Abdominal Bloating, Irritable Bowel Syndrome
Conditions
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTGalactol®
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.
BEHAVIORALHigh-FODMAP Exclusion Diet
Participants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) during the 14-day study period.
Sponsors
Liaquat University of Medical & Health Sciences
University of Urbino "Carlo Bo"
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-Prandial Abdominal Bloating Intensity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intestinal Symptoms | Baseline to Day 14 | 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). |
| Treatment Adherence and Tolerability | Day 14 | Treatment adherence assessed as percentage of prescribed tablets taken and tolerability evaluated using a 0-10 scale at the end of treatment. |
| Change in Frequency of Bowel Movements | Baseline to Day 14 | Average number of bowel movements per day during the evaluation period. |
| Episodes of Diarrhea | Baseline to Day 14 | Number of diarrhea episodes per day recorded during the study period. |
| Global Gastrointestinal Well-Being | Day 14 | Participant-reported perception of gastrointestinal well-being using the Global GI Well-Being Scale (improved, unchanged, or worsened symptoms). |
| Change in Stool Consistency | Baseline to Day 14 | Stool consistency assessed using the Bristol Stool Scale (types 1-7). |
Countries
Italy
Outcome results
None listed