Clinical trial in people with celiac disease to analyze whether intestinal lactase activity is related to alterations in the intestinal barrier.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Venter Pharma S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-06-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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.

Secondary objectives 7

1. To determine the correlation between the variation in intestinal lactase activity assessed by direct measurement of its activity at the tissue level and quantified by the xylose in urine excreted 5 hours after taking LacTEST 0.45g at baseline and 12 months after starting the GFD.
2. To determine the correlation between the variation in intestinal lactase activity assessed by direct measurement of its activity at the tissue level and quantified by the of xylose in urine excreted 5 hours after taking LacTEST 0.45g with intestinal permeability, determined by lactulose/mannitol (L/M) tests, evaluating lipopolysaccharide-binding protein (LBP) and lipopolysaccharide (LPS) co-receptor sCD14 and quantifying zonulin in stool, both at baseline and at 6 and 12 months after starting the GFD.
3. To determine the correlation between histological changes in the intestinal mucosa, evaluated according to the Marsh-Oberhuber classification, and changes in permeability with L/M, LBP, sCD14, and zonulin tests, both at baseline and 12 months after starting the GFD.
4. To determine the influence of dietary compliance on the evolution of intestinal atrophy, intestinal lactase activity, changes in permeability (L/M, LBP, sCD14, and zonulin), and symptoms by determining GIPs (gluten immunogenic peptides) in stool at baseline and at 6 and 12 months after starting the GFD.
5. Correlate all the analytical parameters studied with the symptoms at each point.
6. Study of the lymphogram to quantify the presence of a T lymphocyte subpopulation by quantifying the expression of the gamma delta TCR receptor in fresh tissue, with the aim of detecting subpopulations related to epithelial recovery, both at baseline and 12 months after the start of the DSG, and their correlation with the analytical parameters studied
7. Study of polymorphisms associated with the persistent lactase gene and their correlation with the analytical parameters studied.

Conditions and MedDRA coding

Patients with celiac disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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.
2. Ability to understand the nature of the study and sign the informed consent form.

Exclusion criteria 11

1. Pregnancy or breastfeeding.
2. Hypersensitivity to the active ingredient Gaxilose.
3. History of anticoagulant/antiplatelet treatment that cannot be withdrawn in the days prior to the endoscopy.
4. 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.
5. History of neoplasia or active inflammatory, hemorrhagic, autoimmune, and infectious intestinal diseases. Any other untreated chronic disease that may cause diarrhea or malabsorption.
6. Severe and chronic mental illnesses, including psychosis.
7. Parkinson's disease, dementia, and other neurodegenerative diseases.
8. Liver cirrhosis or other chronic organic liver or digestive diseases, including digestive surgery, excluding appendectomy and cholecystectomy.
9. Moderate or severe renal failure
10. Patients diagnosed with myxedema.
11. History of pentosuria and/or galactosemia.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Change in Marsh-Oberhuber classification (see section 6.2.4) after 12 months after starting the GFD treatment
2. Change in intestinal lactase activity (umol dissacharide/min/g tissue) assessed by direct measurement after 12 months after starting the GFD treatment.
3. Change in Xylose excreted (mg) in urine 5 hours after taking LacTEST 0.45g after 12 months after starting the GFD treatment

Secondary endpoints 28

1. Change in intestinal lactase activity (umol dissacharide/min/g tissue or U/g) assessed by direct measurement after 12 months after starting the GFD treatment
2. Change in Xylose excreted (mg) in urine 5 hours after taking LacTEST 0.45g after 6 and 12 months after starting the GFD treatment
3. Change in antitransglutaminase antibodies (IU/l, mg/dl or g/l) assessed in blood after 6 and 12 months after starting the GFD treatment
4. Change in intestinal lactase activity (umol dissacharide/min/g tissue or U/g) assessed by direct measurement after 12 months after starting the GFD treatment
5. Change in Xylose excreted (mg) in urine 5 hours after taking LacTEST 0.45g after 6 and 12 months after starting the GFD treatment
6. Change in L/M tests (% recovery of L and M, and LMR) after 6 and 12 months after starting the GFD treatment
7. Change in LBP (µg/ml) after 6 and 12 months after starting the GFD treatment
8. Change in sCD14 (ng/ml) after 6 and 12 months after starting the GFD treatment
9. Change in zonulin (ng/l) in stool after 6 and 12 months after starting the GFD treatment
10. Change in Marsh-Oberhuber classification (see section 6.2.4) after 12 months after starting the GFD treatment
11. Change in L/M tests (% recovery of L and M, and LMR) after 12 months after starting the GFD treatment
12. Change in LBP (µg/ml) after 12 months after starting the GFD treatment
13. Change in sCD14 (ng/ml) after 12 months after starting the GFD treatment
14. Change in zonulin (ng/l) in stool after 12 months after starting the GFD treatment
15. Symptoms by determining GIPs (gluten immunogenic peptides) (µg/g) after 6 and 12 months after starting the GFD treatment
16. Change in Xylose excreted (mg) in urine 5 hours after taking LacTEST 0.45g after 6 and 12 months after starting the GFD treatment
17. Change in L/M tests (% recovery of L and M, and LMR) after 6 and 12 months after starting the GFD treatment
18. Change in LBP (µg/ml) after 6 and 12 months after starting the GFD treatment
19. Change in sCD14 (ng/ml) after 12 months after starting the GFD treatment
20. Change in zonulin (ng/l) in stool after 6 and 12 months after starting the GFD treatment
21. Clinical evaluation (score) as a result of several questionnaires at each point: Gastrointestinal Symptom Rating Scale (GSRS), Canadian Celiac Health Survey questionnaire, Celiac Disease Quality of Life (CD-QOL) questionnaire, Celiac Dietary Adherence Test (CDAT).
22. Results of all the analytical parameters studied at each point, as detailed in the objectives above.
23. Quantity of a T lymphocyte subpopulation γδT cells (% expression of gamma delta TCR receptor) in fresh tissue, both at baseline and 12 months after the start of the DSG.
24. Results of all the analytical parameters studied, as detailed in the objectives above, both at baseline and 12 months after the start of the DSG,
25. Presence of genotypes C/C, CT or T/T in polymorphism C/T_13910 of MCM6 gene (regulatory region of the LCT gene).
26. Presence of genotypes G/G, G/A or A/A in polymorphism G/A_22018 of MCM6 gene (regulatory region of the LCT gene).
27. Results of the rest of the analytical parameters studied, as mentioned in the previous objectives.
28. Exploratory endpoints: Change (pg/ml or fold change) of several inflammatory cytokines assessed in blood, after 6 and 12 months after starting the GFD treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Venter Pharma S.L.

Sponsor organisation

Venter Pharma S.L.

Address

Calle De Almagro 1 Bajo Dcha 1

City

Madrid

Postcode

28010

Country

Spain

Scientific contact point

Organisation

Venter Pharma S.L.

Contact name

Carmen Hermida

Public contact point

Organisation

Venter Pharma S.L.

Contact name

Carmen Hermida

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications