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Not yet recruitingPhase 4

Lactase activity test and gut barrier damage in adults with celiac disease

Tests whether a lactase activity measure reflects gut lining damage in celiac disease.

Key facts

Who runs it
Venter Pharma S.L.
Where
Spain1 site in 1 countryChoose a country to see its sites
Registry title
Clinical trial in people with celiac disease to analyze whether intestinal lactase activity is related to alterations in the intestinal barrier.
Status
Not yet recruiting
Phase
Phase 4
People taking part
42 people, planned
Started
4 May 2026
Expected to end
4 May 2027
Type of study
Interventional
Record updated
15 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who may have celiac disease. It tests whether LacTEST 0.45 g can show gut lining damage and leaky gut, and track recovery.

Age
18 to 70 years
Sex
All sexes
Disease stage
Suspected celiac disease, with symptoms that fit the disease.
Earlier treatment
People who take immunosuppressants (drugs that dampen the immune system) during the study cannot join.
Biomarker or test result
Positive anti-TG antibodies and HLA DQ2 and/or DQ8 haplotypes.

Main reasons for not taking part

  • Pregnancy or breastfeeding
  • Liver cirrhosis, other chronic liver or gut disease, or gut surgery (except removal of the appendix or gallbladder)
  • Moderate or severe kidney failure
  • Blood thinners or antiplatelet drugs that cannot be stopped 3-5 days before the gut biopsy, or other reasons endoscopy cannot be done
  • Past cancer, active inflammatory, bleeding, autoimmune or infectious gut disease, or Parkinson's disease, dementia or other neurodegenerative disease

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Adults aged between 18 and 70 years with suspected celiac disease due to compatible clinical symptoms and positive anti-TG antibodies and different HLA DQ2 and/or DQ8 haplotypes
  • Ability to understand the nature of the study and sign the informed consent form

Who cannot take part

  • History of anticoagulant/antiplatelet treatment that cannot be withdrawn in the days prior to the endoscopy
  • Known contraindication for endoscopy with multiple biopsies. Patients undergoing treatment with oral antiplatelet agents or anticoagulants who cannot discontinue such treatment 3-5 days prior to the intestinal biopsy
  • Liver cirrhosis or other chronic organic liver or digestive diseases, including digestive surgery, excluding appendectomy and cholecystectomy., since can affect permeability
  • Moderate or severe renal failure since can affect permeability
  • Portal hypertension (ascites, cirrhosis)
  • History of pentosuria and/or galactosemia
  • Hypersensitivity to the active ingredient Gaxilose
  • History of neoplasia or active inflammatory, hemorrhagic, autoimmune, and infectious intestinal diseases. Any other untreated chronic disease that may cause diarrhea or malabsorption
  • Severe and chronic mental illnesses, including psychosis
  • Parkinson's disease, dementia, and other neurodegenerative diseases, since can affect permeability
  • Pregnancy or breastfeeding
  • Total gastrectomy and/or vagotomy
  • Taking immunosuppressants during the study since affect permeability
  • Patients diagnosed with myxedema

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

To determine whether LacTEST 0.45 g can be used as a marker of the histological integrity of the intestinal mucosa and alterations in intestinal permeability in pathologies involving damage to the intestinal mucosa, such as CD, and to monitor recovery.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Clinical trial to evaluate the correlation between variation in intestinal lactase activity measured with LacTEST 0.45g and alteration of intestinal barrier integrity and/or intestinal permeability in patients with celiac disease
Plain-language title
Lactase activity test and gut barrier damage in adults with celiac diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
15 September 2026