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Digestive Enzyme Formulation Intervention in IBS Patients Who Previously Clinically Responded to Mediterranean LFD
Sponsor: Attikon Hospital
Summary
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.
Official title: Digestive Enzyme Formulation Intervention in Irritable Bowel Syndrome Patients Who Previously Clinically Responded to Mediterranean Low FODMAP Diet: A Single-Arm Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-12-10
Completion Date
2026-03-30
Last Updated
2025-01-07
Healthy Volunteers
No
Conditions
Interventions
digestive enzymes
A jar or single-dose sachets containing the digestive enzymes in the form of powder will be provided to each patient at the study entry. Patients will be instructed to use the powder formulation according to manufacturer instructions and according to the meals that they consume per day, for 1 month. Participants will be asked to return the jar or the single dose sachets with the remaining product to assess compliance either by weighting the jar or by counting the number of single-dose sachets returned. To reduce the placebo effect, patients will be misinformed that half will take a placebo formulation, randomly. Participants will be asked to return the jar or the single-dose sachets with the remaining product to assess compliance either by weighting the jar or by counting the number of single-dose sachets returned.
Locations (2)
Attikon University General Hospital
Chaïdári, Athens, Greece
Attikon University General Hospital
Athens, Greece