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

NCT02636413 | Completed Phase 4

• 2 other identifiers: VPH-GXL-2013-012015-001181-26
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 6

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.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Physician's Questionnaire

  Through study completion, up to 10 months.

• Intraclass Correlation Coefficient

  Through study completion, up to 10 months.

• 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.

Study Arms (2)

LacTEST

EXPERIMENTAL

0,45 g of gaxilose po, once, per diagnostic test performed.

Drug: gaxilose

Hydrogen Breath Test

ACTIVE COMPARATOR

25 to 50 g of lactose po, once, per diagnostic test performed.

Dietary Supplement: lactose

Interventions

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.

Also known as: LacTEST

LacTEST

lactose DIETARY_SUPPLEMENT

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

Also known as: Hydrogen Breath Test (HBT)

Hydrogen Breath Test

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• VenterPharma: lead

Study Sites (6)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Doctor Josep Trueta

Girona, Girona, 17007, Spain

Location

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

Location

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MeSH Terms

Conditions

Lactose Intolerance

Interventions

4-O-galactopyranosylxylose; Lactose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Laura Crespo, MD, PhD

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 21, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)