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Digestive Enzyme Formulation Intervention in IBS Patients Who Previously Clinically Responded to Mediterranean LFD

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 7, 2025 (before its estimated October 10, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study title shortened, about 1 wordv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06749613
Lead Sponsor Attikon Hospital
Conditions
(from sponsor)		 Irritable Bowel Syndrome
Related terms Irritable Bowel Syndrome
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov