Lactose IntolerantNCT06773650
Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation for Lactose Intolerance
An observational study of Lactose Intolerant and Lactose Malabsorption, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Lactose intolerance (LI) is considered the clinical syndrome caused by lactose malabsorption (LM). It is possible to identify four causes of lactase deficiency defining four different types of LM: primary (genetic), secondary (acquired), congenital (alactasia), and developmental (in premature infants, so reversible). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lactose Intolerant, Lactose Malabsorption, Lactose Intolerance
- What is being tested?
- Completion of online survey
- How many people
- 385 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2025to Jan 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding Lactose Intolerance
Who may be able to join
- Subjects must be adults (≥18 years of age)
- Willingness to complete the online survey
Who cannot join
- Subjects <18 years of age
- Subjects not available to answer the online survey
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
European Institute of Oncology
Milan
Patrizia Gnagnarella, +390257489823, patrizia.gnagnarella@ieo.it
About this study
Official title: Lactose Intolerance: a Guide to Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation
Lactose intolerance (LI) is considered the clinical syndrome caused by lactose malabsorption (LM).
It is possible to identify four causes of lactase deficiency defining four different types of LM: primary (genetic), secondary (acquired), congenital (alactasia), and developmental (in premature infants, so reversible).
The aim of this protocol is to investigate through an anonymous online survey the knowledge of the Italian population on clinical, pathophysiological, diagnostic and therapeutic issues of lactose intolerance. Data collected will be divulgated through a publication for both people with IL and nutritionists, enriched with tables and flow charts, to improve the knowledge on lactose intolerance and to support people suffering from this condition. The results of this survey will guide subjects suspected of suffering from lactose intolerance towards a correct diagnosis and a better management.
- Being tested
- Completion of online survey
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of online surveyOther
The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding LI
| Study group | Role | What they receive |
|---|---|---|
| Patients completing online survey | The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding Lactose Intolerance Receives: Other: Completion of online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of knowledge of the Italian population on lactose intolerance
The aim of this protocol is to investigate through an anonymous online survey the knowledge of the Italian population on clinical, pathophysiological, diagnostic and therapeutic issues of lactose intolerance
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 posted14 Jan 2025
- Study start8 Jan 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactose IntolerantStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773650
- Sponsor's protocol ID
- UID 4675
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactose Intolerance: a Guide to Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation
- ClinicalTrials.gov ID
- NCT06773650
- Acronym / sponsor ID
- UID 4675
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Jan 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.
Lactose intolerance (LI) is considered the clinical syndrome caused by lactose malabsorption (LM).
It is possible to identify four causes of lactase deficiency defining four different types of LM: primary (genetic), secondary (acquired), congenital (alactasia), and developmental (in premature infants, so reversible).
The aim of this protocol is to investigate through an anonymous online survey the knowledge of the Italian population on clinical, pathophysiological, diagnostic and therapeutic issues of lactose intolerance. Data collected will be divulgated through a publication for both people with IL and nutritionists, enriched with tables and flow charts, to improve the knowledge on lactose intolerance and to support people suffering from this condition. The results of this survey will guide subjects suspected of suffering from lactose intolerance towards a correct diagnosis and a better management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients completing online survey | – | Other: Completion of online surveyThe online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding Lactose Intolerance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding Lactose Intolerance
Key inclusion criteria (2 listed)
- Subjects must be adults (≥18 years of age)
- Willingness to complete the online survey
Key exclusion criteria (2 listed)
- Subjects <18 years of age
- Subjects not available to answer the online survey
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 |
|---|---|---|
| Completion of online surveyThe online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding LI | Other | Patients completing online survey |
Primary outcome
Evaluation of knowledge of the Italian population on lactose intolerance
Time frame: 3 months
The aim of this protocol is to investigate through an anonymous online survey the knowledge of the Italian population on clinical, pathophysiological, diagnostic and therapeutic issues of lactose intolerance
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 14 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Lactose Intolerant
Recruiting
Milk for Diabetes Prevention
Lactose Intolerance, Lactose Intolerant
RecruitingPhase 3
Predictive Value of Hydrogen/Methane Lactose Breath Testing on the Therapeutic Effect of Lactose-free Diet in Moderate to Severe ROME IV IBS.
Irritable Bowel Syndrome, Lactose Intolerant
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?
An observational study of Lactose Intolerant and Lactose Malabsorption, run by European Institute of Oncology 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 2 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 14 Jan 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. 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?
Contact Patrizia Gnagnarella (+390257489823, patrizia.gnagnarella@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of knowledge of the Italian population on lactose intolerance (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 14 Jan 2025.