Gastroenteric TractIMMUNOSICK24NCT07050693
Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections.
A study testing Vitamin + Zinc + micronutrient mixture in people with Gastroenteric Tract and Respiratory Tract, run by University of Bari at 1 site in Italy.
Trial summary
Respiratory and gastrointestinal infections are frequent problems in children under 4 years of age, especially after the start of schooling. These conditions are facilitated by an incomplete maturation of the immune system and by the anatomical and functional structure 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
- Gastroenteric Tract, Respiratory Tract, Infections
- What is being tested?
- Vitamin + Zinc + micronutrient mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week
Who cannot join
- Age less than 12 months and more than 48 months;
- Concomitant presence of chronic diseases
- Congenital heart disease;
- Tuberculosis;
- Functional gastrointestinal disorders;
- Gastrointestinal or urinary surgery of the respiratory tract;
Show all 22Show fewer
- Autoimmune diseases;
- Immunodeficiencies;
- Chronic inflammatory bowel diseases;
- Celiac disease;
- Cystic fibrosis;
- Metabolic diseases;
- Lactose intolerance;
- Tumors;
- Chronic lung diseases and malformations of the gastrointestinal tract;
- Food allergies;
- Eosinophilic esophagitis;
- Other hypereosinophilic diseases of the gastrointestinal tract;
- Diarrhea at enrollment;
- Severe malnutrition (z score for weight/height less than 3SD);
- Taking antibiotics and/or pre/pro/symbiotics/immunostimulants within 2 weeks of starting the study;
- Breastfeeding in progress
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Pediatria Trambusti
Bari, Bari, 70100
Ruggiero Francavilla, Prof, 00390805592063, ruggiero.francavilla@uniba.it
About this study
Official title: Efficacy of A 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections in Schhol-attended Children: a Randomized, Double-blind, Placebo-controlled Trial.
Respiratory and gastrointestinal infections are frequent problems in children under 4 years of age, especially after the start of schooling. These conditions are facilitated by an incomplete maturation of the immune system and by the anatomical and functional structure of the respiratory and gastrointestinal tract still in development.
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, sometimes with conflicting results. Some scientific evidence has shown that the administration of Vitamin D, Zinc, Beta glucan, 2'-Fucosyllactose can stimulate the immune defenses and reduce the number and severity of infectious episodes. In particular, 2'-fucosyllactose is one of the oligosaccharides of breast milk. It has both a prebiotic and immunoregulatory action since it is able to prevent the adhesion of pathogens to epithelial surfaces and subsequent translocation.
Healthy school-going children aged between 12 and 48 months, who attend school at least 5 days a week, will be evaluated.
- Being tested
- Vitamin + Zinc + micronutrient mixture, Placebo
- Keywords
- food supplement, gastroenteric infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin + Zinc + micronutrient mixtureDietary supplement
Also called Experimental arm
a dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose.
PlaceboDietary supplement
Placebo is identical to intervention product
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 50 children will take the product under study based on Vitamin D, Zinc, Beta glucan, 2'Fucosyllactose Receives: Dietary Supplement: Vitamin + Zinc + micronutrient mixture |
| Placebo | Placebo comparator | 50 children will take a carbohydrate-based control product (maltodextrin) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
The primary aim of the study will be the percentage of children who will present at least one infectious episode (acute gastroenteritis, rhinitis, otitis, pharyngitis, laryngitis, tracheitis) diagnosed by the pediatrician during the 3-month study period.
Measured: The dietary supplement and placebo will be administered for three months from the date of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start17 Apr 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastroenteric TractStudies 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
- Randomized double bind with placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruggiero Francavilla, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050693
- Sponsor's protocol ID
- IMMUNOSICK24
- Acronym
- IMMUNOSICK24
- Status last verified
- Jun 2025
- First submitted
- 21 Mar 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siziba LP, Mank M, Stahl B, Kurz D, Gonsalves J, Blijenberg B, Rothenbacher D, Genuneit J. Associations of Human Milk Oligosaccharides With Otitis Media and Lower and Upper Respiratory Tract Infections up to 2 Years: The Ulm SPATZ Health Study. Front Nutr. 2021 Oct 25;8:761129. doi: 10.3389/fnut.2021.761129. eCollection 2021.
PubMed 34760912Etzold S, Bode L. Glycan-dependent viral infection in infants and the role of human milk oligosaccharides. Curr Opin Virol. 2014 Aug;7:101-7. doi: 10.1016/j.coviro.2014.06.005. Epub 2014 Jul 19.
PubMed 25047751Hatakka K, Savilahti E, Ponka A, Meurman JH, Poussa T, Nase L, Saxelin M, Korpela R. Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial. BMJ. 2001 Jun 2;322(7298):1327. doi: 10.1136/bmj.322.7298.1327.
PubMed 11387176
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of A 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections in Schhol-attended Children: a Randomized, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT07050693
- Acronym / sponsor ID
- IMMUNOSICK24 / IMMUNOSICK24
- Keywords
- food supplement, gastroenteric infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 3 Jul 2025 (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.
Respiratory and gastrointestinal infections are frequent problems in children under 4 years of age, especially after the start of schooling. These conditions are facilitated by an incomplete maturation of the immune system and by the anatomical and functional structure of the respiratory and gastrointestinal tract still in development.
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, sometimes with conflicting results. Some scientific evidence has shown that the administration of Vitamin D, Zinc, Beta glucan, 2'-Fucosyllactose can stimulate the immune defenses and reduce the number and severity of infectious episodes. In particular, 2'-fucosyllactose is one of the oligosaccharides of breast milk. It has both a prebiotic and immunoregulatory action since it is able to prevent the adhesion of pathogens to epithelial surfaces and subsequent translocation.
Healthy school-going children aged between 12 and 48 months, who attend school at least 5 days a week, will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized double bind with placebo
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Vitamin + Zinc + micronutrient mixture50 children will take the product under study based on Vitamin D, Zinc, Beta glucan, 2'Fucosyllactose |
| Placebo | Placebo comparator | Dietary Supplement: Placebo50 children will take a carbohydrate-based control product (maltodextrin) |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week
Key exclusion criteria (22 listed)
- Age less than 12 months and more than 48 months;
- Concomitant presence of chronic diseases
- Congenital heart disease;
- Tuberculosis;
- Functional gastrointestinal disorders;
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 |
|---|---|---|
| Vitamin + Zinc + micronutrient mixtureAlso: Experimental arma dietary supplement containing Vitamin D, Zinc, Beta glucan WELLMUNE WGP, 2'Fucosyllactose. | Dietary supplement | Experimental |
| PlaceboPlacebo is identical to intervention product | Dietary supplement | Placebo |
Primary outcome
Primary outcome
Time frame: The dietary supplement and placebo will be administered for three months from the date of enrollment.
The primary aim of the study will be the percentage of children who will present at least one infectious episode (acute gastroenteritis, rhinitis, otitis, pharyngitis, laryngitis, tracheitis) diagnosed by the pediatrician during the 3-month study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 34760912Siziba LP, Mank M, Stahl B, Kurz D, Gonsalves J, Blijenberg B, Rothenbacher D, Genuneit J. Associations of Human Milk Oligosaccharides With Otitis Media and Lower and Upper Respiratory Tract Infections up to 2 Years: The Ulm SPATZ Health Study. Front Nutr. 2021 Oct 25;8:761129. doi: 10.3389/fnut.2021.761129. eCollection 2021.
- Background: PubMed 25047751Etzold S, Bode L. Glycan-dependent viral infection in infants and the role of human milk oligosaccharides. Curr Opin Virol. 2014 Aug;7:101-7. doi: 10.1016/j.coviro.2014.06.005. Epub 2014 Jul 19.
- Results publication: PubMed 11387176Hatakka K, Savilahti E, Ponka A, Meurman JH, Poussa T, Nase L, Saxelin M, Korpela R. Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial. BMJ. 2001 Jun 2;322(7298):1327. doi: 10.1136/bmj.322.7298.1327.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin + Zinc + micronutrient mixture in people with Gastroenteric Tract and Respiratory Tract, 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 1 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: The dietary supplement and placebo will be administered for three months from the date of enrollment.). 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 NCT07050693, which also lists 3 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 9 Jul 2025.