Actively Recruiting
Digestive Enzyme Formulation Intervention in IBS Patients Who Previously Clinically Responded to Mediterranean LFD
Led by Attikon Hospital · Updated on 2025-01-07
40
Participants Needed
2
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Irritable bowel syndrome (IBS) is a highly prevalent chronic functional gastrointestinal disorder. The cardinal symptoms include abdominal pain, flatulence, bloating, and changes in bowel habits related to stool frequency and consistency, in the absence of detectable structural and biochemical abnormalities1,2. The prevalence is estimated at 5-10% among different ethnicities3. A low FODMAP diet is the most common dietary intervention with clinically proven benefits in symptom management and quality of life improvement of patients with Irritable Bowel Syndrome (IBS)4. Recently, a dietary digestive enzyme formulation (FODZYME©) claims similar efficacy in symptom management based on an ex-vivo study5. The study aims to examine the clinical efficacy of this formulation in managing IBS symptoms in patients who have previously clinically responded to a low FODMAP diet.
CONDITIONS
Official Title
Digestive Enzyme Formulation Intervention in IBS Patients Who Previously Clinically Responded to Mediterranean LFD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be available throughout the study period
- Have IBS diagnosed by Rome IV criteria (IBS-D, IBS-M, IBS-U) and previously responded to Mediterranean Low FODMAP diet with symptom recurrence (IBS-SSS > 175) after one year
- Include patients from previous study randomized to Mediterranean Low FODMAP diet who could not adhere to the diet
You will not qualify if you...
- Did not participate in the previous Mediterranean Low FODMAP diet study
- Were randomized to the NICE group in the previous study
- Have IBS-SSS score less than or equal to 175
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Attikon University General Hospital
Chaïdári, Athens, Greece
Actively Recruiting
2
Attikon University General Hospital
Athens, Greece, 12462
Actively Recruiting
Research Team
A
AREZINA KASTI, PhDc
CONTACT
K
Konstantinos Triantafyllou, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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