Evaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance

Phase 4

Completed

• Conditions: Lactose Intolerance
• Interventions: Drug: gaxilose; Dietary Supplement: lactose

• Registration Number: NCT02636413
• Lead Sponsor: VenterPharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-21
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-27
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LacTEST	gaxilose	0,45 g of gaxilose po, once, per diagnostic test performed.
Hydrogen Breath Test	lactose	25 to 50 g of lactose po, once, per diagnostic test performed.

Primary Outcome Measures

Name	Time	Method
Visual Analogical Scale	Through study completion, up to 10 months.	The primary objective is to demonstrate non-inferiority of gaxilose test, compared with Hydrogen Breath Test (HBT) using a validated method (VAS results pre and post-test), on the impact on diagnostic thinking for the diagnosis of hypolactasia.

Secondary Outcome Measures

Name	Time	Method
Physician's Questionnaire	Through study completion, up to 10 months.	To demonstrate non-inferiority of gaxilose test, compared with Hydrogen Breath Test (HBT), on the impact on patient management for the diagnosis of hypolactasia, through a Physician's Qestionnaire.
Number of participants with treatment-related adverse events as assessed by the most recent version of MedDRA thesaurus.	Through study completion, up to 10 months.	To assess the safety profile of both tests performed, by assessing the frecuency of treatment-related AEs.
Intraclass Correlation Coefficient	Through study completion, up to 10 months.	To demonstrate gaxilose test reproducibility \[ICC (2,1)\] with urine accumulated from 0-4h after gaxilose administration, and with urine accumulated from 0-5h after gaxilose administration.

Trial Locations

Locations (6)

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Doctor Josep Trueta; 🇪🇸 Girona, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain