use within 2 weeks before study start.
Trial locations and contacts
1 site in 1 country.
About this study
The respiratory and gastrointestinal infections are a very common problem with high morbidity in children. These conditions were due, in general, immaturity and all "inexperience" of the immune system, as well as to the particular anatomical structure and function of the respiratory and gastrointestinal tract still developing. This inevitably means that school-age children develop disease (as a result of infection) more easily than at later ages. The frequency and duration of these conditions implies a high discomfort and incur significant costs in relation to drug administration, the need for hospitalization, days of absence from school and work days lost by parents.
Recently probiotics, defined as "microorganisms that prove able, once ingested in adequate amounts, exert beneficial functions for the body "have been proposed for the treatment of treatment of respiratory and gastrointestinal infections of childhood but only in recent years have been conducted controlled clinical trials that have conclusively proven effectiveness. All probiotics induce an immune response, the characteristics of which are related to the strain or the mixture of bacteria used. Recent studies have demonstrated positive effects of probiotics on the respiratory system, and in particular on the prevention and reduction of the severity of respiratory infections, probably mediated by an increase of cells that secrete Immunoglobulin A in bronchial mucosa. It 'been shown that probiotics can be a sure way to reduce the risk of early acute otitis media and the use of antibiotics for recurrent respiratory infections during the first year of life. Similar results were seen in a study conducted on a population of 326 children aged between 3 and 5 years, who found a decrease in the incidence of antibiotic use by over 65% and a reduction of days of absence of more than 25% among children treated with a probiotic. Many of the studied effects of probiotics, understandably, refer to the digestive system. These effects relate to both conditions paraphysiological (constipation) and more specifically in situations of illness.
Read more
Most of the studies carried out in recent years has demonstrated the efficacy of specific probiotics in reducing the symptoms in the pediatric population affected by infectious gastroenteritis. Probiotics reduce the duration of infectious diarrhea by 0.7 days and reduce the frequency of diarrheal episodes in the first few hours.
The microbiota on the other hand participates in the function of the mucosal barrier against the adhesion of pathogenic bacteria, crucial time for the start of the infectious process.
When this barrier function is altered by chemical agents, by antigens or by stressors of different nature, may manifest intestinal disorders, sometimes due to the growth of bacteria pathogens. Numerous experimental data suggest that probiotics can contribute to the reinforcement of the activities of gut mucosal barrier, in particular aspects affecting the functionality of the intestinal epithelial cells or macrophages.
More recently it has been shown that daily intake for 3 months of preparation with probiotics reduce the incidence and severity of the most common respiratory infections and limits the number of days of absence school children during the winter season.
It's scientifically recognized as some probiotic effects can also be obtained with the use of inactivated bacteria or bacterial components isolated (eg bacterial DNA). It has been recently proposed a modified definition of probiotic products as "prepared bacterial cells or bacterial components that have a beneficial effect on the health and welfare of the host".
Among these products "probiotic-like" fall ingredients object of this study: food ingredients (rice flour and skim milk) fermented, or in which has been made to grow a probiotic (Lactobacillus CBA-L74) that has been inactivated at the end of the fermentation process through a heat treatment. The benefits are attributable to bacterial components that remain in the final product (for example, DNA, cell wall, etc.) and factors produced during the fermentation (short chain fatty acids, bacterial proteins, etc.).
The main effects of these bacterial components relate to the stimulation of the gastrointestinal tract associated lymphoid tissue (GALT), through interaction with the immune cells via Toll-like receptors.
In addition, some components, such as proteins and peptides, may have a Bifidogenic activity and are available in the literature some studies that have demonstrated the ability of infant formula, milk-based fermented to reduce the severity of episodes of infectious diarrhea in children.
With this data, the Commission of the European Society of Nutrition Gastroenterology, Hepatology and Pediatric Nutrition (ESPGHAN) has defined this type of products are not only safe but to determine a potential prebiotic effect and the reduction of the severity of episodes of infectious diarrhea.
- Being tested
- fermented milk, fermented rice
- Keywords
- children, fermented milk fermented rice, gastrointestinal infections, respiratory infections
- 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 CBA-L74
fermented riceDietary supplement
fermented rice wit Lactobacillus CBA-L74
| Study group | Role | What they receive |
|---|---|---|
| fermented milk | Experimental | Not described Receives: Dietary Supplement: fermented milk |
| fermented rice | Experimental | Not described Receives: Dietary Supplement: fermented rice |
| placebo | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of fermented milk and rice administered daily for a total duration of 3 months on the appearance of common respiratory and gastrointestinal infections in schoolchildren aged between 12 and 48 months.
fermented milk and fermented rice on the appearance of respiratory and gastrointestinal symptoms
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 posted26 Jul 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal InfectionsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 405 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909128
- Sponsor's protocol ID
- 210/12
- Status last verified
- Mar 2015
- First submitted
- 24 Jul 2013
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nocerino R, Paparo L, Terrin G, Pezzella V, Amoroso A, Cosenza L, Cecere G, De Marco G, Micillo M, Albano F, Nugnes R, Ferri P, Ciccarelli G, Giaccio G, Spadaro R, Maddalena Y, Berni Canani F, Berni Canani R. Cow's milk and rice fermented with Lactobacillus paracasei CBA L74 prevent infectious diseases in children: A randomized controlled trial. Clin Nutr. 2017 Feb;36(1):118-125. doi: 10.1016/j.clnu.2015.12.004. Epub 2015 Dec 17.
PubMed 26732025
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fermented Milk and Fermented Rice on the Appearance of Respiratory and Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT01909128
- Acronym / sponsor ID
- 210/12
- Keywords
- children, fermented milk fermented rice, gastrointestinal infections, respiratory infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Jul 2013 (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.
The respiratory and gastrointestinal infections are a very common problem with high morbidity in children. These conditions were due, in general, immaturity and all "inexperience" of the immune system, as well as to the particular anatomical structure and function of the respiratory and gastrointestinal tract still developing. This inevitably means that school-age children develop disease (as a result of infection) more easily than at later ages. The frequency and duration of these conditions implies a high discomfort and incur significant costs in relation to drug administration, the need for hospitalization, days of absence from school and work days lost by parents.
Recently probiotics, defined as "microorganisms that prove able, once ingested in adequate amounts, exert beneficial functions for the body "have been proposed for the treatment of treatment of respiratory and gastrointestinal infections of childhood but only in recent years have been conducted controlled clinical trials that have conclusively proven effectiveness. All probiotics induce an immune response, the characteristics of which are related to the strain or the mixture of bacteria used. Recent studies have demonstrated positive effects of probiotics on the respiratory system, and in particular on the prevention and reduction of the severity of respiratory infections, probably mediated by an increase of cells that secrete Immunoglobulin A in bronchial mucosa. It 'been shown that probiotics can be a sure way to reduce the risk of early acute otitis media and the use of antibiotics for recurrent respiratory infections during the first year of life. Similar results were seen in a study conducted on a population of 326 children aged between 3 and 5 years, who found a decrease in the incidence of antibiotic use by over 65% and a reduction of days of absence of more than 25% among children treated with a probiotic. Many of the studied effects of probiotics, understandably, refer to the digestive system. These effects relate to both conditions paraphysiological (constipation) and more specifically in situations of illness.
Most of the studies carried out in recent years has demonstrated the efficacy of specific probiotics in reducing the symptoms in the pediatric population affected by infectious gastroenteritis. Probiotics reduce the duration of infectious diarrhea by 0.7 days and reduce the frequency of diarrheal episodes in the first few hours.
The microbiota on the other hand participates in the function of the mucosal barrier against the adhesion of pathogenic bacteria, crucial time for the start of the infectious process.
When this barrier function is altered by chemical agents, by antigens or by stressors of different nature, may manifest intestinal disorders, sometimes due to the growth of bacteria pathogens. Numerous experimental data suggest that probiotics can contribute to the reinforcement of the activities of gut mucosal barrier, in particular aspects affecting the functionality of the intestinal epithelial cells or macrophages.
More recently it has been shown that daily intake for 3 months of preparation with probiotics reduce the incidence and severity of the most common respiratory infections and limits the number of days of absence school children during the winter season.
It's scientifically recognized as some probiotic effects can also be obtained with the use of inactivated bacteria or bacterial components isolated (eg bacterial DNA). It has been recently proposed a modified definition of probiotic products as "prepared bacterial cells or bacterial components that have a beneficial effect on the health and welfare of the host".
Among these products "probiotic-like" fall ingredients object of this study: food ingredients (rice flour and skim milk) fermented, or in which has been made to grow a probiotic (Lactobacillus CBA-L74) that has been inactivated at the end of the fermentation process through a heat treatment. The benefits are attributable to bacterial components that remain in the final product (for example, DNA, cell wall, etc.) and factors produced during the fermentation (short chain fatty acids, bacterial proteins, etc.).
The main effects of these bacterial components relate to the stimulation of the gastrointestinal tract associated lymphoid tissue (GALT), through interaction with the immune cells via Toll-like receptors.
In addition, some components, such as proteins and peptides, may have a Bifidogenic activity and are available in the literature some studies that have demonstrated the ability of infant formula, milk-based fermented to reduce the severity of episodes of infectious diarrhea in children.
With this data, the Commission of the European Society of Nutrition Gastroenterology, Hepatology and Pediatric Nutrition (ESPGHAN) has defined this type of products are not only safe but to determine a potential prebiotic effect and the reduction of the severity of episodes of infectious diarrhea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fermented milk | Experimental | Dietary Supplement: fermented milk |
| fermented rice | Experimental | Dietary Supplement: fermented rice |
| placebo | Placebo comparator | – |
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 (17 listed)
- concomitant chronic/congenital diseases and disabilities,
- active tuberculosis,
- 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 CBA-L74 | Dietary supplement | fermented milk |
| fermented ricefermented rice wit Lactobacillus CBA-L74 | Dietary supplement | fermented rice |
Primary outcome
Evaluate the efficacy of fermented milk and rice administered daily for a total duration of 3 months on the appearance of common respiratory and gastrointestinal infections in schoolchildren aged between 12 and 48 months.
Time frame: 3 months
fermented milk and fermented rice on the appearance of respiratory and gastrointestinal symptoms
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 19 Mar 2015.
- Derived from this study: PubMed 26732025Nocerino R, Paparo L, Terrin G, Pezzella V, Amoroso A, Cosenza L, Cecere G, De Marco G, Micillo M, Albano F, Nugnes R, Ferri P, Ciccarelli G, Giaccio G, Spadaro R, Maddalena Y, Berni Canani F, Berni Canani R. Cow's milk and rice fermented with Lactobacillus paracasei CBA L74 prevent infectious diseases in children: A randomized controlled trial. Clin Nutr. 2017 Feb;36(1):118-125. doi: 10.1016/j.clnu.2015.12.004. Epub 2015 Dec 17.
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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 Phase 3 study testing fermented milk and fermented rice in people with Gastrointestinal Infections and Respiratory Infections, run by Federico II University 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 17 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 19 Mar 2015. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluate the efficacy of fermented milk and rice administered daily for a total duration of 3 months on the appearance of common respiratory and gastrointestinal infections in schoolchildren aged between 12 and 48 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01909128, which also lists 1 linked publication.
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 19 Mar 2015.