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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT06749613

Run by

Attikon Hospital

People needed

40

Starts

2024-12-10

Expected to finish

2026-03-30

Last updated by the study team

2025-01-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of written informed consent.
• Commitment to availability throughout the study period.
• Patients who fulfilled the Rome IV criteria for IBS (IBS-D, IBS-M, IBS-U) participated in the two-arm clinical trial (ClinicalTrials.gov ID: NCT03997708) as responders to the Mediterranean Diet Adjusted to Low FODMAP (MED-LFD) (if their symptoms recurred -with IBS-SSS > 175- one year after their initial response to the dietary intervention).
• Subjects randomized to the MED-LFD arm of the previous study who could not adhere to the dietary intervention.

You may not qualify if…

• Patients who did not take part in the aforementioned study
• Patients who were randomized in the NICE group
• Patients with IBS-SSS<175.

Where it is running

• Attikon University General Hospital — Chaïdári, Athens, Greece (enrolling)
• Attikon University General Hospital — Athens, Greece (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.