Digestive enzyme treatment for IBS patients who responded to a low FODMAP diet
Digestive Enzyme Formulation Intervention in Irritable Bowel Syndrome Patients Who Previously Clinically Responded to Mediterranean Low FODMAP Diet: A Single-Arm Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Attikon Hospital Academic / other |
| Locations | 2 sites (Chaïdári, Athens and 1 other locations) |
| Trial ID | NCT06749613 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are IBS patients who previously responded to a MED-LFD diet but have experienced a recurrence of symptoms.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chaïdári, Athens and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.