Study to evaluate the comparative efficacy of LacTEST for the diagnosis of hypolactasia in children presenting symptoms of lactose intolerance.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Venter Pharma S.L.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

14 Jul 2025 → ongoing

Decision date (initial)

2025-06-19

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Efficacy

The primary objective is the confirmation of the cut-off point proposed in the Phase I study, 19.18 mg of xylose in 5 hours of urine accumulation, to explore whether this cut-off point can classify pediatric patients as hypolactasic or normolactasic when compared with the definitive diagnosis according to the routine clinical practice.

Secondary objectives 3

1. Exploration of different cut-off points of xylose to classify pediatric patients as hypolactasic or normolactasic.
2. The possibility of shortening urine collection to 4 h to smooth the test in this pediatric population and search for the cut-off point.
3. Safety and tolerability of LacTEST 0.45 g in this pediatric population.

Conditions and MedDRA coding

Lactose intolerance

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Either male of female children between 5 or 11 years of age.
2. Participant’s parent(s)/legal guardian(s) are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Participants with symptoms of lactose intolerance

Exclusion criteria 13

1. Participant’s parent(s)/legal guardian(s) are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
2. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to Gaxilose (LacTEST 0,45g).
3. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to any of the ingredients of the on-site meals.
4. Participant has a known medical history of decreased renal function of any cause
5. Participant has a known medical history of either clinical or systemic manifestation of portal hypertension (i.e., ascites, cirrhosis…).
6. Participant has a known medical history of total gastrectomy and/or vagotomy.
7. Participant has a known medical history of myxoedema.
8. Participant has a known medical history of pentosuria and/or galactosaemia.
9. Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.
10. Participant has a known history of substance abuse.
11. Participant has taken either acetylsalicylic acid or indomethacin in the 48 hours prior to study enrollment.
12. Participant has been previously diagnosed as hypolactasic.
13. Any condition or situation precluding or interfering with the compliance with the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Diagnostic performance (sensitivity, specificity, PPV and NPV) of LacTEST 0.45 g in this pediatric population using the proposed cut-off point of 19.18 mg at 5 hours of urine accumulated.

Secondary endpoints 3

1. Diagnostic performance of different cut-off of Xylose to classify pediatric patients as hypolactasic or normolactasic.
2. Diagnostic performance of shortening urine collection to 4 h using the best cut-off for this test.
3. Number and percentage of AEs and its relationship with LacTEST 0.45 g in this pediatric population.

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 · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 8 files

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

Application history

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