GAXILOSE for Lactose intolerance

Inclusion criteria

• {"criterion_text":"- Either male of female children between 5 or 11 years of age."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Participants with symptoms of lactose intolerance"}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to Gaxilose (LacTEST 0,45g)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Participant has a known medical history of decreased renal function of any cause"}
• {"criterion_text":"- Participant has a known medical history of either clinical or systemic manifestation of portal hypertension (i.e., ascites, cirrhosis…)."}
• {"criterion_text":"- Participant has a known medical history of total gastrectomy and/or vagotomy."}
• {"criterion_text":"- Participant has a known medical history of myxoedema."}
• {"criterion_text":"- Participant has a known medical history of pentosuria and/or galactosaemia."}
• {"criterion_text":"- Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study."}
• {"criterion_text":"- Participant has a known history of substance abuse."}
• {"criterion_text":"- Participant has taken either acetylsalicylic acid or indomethacin in the 48 hours prior to study enrollment."}
• {"criterion_text":"- Participant has been previously diagnosed as hypolactasic."}
• {"criterion_text":"- Any condition or situation precluding or interfering with the compliance with the protocol."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Diagnostic performance measured as sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using the proposed cut-off point of 19.18 mg of xylose at 5 hours of urine accumulation compared with the definitive diagnosis according to routine clinical practice."}

Secondary endpoints

• {"endpoint_text":"- Diagnostic performance of different cut-off of Xylose to classify pediatric patients as hypolactasic or normolactasic.","definition_or_measurement_approach":"Assessment of diagnostic performance metrics (e.g. sensitivity/specificity) for alternative xylose cut-off points to classify pediatric patients as hypolactasic or normolactasic."}
• {"endpoint_text":"- Diagnostic performance of shortening urine collection to 4 h using the best cut-off for this test.","definition_or_measurement_approach":"Evaluation of diagnostic performance (using the best identified cut-off) when urine collection is shortened to 4 hours."}
• {"endpoint_text":"- Number and percentage of AEs and its relationship with LacTEST 0.45 g in this pediatric population.","definition_or_measurement_approach":"Counting and reporting the number and percentage of adverse events and assessing their relationship to LacTEST 0.45 g."}

Methods

• Site-based recruitment at participating pediatric departments in Spain (listed hospital sites).
• Use of recruitment materials/documents including hospital posters ('VPH-GXL-2025-2_LacTEST_Cartel Hospitales_v1') and recruitment arrangements documentation ('K_Recruitments Arrangements in cover letter', 'Carta presentacion cartel informativo al CEIm').

Spain

Latest Decision Or Authorization Date

12-01-2026

Number Of Sites

11

Number Of Participants

164

Primary sponsor

Full Name

Venter Pharma S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain