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

Overview

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.

The study is designed as a non-pharmacological interventional clinical investigation aimed at evaluating the effect of a food supplement on overall well-being and gastrointestinal symptoms in adult subjects with celiac disease (CD) and functional abdominal bloating. The study design involves a comparison between the intake of Galactol® and a placebo, with treatment effects assessed using clinical tools and validated questionnaires, as well as through the measurement of specific blood biomarkers. The primary objective is to determine whether the intervention results in an improvement in patients' perceived overall well-being over a 30-day period compared with baseline, and whether any such improvement differs from that observed in subjects receiving the placebo. A total of 50 adult patients are expected to be enrolled. Participants will be randomly assigned to the treatments in a 1:1 ratio and will therefore be allocated to two groups of comparable size: intervention group, receiving treatment with Galactol®; placebo group, receiving the placebo product. The intervention group will receive Galactol®, a food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase. The treatment will be administered for 30 days as follows: 2 tablets at the beginning of lunch; 2 tablets at the beginning of dinner. The control group will receive a placebo with characteristics corresponding to those of the active product and with identical administration schedules and timing. The use of a placebo is intended, as far as possible, to distinguish the specific effect of the supplement from non-specific effects associated with participation in the study, the attention received from healthcare staff, and participants' expectations. Each participant will take part in three main study visits: a screening visit, a baseline visit and a visit at the end of the treatment period. Screening visit (T0): During this visit, the patient will be informed about the possibility of taking part in the study and will receive information about its purpose, procedures and duration. Participation will be voluntary and will require the participant to provide written informed consent. Only eligible participants will proceed to the baseline visit. Baseline visit (T1): The T1 visit will take place within 7 days of the screening visit. During this visit, information about the participant's health and general characteristics will be collected, including age, sex, body mass index, available blood test results and medical history. A nutritional assessment will also be performed, including a dietary history and anthropometric measurements. Particular attention will be paid to adherence to the gluten-free diet (GFD), as this may influence gastrointestinal symptoms and the results of the study. Before treatment begins, a small blood sample (5 mL) will be collected specifically for the study. The sample will be used to measure IL-10 and TNF-α levels. Overall well-being will be assessed using a visual analogue scale (VAS) from 0 to 10, allowing participants to indicate how satisfied they are with their overall well-being. Gastrointestinal symptoms will be assessed using VAS scales from 0 to 10, covering abdominal pain, stool consistency, abdominal bloating, post-meal fullness, early satiety and epigastric burning. Higher scores indicate more severe symptoms. Quality of life will be assessed using the SF-36 questionnaire, while mental health symptoms will be evaluated using the Symptom Checklist-90-R (SCL-90). Adherence to the gluten-free diet will be assessed using the CDAT questionnaire. End-of-treatment visit (T2): The T2 visit will take place after 30 days of treatment. The purpose of this visit is to assess any changes compared with the participant's baseline condition. The assessments of overall well-being, gastrointestinal symptoms, quality of life and mental health will therefore be repeated using the same questionnaires and scales used at T1. Adherence to the gluten-free diet will also be reassessed to determine whether it has remained stable throughout the treatment period. A second 5 mL blood sample will be collected to measure IL-10 and TNF-α levels. These results will be compared with the baseline measurements to assess any changes during the treatment period.