Study On The Efficacy Of Galactol In Patients With Celiac Disease And Functional Abdominal Disorders

Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study ID
NCT07831408
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Galactol® — DIETARY_SUPPLEMENT
    A food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase.
  • Placebo — OTHER
    The composition of the placebo product will be qualitatively the same as that of the verum product, but without the active components under investigation

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Galactol Group
    Galactol group, receiving treatment with Galactol®
  • Placebo Comparator: Placebo group
    Placebo group, receiving the placebo product

Primary Outcome Measure

Primary endpoint [ Time Frame: 30 days (T1 to T2) ]

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