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Clinical trial in people with celiac disease to analyze whether intestinal lactase activity is related to alterations in the intestinal barrier.
EU CTIS ID: 2026-525518-70-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Pregnancy or breastfeeding.
- Patients diagnosed with myxedema.
- History of pentosuria and/or galactosemia.
- Hypersensitivity to the active ingredient Gaxilose.
- History of anticoagulant/antiplatelet treatment that cannot be withdrawn in the days prior to the endoscopy.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.
See the full eligibility criteria
- 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.
- Pregnancy or breastfeeding.
- Patients diagnosed with myxedema.
- History of pentosuria and/or galactosemia.
- Hypersensitivity to the active ingredient Gaxilose.
- History of anticoagulant/antiplatelet treatment that cannot be withdrawn in the days prior to the endoscopy.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.
- 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.
- Liver cirrhosis or other chronic organic liver or digestive diseases, including digestive surgery, excluding appendectomy and cholecystectomy.
- Moderate or severe renal failure
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.