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Completed

NCT Number: NCT02636413

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

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.

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Key information

Conditions

Lactose Intolerance Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults of either sex, between 18 and 70 years old.
  • Capacity for understanding and giving the informed consent to participate in this study.
  • 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

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

Treatment and study plan

gaxilose

Drug

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

Other names: LacTEST

Lactose

Dietary Supplement

After lactose administration, expired hydrogen measurement at pre-specified intervals.

Other names: Hydrogen Breath Test (HBT)

Primary outcomes

  1. Visual Analogical Scale

    Time frame: 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 outcomes

  1. Physician's Questionnaire

    Time frame: 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.

  2. Intraclass Correlation Coefficient

    Time frame: 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.

  3. Number of participants with treatment-related adverse events as assessed by the most recent version of MedDRA thesaurus.

    Time frame: Through study completion, up to 10 months.

    To assess the safety profile of both tests performed, by assessing the frecuency of treatment-related AEs.

Sponsors and collaborators

Lead sponsor

VenterPharma

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2015
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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