An interventional study of Galactol® and Placebo in Celiac Disease, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Treatment
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.
352 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 214 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 77 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Galactol group, receiving treatment with Galactol®
Dietary Supplement: Galactol®
Placebo group, receiving the placebo product
Other: Placebo
A food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase.
The 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.
Time frame: 30 days (T1 to T2)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 30 days (T1 to T2)
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
Of 82 non-industry interventional studies with no phase under Celiac Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 9 months is below that.
Counting every sponsor, half of 87 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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