Clinical trial NCT02636413: Evaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance
Official title: Evaluation of the Impact of LacTEST on Diagnostic Thinking and on Patient Management, and of the Reproducibility (Test-Retest), for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lactose Intolerance
Lead sponsor: VenterPharma
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate both the impact of LacTEST on diagnostic thinking and on patient management, and its reproducibility (Test-Retest), for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance.


Eligibility criteria: Inclusion Criteria:

1. Adults of either sex, between 18 and 70 years old.
2. Capacity for understanding and giving the informed consent to participate in this study.
3. Patients with clinical suggestive of lactose intolerance, primary or secondary, who have not been diagnosed and that fulfil the requirements allowed by the gaxilose summary of product characteristics (SmPC).

Exclusion Criteria:

1. Pregnant women or breast-feeding women.
2. Unable or reticent to give the informed consent or to comply with the study requirements.
3. Patients with glomerular filtration rate (GFR) less than 90 ml/min/1.73m2.
4. Portal hypertension: ascites, cirrhosis.
5. Medical records of total gastrectomy and/or vagotomy.
6. Patients diagnosed with myxedema.
7. Patients with Diabetes Mellitus.
8. Patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study.
9. Patients who are drug abuse consumers.
10. Patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test.
11. Patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests.
12. Patients who have taken aspirin of indomethacin in the 48h preceding the performance of the Gaxilose test.

Primary outcomes:
measure: Visual Analogical Scale
timeFrame: Through study completion, up to 10 months.
Secondary outcomes:
measure: Physician's Questionnaire
timeFrame: Through study completion, up to 10 months.
measure: Intraclass Correlation Coefficient
timeFrame: Through study completion, up to 10 months.
measure: Number of participants with treatment-related adverse events as assessed by the most recent version of MedDRA thesaurus.
timeFrame: Through study completion, up to 10 months.
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Girona
country: Spain
facility: Hospital Universitario Doctor Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: Hospital Universitario Ramón y Cajal
name: Laura Crespo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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