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Lactose IntolerancePhase 4NCT02636413

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

A Phase 4 study testing gaxilose and lactose in people with Lactose Intolerance, run by VenterPharma at 6 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lactose Intolerance
What is being tested?
gaxilose and lactose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
6 sitesSpain
Study dates
Oct 2015to Oct 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Spain6 sites

  • Hospital Universitario de Getafe

    Getafe, Madrid, 28905

  • Hospital Universitario Doctor Josep Trueta

    Girona, Girona, 17007

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

Other trials in Spain

About this study

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

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.

Being tested
gaxilose, lactose
Medical subject headings
Lactose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gaxiloseDrug

    Also called LacTEST

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

  • lactoseDietary supplement

    Also called Hydrogen Breath Test (HBT)

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

Study groups in NCT02636413
Study groupRoleWhat they receive
LacTESTExperimental0,45 g of gaxilose po, once, per diagnostic test performed.
Receives: Drug: gaxilose
Hydrogen Breath TestActive comparator25 to 50 g of lactose po, once, per diagnostic test performed.
Receives: Dietary Supplement: lactose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, up to 10 months.

Secondary outcomes (3)

  1. 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.

    Measured: Through study completion, up to 10 months.

  2. 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.

    Measured: Through study completion, up to 10 months.

  3. 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.

    Measured: Through study completion, up to 10 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02636413
Sponsor's protocol ID
VPH-GXL-2013-01
Other IDs
2015-001181-26, 2015
Status last verified
Dec 2016
First submitted
10 Dec 2015
Last updated
28 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Aragon JJ, Hermida C, Martinez-Costa OH, Sanchez V, Martin I, Sanchez JJ, Codoceo R, Cano JM, Cano A, Crespo L, Torres Y, Garcia FJ, Fernandez-Mayoralas A, Solera J, Martinez P. Noninvasive diagnosis of hypolactasia with 4-Galactosylxylose (Gaxilose): a multicentre, open-label, phase IIB-III nonrandomized trial. J Clin Gastroenterol. 2014 Jan;48(1):29-36. doi: 10.1097/MCG.0b013e318297fb10.

    PubMed 23722657

  • Chinn S. Statistics in respiratory medicine. 2. Repeatability and method comparison. Thorax. 1991 Jun;46(6):454-6. doi: 10.1136/thx.46.6.454. No abstract available.

    PubMed 1858087

  • Landis JR, Koch GG. An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics. 1977 Jun;33(2):363-74. No abstract available.

    PubMed 884196

  • Sahi T. Genetics and epidemiology of adult-type hypolactasia. Scand J Gastroenterol Suppl. 1994;202:7-20. doi: 10.3109/00365529409091740.

    PubMed 8042019

  • Villako K, Maaroos H. Clinical picture of hypolactasia and lactose intolerance. Scand J Gastroenterol Suppl. 1994;202:36-54. doi: 10.3109/00365529409091743.

    PubMed 8042017

  • Suchy FJ, Brannon PM, Carpenter TO, Fernandez JR, Gilsanz V, Gould JB, Hall K, Hui SL, Lupton J, Mennella J, Miller NJ, Osganian SK, Sellmeyer DE, Wolf MA. NIH consensus development conference statement: Lactose intolerance and health. NIH Consens State Sci Statements. 2010 Feb 24;27(2):1-27.

    PubMed 20186234

  • Newcomer AD, McGill DB, Thomas PJ, Hofmann AF. Prospective comparison of indirect methods for detecting lactase deficiency. N Engl J Med. 1975 Dec 11;293(24):1232-6. doi: 10.1056/NEJM197512112932405.

    PubMed 1186802

  • Jellema P, Schellevis FG, van der Windt DA, Kneepkens CM, van der Horst HE. Lactose malabsorption and intolerance: a systematic review on the diagnostic value of gastrointestinal symptoms and self-reported milk intolerance. QJM. 2010 Aug;103(8):555-72. doi: 10.1093/qjmed/hcq082. Epub 2010 Jun 3.

    PubMed 20522486

  • Shaukat A, Levitt MD, Taylor BC, MacDonald R, Shamliyan TA, Kane RL, Wilt TJ. Systematic review: effective management strategies for lactose intolerance. Ann Intern Med. 2010 Jun 15;152(12):797-803. doi: 10.7326/0003-4819-152-12-201006150-00241. Epub 2010 Apr 19.

    PubMed 20404262

  • Newcomer AD, McGill DB. Distribution of disaccharidase activity in the small bowel of normal and lactase-deficient subjects. Gastroenterology. 1966 Oct;51(4):481-8. No abstract available.

    PubMed 5922947

  • Hovde O, Farup PG. A comparison of diagnostic tests for lactose malabsorption--which one is the best? BMC Gastroenterol. 2009 Oct 31;9:82. doi: 10.1186/1471-230X-9-82.

    PubMed 19878587

  • Arola H. Diagnosis of hypolactasia and lactose malabsorption. Scand J Gastroenterol Suppl. 1994;202:26-35. doi: 10.3109/00365529409091742.

    PubMed 8042016

  • Aragon JJ, Canada FJ, Fernandez-Mayoralas A, Lopez R, Martin-Lomas M, Villanueva D. A direct enzymatic synthesis of beta-D-galactopyranosyl-D-xylopyranosides and their use to evaluate rat intestinal lactase activity in vivo. Carbohydr Res. 1996 Sep 2;290(2):209-16. doi: 10.1016/0008-6215(96)00113-9.

    PubMed 8823908

  • Hermida C, Corrales G, Canada FJ, Aragon JJ, Fernandez-Mayoralas A. Optimizing the enzymatic synthesis of beta-D-galactopyranosyl-D-xyloses for their use in the evaluation of lactase activity in vivo. Bioorg Med Chem. 2007 Jul 15;15(14):4836-40. doi: 10.1016/j.bmc.2007.04.067. Epub 2007 May 6.

    PubMed 17512743

  • Hermida C, Guerra P, Martinez-Costa OH, Sanchez V, Sanchez JJ, Solera J, Fernandez-Mayoralas A, Codoceo R, Frias J, Aragon JJ. Phase I and phase IB clinical trials for the noninvasive evaluation of intestinal lactase with 4-galactosylxylose (gaxilose). J Clin Gastroenterol. 2013 Jul;47(6):501-8. doi: 10.1097/MCG.0b013e318272f507.

    PubMed 23328304

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing gaxilose and lactose in people with Lactose Intolerance, run by VenterPharma at 6 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogical Scale (time frame: Through study completion, up to 10 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02636413, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.

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