BridgeMD
Study to evaluate the comparative efficacy of LacTEST for the diagnosis of hypolactasia in children presenting symptoms of lactose intolerance.
EU CTIS ID: 2025-521294-13-00
What this study is testing
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.
- 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
- Either male of female children between 5 or 11 years of age.
- 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.
- Participants with symptoms of lactose intolerance
You likely can't join if
- 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.
- Participant has a known history of substance abuse.
- Participant has taken either acetylsalicylic acid or indomethacin in the 48 hours prior to study enrollment.
- Participant has been previously diagnosed as hypolactasic.
- Any condition or situation precluding or interfering with the compliance with the protocol.
- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to Gaxilose (LacTEST 0,45g).
See the full eligibility criteria
- Either male of female children between 5 or 11 years of age.
- 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.
- Participants with symptoms of lactose intolerance
- 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.
- Participant has a known history of substance abuse.
- Participant has taken either acetylsalicylic acid or indomethacin in the 48 hours prior to study enrollment.
- Participant has been previously diagnosed as hypolactasic.
- Any condition or situation precluding or interfering with the compliance with the protocol.
- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to Gaxilose (LacTEST 0,45g).
- 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.
- Participant has a known medical history of decreased renal function of any cause
- Participant has a known medical history of either clinical or systemic manifestation of portal hypertension (i.e., ascites, cirrhosis…).
- Participant has a known medical history of total gastrectomy and/or vagotomy.
- Participant has a known medical history of myxoedema.
- Participant has a known medical history of pentosuria and/or galactosaemia.
- Participant is currently enrolled or has enrolled in a clinical trial three months prior to inclusion in the current study.
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, 0-17 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.