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

Lactose Intolerance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636413
• Other study ID #: VPH-GXL-2013-01
• Secondary ID: 2015-001181-26
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2015
• Last updated: December 27, 2016
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: VenterPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lactose Intolerance

Intervention

Drug:
• gaxilose
After gaxilose administration, urine collection, cuantification (firstly from 0 to 4 hours, and total urine from 0 to 5 hours), and xilose cuantification afterwards.

Dietary Supplement:
• lactose
After lactose administration, expired hydrogen measurement at pre-specified intervals.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Hospital Universitario Doctor Josep Trueta	Girona
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
VenterPharma

Country where clinical trial is conducted

Spain, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogical Scale	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.	Through study completion, up to 10 months.
Secondary	Physician's Questionnaire	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.	Through study completion, up to 10 months.
Secondary	Intraclass Correlation Coefficient	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.	Through study completion, up to 10 months.
Secondary	Number of participants with treatment-related adverse events as assessed by the most recent version of MedDRA thesaurus.	To assess the safety profile of both tests performed, by assessing the frecuency of treatment-related AEs.	Through study completion, up to 10 months.

External Links

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