Irritable Bowel SyndromeNCT07465562
Galactol® Enzyme Supplement for Post-Prandial Abdominal Bloating in Irritable Bowel Syndrome
A study testing Galactol® and High-FODMAP Exclusion Diet in people with Irritable Bowel Syndrome and Abdominal Bloating, run by Liaquat University of Medical & Health Sciences at 2 sites in Italy.
Trial summary
This multicenter, randomized, controlled clinical trial aims to evaluate the efficacy and safety of a dietary supplement containing a combination of digestive enzymes (alpha-galactosidase, beta-galactosidase, and prolyl-endopeptidase) in reducing post-prandial abdominal bloating in adults diagnosed with irritable… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome, Abdominal Bloating
- What is being tested?
- Galactol® and High-FODMAP Exclusion Diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Mar 2026to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Diagnosis of irritable bowel syndrome (IBS) according to Rome IV criteria
- Presence of abdominal discomfort and bloating related to food ingestion
- Ability and willingness to provide written informed consent
Who cannot join
- Age under 18 years
- Antibiotic therapy within 30 days prior to enrollment
- Presence of organic gastrointestinal diseases
- History of digestive system resection
- Pregnancy or breastfeeding
- Drug use or alcohol abuse during the study period
- Inability or refusal to provide written informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Nutribol
Reggio Calabria, Calabria, 89124
Casa di cura Quisisana
Rome, Lazio, 00197
About this study
Official title: Efficacy of a Mix of Specific Enzymes and Peptidases in Reducing Food-Related Abdominal Bloating: A Multicenter, Randomized, Controlled Clinical Trial
This multicenter, randomized, controlled clinical trial aims to evaluate the efficacy and safety of a dietary supplement containing a combination of digestive enzymes (alpha-galactosidase, beta-galactosidase, and prolyl-endopeptidase) in reducing post-prandial abdominal bloating in adults diagnosed with irritable bowel syndrome (IBS).
Participants will be randomly assigned in a 1:1 ratio to receive either the enzyme supplement (Galactol®) in addition to a diet excluding foods high in FODMAPs, or the diet alone. The intervention will be administered for 14 days.
Read more
The primary objective is to assess the change in the intensity of post-prandial abdominal bloating measured using a visual analogue scale (VAS). Secondary outcomes include changes in intestinal symptoms, stool consistency, bowel movement frequency, episodes of diarrhea, global gastrointestinal well-being, and treatment tolerability.
The results of this study will provide evidence regarding the potential role of enzyme supplementation in reducing gastrointestinal symptoms associated with food-related fermentation in patients with IBS.
Read the detailed description
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder frequently associated with post-prandial abdominal bloating and other intestinal symptoms. Certain dietary components, particularly foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), can contribute to symptom development through increased intestinal fermentation and gas production.
Dietary strategies such as restriction of high-FODMAP foods are commonly used to manage IBS-related symptoms. However, maintaining strict dietary restrictions can be difficult in routine clinical practice. Enzyme supplementation that facilitates the digestion of specific carbohydrates and gluten-related peptides may represent an alternative or complementary strategy to reduce intestinal fermentation and associated symptoms.
Galactol® is a dietary supplement containing alpha-galactosidase, beta-galactosidase, and a prolyl-endopeptidase derived from Aspergillus niger. These enzymes are intended to promote the digestion of fermentable carbohydrates and gluten-related peptides that may contribute to gastrointestinal discomfort.
This study is designed as a prospective, multicenter, randomized, controlled clinical trial with two parallel groups. Adult participants diagnosed with IBS according to Rome IV criteria and experiencing food-related abdominal bloating will be enrolled.
Participants will be randomly assigned in a 1:1 ratio to receive either Galactol® supplementation in addition to a diet excluding foods high in FODMAPs, or the diet alone. The treatment period will last 14 days.
Clinical assessments will be conducted at baseline and at the end of treatment. Outcomes will include evaluation of abdominal bloating intensity using a visual analogue scale (VAS), assessment of additional gastrointestinal symptoms, stool consistency using the Bristol Stool Scale, frequency of bowel movements, episodes of diarrhea, global gastrointestinal well-being, and treatment safety and tolerability.
The study aims to determine whether enzyme supplementation may improve gastrointestinal symptoms related to food intake in patients with IBS.
- Conditions
- Irritable Bowel Syndrome, Abdominal Bloating
- Being tested
- Galactol®, High-FODMAP Exclusion Diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galactol®Dietary supplement
Also called Digestive enzyme supplement
Galactol® is a dietary supplement containing alpha-galactosidase, beta-galactosidase, and prolyl-endopeptidase derived from Aspergillus niger. The supplement is administered orally as two tablets at lunch and two tablets at dinner daily for 14 days.
High-FODMAP Exclusion DietBehavioural
Participants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) during the 14-day study period.
| Study group | Role | What they receive |
|---|---|---|
| Galactol® + High-FODMAP Exclusion Diet | Experimental | Participants receive Galactol® enzyme supplementation in addition to a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs). The supplement is administered as two tablets at lunch and two tablets at dinner daily for 14 days. Receives: Dietary Supplement: Galactol®; Behavioral: High-FODMAP Exclusion Diet |
| High-FODMAP Exclusion Diet Alone | Active comparator | Participants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) without receiving the enzyme supplement during the 14-day study period. Receives: Behavioral: High-FODMAP Exclusion Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Prandial Abdominal Bloating Intensity
Change in the intensity of post-prandial abdominal bloating measured using a 0-10 visual analogue scale (VAS), where 0 indicates no symptoms and 10 indicates the worst symptoms.
Measured: Baseline (Day 0) to Day 14
Secondary outcomes (6)
Change in Intestinal Symptoms
Change in the intensity of intestinal symptoms including flatulence, abdominal discomfort, abdominal pain, and bowel urgency assessed using a 0-10 visual analogue scale (VAS).
Measured: Baseline to Day 14
Change in Stool Consistency
Stool consistency assessed using the Bristol Stool Scale (types 1-7).
Measured: Baseline to Day 14
Change in Frequency of Bowel Movements
Average number of bowel movements per day during the evaluation period.
Measured: Baseline to Day 14
Episodes of Diarrhea
Number of diarrhea episodes per day recorded during the study period.
Measured: Baseline to Day 14
Global Gastrointestinal Well-Being
Participant-reported perception of gastrointestinal well-being using the Global GI Well-Being Scale (improved, unchanged, or worsened symptoms).
Measured: Day 14
Treatment Adherence and Tolerability
Treatment adherence assessed as percentage of prescribed tablets taken and tolerability evaluated using a 0-10 scale at the end of treatment.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start16 Mar 2026
- Primary completion3 Jun 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: (1) Galactol® enzyme supplementation plus a diet excluding foods high in FODMAPs, or (2) a diet excluding foods high in FODMAPs alone. The treatment duration is 14 days.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465562
- Sponsor's protocol ID
- 156_9gennaio2026_GALACTOL®
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mix of Specific Enzymes and Peptidases in Reducing Food-Related Abdominal Bloating: A Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07465562
- Acronym / sponsor ID
- 156_9gennaio2026_GALACTOL®
- Conditions
- Irritable Bowel Syndrome, Abdominal Bloating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, controlled clinical trial aims to evaluate the efficacy and safety of a dietary supplement containing a combination of digestive enzymes (alpha-galactosidase, beta-galactosidase, and prolyl-endopeptidase) in reducing post-prandial abdominal bloating in adults diagnosed with irritable bowel syndrome (IBS).
Participants will be randomly assigned in a 1:1 ratio to receive either the enzyme supplement (Galactol®) in addition to a diet excluding foods high in FODMAPs, or the diet alone. The intervention will be administered for 14 days.
The primary objective is to assess the change in the intensity of post-prandial abdominal bloating measured using a visual analogue scale (VAS). Secondary outcomes include changes in intestinal symptoms, stool consistency, bowel movement frequency, episodes of diarrhea, global gastrointestinal well-being, and treatment tolerability.
The results of this study will provide evidence regarding the potential role of enzyme supplementation in reducing gastrointestinal symptoms associated with food-related fermentation in patients with IBS.
Detailed description
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder frequently associated with post-prandial abdominal bloating and other intestinal symptoms. Certain dietary components, particularly foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), can contribute to symptom development through increased intestinal fermentation and gas production.
Dietary strategies such as restriction of high-FODMAP foods are commonly used to manage IBS-related symptoms. However, maintaining strict dietary restrictions can be difficult in routine clinical practice. Enzyme supplementation that facilitates the digestion of specific carbohydrates and gluten-related peptides may represent an alternative or complementary strategy to reduce intestinal fermentation and associated symptoms.
Galactol® is a dietary supplement containing alpha-galactosidase, beta-galactosidase, and a prolyl-endopeptidase derived from Aspergillus niger. These enzymes are intended to promote the digestion of fermentable carbohydrates and gluten-related peptides that may contribute to gastrointestinal discomfort.
This study is designed as a prospective, multicenter, randomized, controlled clinical trial with two parallel groups. Adult participants diagnosed with IBS according to Rome IV criteria and experiencing food-related abdominal bloating will be enrolled.
Participants will be randomly assigned in a 1:1 ratio to receive either Galactol® supplementation in addition to a diet excluding foods high in FODMAPs, or the diet alone. The treatment period will last 14 days.
Clinical assessments will be conducted at baseline and at the end of treatment. Outcomes will include evaluation of abdominal bloating intensity using a visual analogue scale (VAS), assessment of additional gastrointestinal symptoms, stool consistency using the Bristol Stool Scale, frequency of bowel movements, episodes of diarrhea, global gastrointestinal well-being, and treatment safety and tolerability.
The study aims to determine whether enzyme supplementation may improve gastrointestinal symptoms related to food intake in patients with IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: (1) Galactol® enzyme supplementation plus a diet excluding foods high in FODMAPs, or (2) a diet excluding foods high in FODMAPs alone. The treatment duration is 14 days.
| Arm | Type | Receives |
|---|---|---|
| Galactol® + High-FODMAP Exclusion Diet | Experimental | Dietary Supplement: Galactol®, Behavioral: High-FODMAP Exclusion DietParticipants receive Galactol® enzyme supplementation in addition to a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs). The supplement is administered as two tablets at lunch and two tablets at dinner daily for 14 days. |
| High-FODMAP Exclusion Diet Alone | Active comparator | Behavioral: High-FODMAP Exclusion DietParticipants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) without receiving the enzyme supplement during the 14-day study period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Diagnosis of irritable bowel syndrome (IBS) according to Rome IV criteria
- Presence of abdominal discomfort and bloating related to food ingestion
- Ability and willingness to provide written informed consent
Key exclusion criteria (7 listed)
- Age under 18 years
- Antibiotic therapy within 30 days prior to enrollment
- Presence of organic gastrointestinal diseases
- History of digestive system resection
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galactol®Also: Digestive enzyme supplementGalactol® is a dietary supplement containing alpha-galactosidase, beta-galactosidase, and prolyl-endopeptidase derived from Aspergillus niger. The supplement is administered orally as two tablets at lunch and two tablets at dinner daily for 14 days. | Dietary supplement | Galactol® + High-FODMAP Exclusion Diet |
| High-FODMAP Exclusion DietParticipants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) during the 14-day study period. | Behavioural | Galactol® + High-FODMAP Exclusion Diet, High-FODMAP Exclusion Diet Alone |
Primary outcome
Change in Post-Prandial Abdominal Bloating Intensity
Time frame: Baseline (Day 0) to Day 14
Change in the intensity of post-prandial abdominal bloating measured using a 0-10 visual analogue scale (VAS), where 0 indicates no symptoms and 10 indicates the worst symptoms.
6 secondary outcomes
Change in Intestinal Symptoms
Time frame: Baseline to Day 14
Change in Stool Consistency
Time frame: Baseline to Day 14
Change in Frequency of Bowel Movements
Time frame: Baseline to Day 14
Episodes of Diarrhea
Time frame: Baseline to Day 14
Global Gastrointestinal Well-Being
Time frame: Day 14
Treatment Adherence and Tolerability
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galactol® and High-FODMAP Exclusion Diet in people with Irritable Bowel Syndrome and Abdominal Bloating, run by Liaquat University of Medical & Health Sciences at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-Prandial Abdominal Bloating Intensity (time frame: Baseline (Day 0) to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.