Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study On The Efficacy Of Galactol In Patients With Celiac Disease And Functional Abdominal Disorders
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Summary
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.
Official title: Randomized Double-Blind Interventional Study To Evaluate The Efficacy Of Galactol In Patients With Celiac Disease And Functional Abdominal Pain
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-09
Completion Date
2027-12
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Galactol®
A food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase.
Placebo
The composition of the placebo product will be qualitatively the same as that of the verum product, but without the active components under investigation