Upper Respiratory Tract InfectionsFERCT19NCT05484102
Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Common Infectious Diseases in Children
A study testing milk fermented with lactobacillus paracasei CBA L74 in people with Upper Respiratory Tract Infections and Gastrointestinal Infection, run by University of Bari at 1 site in Italy.
Trial summary
this is a double-blind randomized placebo controlled clinical trial. 200 healthy children aged 12-48 months, attending day care or preschool for at least 5 days a week, regularly checked by the family pediatrician (FP) involved in the trial, were considered for the study and consecutively contacted during scheduled… Read more about this study
- Who is it for?
- Ages 12 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections, Gastrointestinal Infection, Children, Only
- What is being tested?
- milk fermented with lactobacillus paracasei CBA L74
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2022to 11 Jan 2024
- 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 12 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 12-48 months
- attending day care or preschool for at least 5 days a week
Who cannot join
- The exclusion criteria were:
- age <12 months or >48 months
- concomitant chronic infections, chronic systemic diseases, chronic inflammatory bowel diseases, autoimmune diseases, immunodeficiency, malignancy, metabolic diseases
- chronic respiratory tract diseases including respiratory allergies and cystic fibrosis
- malformations of gastrointestinal or urinary or respiratory tract
- history of respiratory or gastrointestinal or urinary tract surgery
Show all 12Show fewer
- congenital cardiac defects
- functional bowel disorders
- suspected or challenge-proved food allergy, food intolerances
- severe malnutrition (z-score for weight-for-height <3 standard deviation scores)
- use of antibiotics or pre/pro/synbiotics or immune stimulating products in the 2 weeks before the enrolment
- Siblings of subjects enrolled in the study were not allowed to participate to the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Upper Respiratory Tract and Gastrointestinal Infectious Diseases in Children: a Double-blind, Randomized, Placebo-controlled Trial
this is a double-blind randomized placebo controlled clinical trial. 200 healthy children aged 12-48 months, attending day care or preschool for at least 5 days a week, regularly checked by the family pediatrician (FP) involved in the trial, were considered for the study and consecutively contacted during scheduled medical examinations at the FPs office. study plan is 3-month treatment period. The clinical evaluation will be carried out at enrollment, at 30, 60 and 90 days from the beginning of the treatment by the pediatrician. fecal and nasal mucus samples for immunological and microbiological analysis will be collected before the treatment and at 90 days (end of treatment).
Read the detailed description
Subjects were supplemented daily for 3 months with cow's skim milk fermented with L. paracasei CBA L74 (group A) or placebo (group B).Enrolled children will be randomly assigned, with the use of a computer-generated randomization list to receive either milk fermented with Lactobacillus paracasei CBA L74 or placebo once. Placebo and fermented milk had the same shape, the placebo's taste, dimension, indication, and appearance. At enrollment the family pediatricians consulted the clinical records of each child for previous diseases and pharmacological treatments. At the baseline, after obtaining informed consent from the parents/tutors of each child, the health status of all the study subjects was carefully assessed, and the presence of infectious diseases or other disease was ruled out by means of a complete physical examination, including vital signs (body temperature, pulse rate, respiration rate, blood pressure); neurological status; body growth status; nutritional status; hydration; skin evaluation; otoscopy; evaluation of oral cavity; respiratory/abdomen/lymphonode examination; and genital examination.
A diary will be given to the parents; on a daily basis, patients will monitor and record the frequency/severity of symptoms, episodes of respiratory and/or gastrointestinal infection and their duration and school absence on the diary.
Fecal Analysis: three fecal samples for microbiological and immunological analysis will be collected before treatment and at 90 days (end of treatment). Nasal mucus samples for immunological analysis will be collected before the treatment and at 90 days (end of the treatment).
The study was approved by the Ethics Committee of the Universities of Bari.
- Being tested
- milk fermented with lactobacillus paracasei CBA L74, placebo milk formula
- Keywords
- Lactobacillus paracasei CBA L74, fermented milk
- 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.
milk fermented with lactobacillus paracasei CBA L74Dietary supplement
milk fermented with lactobacillus paracasei CBA L74 will be administered daily for 3 months to 100 children. Participants were supplied with the milk product in powder form, by Heinz Italia SpA, Segrate, Italy. The study products were provided in tins containing 400 g of powder, and the packaging was similar and the tins were stored at room temperature in a dry environment. The family pediatricians instructed parents about the daily amount of the assigned study product and the method of preparation. All subjects received 7 g/day of study products diluted in a maximum of 150 mL of cow's milk or water. After dilution, the look and the taste were the same for all of the study products.
placebo milk formulaDietary supplement
placebo milk formula containing maltodextrins will be administered daily for 3 months to 100 children. The study products were provided in tins containing 400 g of powder, and the packaging was similar and the tins were stored at room temperature in a dry environment. The family pediatricians instructed parents about the daily amount of the assigned study product and the method of preparation. All subjects received 7 g/day of study products diluted in a maximum of 150 mL of cow's milk or water. After dilution, the look and the taste were the same for all of the study products.
| Study group | Role | What they receive |
|---|---|---|
| lactobacillus paracasei CBA L74 | Experimental | 100 enrolled children will receive milk fermented with lactobacillus paracasei CBA L74 daily for 3 months. Receives: Dietary Supplement: milk fermented with lactobacillus paracasei CBA L74 |
| placebo | Placebo comparator | 100 enrolled children will receive placebo milk formula containing maltodextrins daily for 3 months. Receives: Dietary Supplement: placebo milk formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
preventive effect of cow's milk fermented with Lactobacillus paracasei CBA L74 on common infectious disease
the rate of children experiencing at least one episode of common infectious disease
Measured: 3 months
Secondary outcomes (5)
Total number of common infectious disease
evaluate the total number of common infectious disease
Measured: 3 months
use of medications
use of medications (antibiotics, antipyretics, steroids)
Measured: 3 months
emergency department medical examinations and hospitalizations
access to emergency department medical examinations and hospitalizations
Measured: 3 months
days of work lost by the parents
evaluation of days of work lost by the parents
Measured: 3 months
days of school lost by the children
evaluation of days of school lost by the children
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 posted2 Aug 2022
- Study start15 Sep 2022
- Primary completion10 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized placebo controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Heinz Italia SpA
- Responsible party
- Principal investigator, Ruggiero Francavilla, University of Bari
- Investigators
- ruggiero francavilla, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484102
- Sponsor's protocol ID
- FERCT19
- Acronym
- FERCT19
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators were blinded to the treatment at all times (i.e., allocation, intervention, laboratory analysis and statistical analysis). The study subjects were allocated to two groups (group A or group B) according to a computer-generated randomization list. The pediatricians, parents, and the children were blinded to the allocated treatment. Subjects were supplemented daily for 3 months with cow's skim milk fermented with L. paracasei CBA L74 (group A) or placebo (group B).
Publications
Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18.
PubMed 21873895Tamang JP, Shin DH, Jung SJ, Chae SW. Functional Properties of Microorganisms in Fermented Foods. Front Microbiol. 2016 Apr 26;7:578. doi: 10.3389/fmicb.2016.00578. eCollection 2016.
PubMed 27199913Tamang JP, Watanabe K, Holzapfel WH. Review: Diversity of Microorganisms in Global Fermented Foods and Beverages. Front Microbiol. 2016 Mar 24;7:377. doi: 10.3389/fmicb.2016.00377. eCollection 2016.
PubMed 27047484Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.
PubMed 24912386Perna A, Intaglietta I, Simonetti A, Gambacorta E. Effect of genetic type and casein haplotype on antioxidant activity of yogurts during storage. J Dairy Sci. 2013 Jun;96(6):3435-41. doi: 10.3168/jds.2012-5859. Epub 2013 Mar 30.
PubMed 23548278Merenstein D, Murphy M, Fokar A, Hernandez RK, Park H, Nsouli H, Sanders ME, Davis BA, Niborski V, Tondu F, Shara NM. Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK study. A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial. Eur J Clin Nutr. 2010 Jul;64(7):669-77. doi: 10.1038/ejcn.2010.65. Epub 2010 May 19.
PubMed 20485304Brunser O, Araya M, Espinoza J, Guesry PR, Secretin MC, Pacheco I. Effect of an acidified milk on diarrhoea and the carrier state in infants of low socio-economic stratum. Acta Paediatr Scand. 1989 Mar;78(2):259-64. doi: 10.1111/j.1651-2227.1989.tb11066.x.
PubMed 2929349Campeotto F, Suau A, Kapel N, Magne F, Viallon V, Ferraris L, Waligora-Dupriet AJ, Soulaines P, Leroux B, Kalach N, Dupont C, Butel MJ. A fermented formula in pre-term infants: clinical tolerance, gut microbiota, down-regulation of faecal calprotectin and up-regulation of faecal secretory IgA. Br J Nutr. 2011 Jun 28;105(12):1843-51. doi: 10.1017/S0007114510005702. Epub 2011 Mar 22.
PubMed 21426607Nagata S, Asahara T, Ohta T, Yamada T, Kondo S, Bian L, Wang C, Yamashiro Y, Nomoto K. Effect of the continuous intake of probiotic-fermented milk containing Lactobacillus casei strain Shirota on fever in a mass outbreak of norovirus gastroenteritis and the faecal microflora in a health service facility for the aged. Br J Nutr. 2011 Aug;106(4):549-56. doi: 10.1017/S000711451100064X. Epub 2011 Apr 27.
PubMed 21521545Nocerino 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 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Upper Respiratory Tract and Gastrointestinal Infectious Diseases in Children: a Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05484102
- Acronym / sponsor ID
- FERCT19 / FERCT19
- Keywords
- Lactobacillus paracasei CBA L74, fermented milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Collaborators
- Heinz Italia SpA
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 2 Aug 2022 (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 is a double-blind randomized placebo controlled clinical trial. 200 healthy children aged 12-48 months, attending day care or preschool for at least 5 days a week, regularly checked by the family pediatrician (FP) involved in the trial, were considered for the study and consecutively contacted during scheduled medical examinations at the FPs office. study plan is 3-month treatment period. The clinical evaluation will be carried out at enrollment, at 30, 60 and 90 days from the beginning of the treatment by the pediatrician. fecal and nasal mucus samples for immunological and microbiological analysis will be collected before the treatment and at 90 days (end of treatment).
Detailed description
Subjects were supplemented daily for 3 months with cow's skim milk fermented with L. paracasei CBA L74 (group A) or placebo (group B).Enrolled children will be randomly assigned, with the use of a computer-generated randomization list to receive either milk fermented with Lactobacillus paracasei CBA L74 or placebo once. Placebo and fermented milk had the same shape, the placebo's taste, dimension, indication, and appearance. At enrollment the family pediatricians consulted the clinical records of each child for previous diseases and pharmacological treatments. At the baseline, after obtaining informed consent from the parents/tutors of each child, the health status of all the study subjects was carefully assessed, and the presence of infectious diseases or other disease was ruled out by means of a complete physical examination, including vital signs (body temperature, pulse rate, respiration rate, blood pressure); neurological status; body growth status; nutritional status; hydration; skin evaluation; otoscopy; evaluation of oral cavity; respiratory/abdomen/lymphonode examination; and genital examination.
A diary will be given to the parents; on a daily basis, patients will monitor and record the frequency/severity of symptoms, episodes of respiratory and/or gastrointestinal infection and their duration and school absence on the diary.
Fecal Analysis: three fecal samples for microbiological and immunological analysis will be collected before treatment and at 90 days (end of treatment). Nasal mucus samples for immunological analysis will be collected before the treatment and at 90 days (end of the treatment).
The study was approved by the Ethics Committee of the Universities of Bari.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| lactobacillus paracasei CBA L74 | Experimental | Dietary Supplement: milk fermented with lactobacillus paracasei CBA L74100 enrolled children will receive milk fermented with lactobacillus paracasei CBA L74 daily for 3 months. |
| placebo | Placebo comparator | Dietary Supplement: placebo milk formula100 enrolled children will receive placebo milk formula containing maltodextrins daily for 3 months. |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children aged 12-48 months
- attending day care or preschool for at least 5 days a week
Key exclusion criteria (12 listed)
- age <12 months or >48 months
- concomitant chronic infections, chronic systemic diseases, chronic inflammatory bowel diseases, autoimmune diseases, immunodeficiency, malignancy, metabolic diseases
- chronic respiratory tract diseases including respiratory allergies and cystic fibrosis
- malformations of gastrointestinal or urinary or respiratory tract
- history of respiratory or gastrointestinal or urinary tract surgery
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 |
|---|---|---|
| milk fermented with lactobacillus paracasei CBA L74milk fermented with lactobacillus paracasei CBA L74 will be administered daily for 3 months to 100 children. Participants were supplied with the milk product in powder form, by Heinz Italia SpA, Segrate, Italy. The study products were provided in tins containing 400 g of powder, and the packaging was similar and the tins were stored at room temperature in a dry environment. The family pediatricians instructed parents about the daily amount of the assigned study product and the method of preparation. All subjects received 7 g/day of study products diluted in a maximum of 150 mL of cow's milk or water. After dilution, the look and the taste were the same for all of the study products. | Dietary supplement | lactobacillus paracasei CBA L74 |
| placebo milk formulaplacebo milk formula containing maltodextrins will be administered daily for 3 months to 100 children. The study products were provided in tins containing 400 g of powder, and the packaging was similar and the tins were stored at room temperature in a dry environment. The family pediatricians instructed parents about the daily amount of the assigned study product and the method of preparation. All subjects received 7 g/day of study products diluted in a maximum of 150 mL of cow's milk or water. After dilution, the look and the taste were the same for all of the study products. | Dietary supplement | placebo |
Primary outcome
preventive effect of cow's milk fermented with Lactobacillus paracasei CBA L74 on common infectious disease
Time frame: 3 months
the rate of children experiencing at least one episode of common infectious disease
5 secondary outcomes
Total number of common infectious disease
Time frame: 3 months
use of medications
Time frame: 3 months
emergency department medical examinations and hospitalizations
Time frame: 3 months
days of work lost by the parents
Time frame: 3 months
days of school lost by the children
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 19 Sep 2024.
- Results publication: PubMed 21873895Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18.
- Results publication: PubMed 27199913Tamang JP, Shin DH, Jung SJ, Chae SW. Functional Properties of Microorganisms in Fermented Foods. Front Microbiol. 2016 Apr 26;7:578. doi: 10.3389/fmicb.2016.00578. eCollection 2016.
- Results publication: PubMed 27047484Tamang JP, Watanabe K, Holzapfel WH. Review: Diversity of Microorganisms in Global Fermented Foods and Beverages. Front Microbiol. 2016 Mar 24;7:377. doi: 10.3389/fmicb.2016.00377. eCollection 2016.
- Results publication: PubMed 24912386Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.
- Results publication: PubMed 23548278Perna A, Intaglietta I, Simonetti A, Gambacorta E. Effect of genetic type and casein haplotype on antioxidant activity of yogurts during storage. J Dairy Sci. 2013 Jun;96(6):3435-41. doi: 10.3168/jds.2012-5859. Epub 2013 Mar 30.
- Results publication: PubMed 20485304Merenstein D, Murphy M, Fokar A, Hernandez RK, Park H, Nsouli H, Sanders ME, Davis BA, Niborski V, Tondu F, Shara NM. Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK study. A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial. Eur J Clin Nutr. 2010 Jul;64(7):669-77. doi: 10.1038/ejcn.2010.65. Epub 2010 May 19.
- Results publication: PubMed 2929349Brunser O, Araya M, Espinoza J, Guesry PR, Secretin MC, Pacheco I. Effect of an acidified milk on diarrhoea and the carrier state in infants of low socio-economic stratum. Acta Paediatr Scand. 1989 Mar;78(2):259-64. doi: 10.1111/j.1651-2227.1989.tb11066.x.
- Results publication: PubMed 21426607Campeotto F, Suau A, Kapel N, Magne F, Viallon V, Ferraris L, Waligora-Dupriet AJ, Soulaines P, Leroux B, Kalach N, Dupont C, Butel MJ. A fermented formula in pre-term infants: clinical tolerance, gut microbiota, down-regulation of faecal calprotectin and up-regulation of faecal secretory IgA. Br J Nutr. 2011 Jun 28;105(12):1843-51. doi: 10.1017/S0007114510005702. Epub 2011 Mar 22.
- Results publication: PubMed 21521545Nagata S, Asahara T, Ohta T, Yamada T, Kondo S, Bian L, Wang C, Yamashiro Y, Nomoto K. Effect of the continuous intake of probiotic-fermented milk containing Lactobacillus casei strain Shirota on fever in a mass outbreak of norovirus gastroenteritis and the faecal microflora in a health service facility for the aged. Br J Nutr. 2011 Aug;106(4):549-56. doi: 10.1017/S000711451100064X. Epub 2011 Apr 27.
- Results publication: 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.
- Individual participant dataSharing planned: No. The investigators were blinded to the treatment at all times (i.e., allocation, intervention, laboratory analysis and statistical analysis). The study subjects were allocated to two groups (group A or group B) according to a computer-generated randomization list. The pediatricians, parents, and the children were blinded to the allocated treatment. Subjects were supplemented daily for 3 months with cow's skim milk fermented with L. paracasei CBA L74 (group A) or placebo (group B).
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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.
ruggiero francavilla principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing milk fermented with lactobacillus paracasei CBA L74 in people with Upper Respiratory Tract Infections and Gastrointestinal Infection, run by University of Bari 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 12 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 Sep 2024. 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.
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?
preventive effect of cow's milk fermented with Lactobacillus paracasei CBA L74 on common infectious disease (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 NCT05484102, which also lists 10 linked publications.
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 Sep 2024.