The aim of this randomized, double-blind, placebo-controlled interventional study is to evaluate the efficacy of Galactol® in adult patients aged 18 to 70 years with celiac disease and functional abdominal bloating.
The main question the study aims to answer is:
Does Galactol® improve the overall well-being of patients with celiac disease and functional abdominal bloating? Researchers will compare a group taking Galactol® with a group taking a placebo to determine whether the treatment leads to an improvement in overall well-being and gastrointestinal symptoms.
Participants will: be randomly assigned to either the Galactol® group or the placebo group; take the assigned product for 30 days; complete questionnaires and assessment scales to evaluate overall well-being, gastrointestinal symptoms, quality of life, mental health, and adherence to a gluten-free diet; undergo 5 mL blood draws before and after treatment to measure IL-10 and TNF-α levels; attend an initial visit and a visit after 30 days of treatment, during which tolerability, compliance, and any adverse events will also be assessed.
Patients who have provided written informed consent
Age: 18-70 years
Patients with celiac disease and functional abdominal bloating
Women who are pregnant or breastfeeding
Patients intolerant to one or more components of Galactol®/placebo
Patients allergic to one or more components of Galactol®/placebo
Parallel
Galactol®
Dietary supplementA food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase.
Placebo
Other interventionThe composition of the placebo product will be qualitatively the same as that of the verum product, but without the active components under investigation
Primary endpoint
The primary endpoint is the quantitative change in the patient's overall well-being, assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, with higher scores indicating better well-being. The change in VAS score will be calculated as the difference between the post-treatment visit (T2) and the baseline visit (T1) (T2-T1) in both groups. The change in VAS score will be compared between the treatment group and the placebo group.
Abdominal pain
Abdominal pain will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates absence of the symptom and 10 indicates a very severe symptom. Higher scores indicate greater symptom severity. The absolute change between T1 and T2 will be analyzed. A reduction of ≥3 cm will be considered a clinically relevant improvement.
Abdominal bloating
Abdominal bloating will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates no abdominal bloating and 10 indicates very severe abdominal bloating. Higher scores indicate greater symptom severity. The absolute change between T1 and T2 will be analyzed. A reduction of ≥3 cm will be considered a clinically relevant improvement.
Satisfaction with stool consistency
Satisfaction with stool consistency will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates complete dissatisfaction with stool consistency and 10 indicates very high satisfaction. Higher scores indicate greater satisfaction with stool consistency. The absolute change between T1 and T2 will be analyzed. An increase in the score between T1 and T2 will indicate an improvement in satisfaction with stool consistency.
Postprandial fullness severity
The severity of postprandial fullness will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates no postprandial fullness and 10 indicates very severe postprandial fullness. Higher scores indicate greater symptom severity. The absolute change between T1 and T2 will be analyzed. A reduction of ≥3 cm will be considered a clinically relevant improvement.
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead sponsor
PharmExtracta S.p.A.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
