Digestive enzyme treatment for IBS patients who 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
Run by Attikon Hospital · NCT06749613 · Data updated 2026-11-12
This study is testing if a digestive enzyme can help people with IBS who felt better on a low FODMAP diet but have had their symptoms come back after a year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Attikon Hospital Academic / other |
| Locations | 2 sites (Chaïdári, Athens and 1 other locations) |
| Status | Recruiting |
| Started | December 10, 2024 |
| Main results expected | October 10, 2025 |
| Study ends | March 30, 2026 |
| Registry record updated | January 7, 2025 |
| Trial ID | NCT06749613 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are IBS patients who previously responded to a MED-LFD diet but have experienced a recurrence of symptoms.
✕Probably not a fit
Patients who did not participate in the previous study or have mild symptoms (IBS-SSS < 175) may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of a digestive enzyme formulation in managing symptoms of Irritable Bowel Syndrome (IBS) in patients who previously benefited from a Mediterranean Diet Adjusted Low FODMAP (MED-LFD) diet. Eligible participants are those whose symptoms recurred after a year of initial dietary response. Each participant will receive a powdered digestive enzyme formulation to use over one month, with compliance monitored through jar weight and meal frequency assessments. The study aims to provide insights into the potential of digestive enzymes as a therapeutic option for IBS symptom management.
Why it matters
Potential benefit: If successful, this intervention could offer a new treatment option for IBS patients who struggle with recurring symptoms after dietary changes.
How similar studies have gone: While the use of digestive enzymes in IBS management is a novel approach, previous studies have shown dietary interventions like the low FODMAP diet to be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
-
Attikon University General Hospital
Chaïdári, Athens, Greece Recruiting -
Attikon University General Hospital
Athens, Greece Recruiting
Study contacts
- Study coordinator: AREZINA KASTI, PhDc
- Email: kastiare@yahoo.gr
- Phone: 6942917860
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.