Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation for Lactose Intolerance

January 9, 2025 updated by: European Institute of Oncology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding Lactose Intolerance

Description

Inclusion Criteria:

  • Subjects must be adults (≥18 years of age)
  • Willingness to complete the online survey

Exclusion Criteria:

  • Subjects <18 years of age
  • Subjects not available to answer the online survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients completing online survey
The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding Lactose Intolerance
Other: Completion of online survey
The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding LI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UID 4675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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