Digestive Enzyme Formulation Intervention in IBS Patients Who Previously Clinically Responded to Mediterranean LFD
In plain words A study of digestive enzymes in people 18 to 65, run by Attikon Hospital. It plans to enroll about 40 people at 2 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 65. Conditions: Irritable Bowel Syndrome.
- 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…
- Subjects randomized to the MED-LFD arm of the previous study who could not adhere to the dietary intervention.
The exclusion criteria are on the listing.
What it tests, as registered
digestive enzymes
Registered 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. The full summary is on the listing.
Where, as registered
No US site; Greece (2).