Evaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance
NCT ID: NCT02636413
Last Updated: 2016-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1 participants
INTERVENTIONAL
2015-10-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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LacTEST
0,45 g of gaxilose po, once, per diagnostic test performed.
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.
Hydrogen Breath Test
25 to 50 g of lactose po, once, per diagnostic test performed.
lactose
After lactose administration, expired hydrogen measurement at pre-specified intervals.
Interventions
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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.
lactose
After lactose administration, expired hydrogen measurement at pre-specified intervals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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VenterPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Crespo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramón y Cajal
Locations
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Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Doctor Josep Trueta
Girona, Girona, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Countries
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References
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Other Identifiers
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2015-001181-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VPH-GXL-2013-01
Identifier Type: -
Identifier Source: org_study_id