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

Randomized Double-Blind Interventional Study To Evaluate The Efficacy Of Galactol In Patients With Celiac Disease And Functional Abdominal Pain

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Celiac Disease
• Intervention / Treatment: Dietary supplement: Galactol®; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who have provided written informed consent
• Age: 18-70 years
• Patients with celiac disease and functional abdominal bloating

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Galactol Group; Galactol group, receiving treatment with Galactol®	Dietary supplement: 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 Comparator: Placebo group; Placebo group, receiving the placebo product	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days (T1 to T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days (T1 to T2)
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.	30 days (T1 to T2)
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.	30 days (T1 to T2)
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.	30 days (T1 to T2)
Severity of early satiety	The severity of early satiety will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates no early satiety and 10 indicates very severe early satiety. 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.	30 days (T1 to T2)
Gastric burning severity	The severity of gastric burning will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates no gastric burning and 10 indicates very severe gastric burning. 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.	30 days (T1 to T2)
Improvement in quality of life and mental health	Quality of life will be assessed before and after treatment using the 36-Item Short Form Health Survey (SF-36), with comparison of the scores obtained at T1 and T2. An increase in the score between T1 and T2 (T2-T1 > 0) will be interpreted as indicative of an improvement in perceived quality of life.	30 days (T1 to T2)
Improvement in quality of life and mental health	Psychological distress will be assessed before and after treatment using the Symptom Checklist-90 (SCL-90), with comparison of the scores obtained at T1 and T2. Since higher scores reflect a higher level of psychological distress, a reduction in the score between T1 and T2 (T2-T1 < 0) will be interpreted as indicative of an improvement.	30 days (from T1 to T2)
Intestinal permeability indicators	Quantification of the pre- and post-treatment changes in plasma concentrations of IL-10 (pg/mL) and TNF-α (pg/mL).	30 days (T1 to T2)

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Collaborators: PharmExtracta S.p.A.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 1, 2026
• First Submitted That Met QC Criteria: September 15, 2026
• First Posted (Actual): September 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 21, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Gluten-free diet; Food supplement; Celiac disease; Abdominal bloating; Functional abdominal bloating
• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Nutritional and Metabolic Diseases; Celiac Disease
• Other Study ID Numbers: ID6919

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No