RecruitingNot ApplicableNCT06749613

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

Digestive Enzyme Formulation Intervention in Irritable Bowel Syndrome Patients Who Previously Clinically Responded to Mediterranean Low FODMAP Diet: A Single-Arm Clinical Trial

Sponsor

Attikon Hospital

Enrollment

40 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

Irritable Bowel Syndrome

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. 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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria3

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

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Interventions

DIETARY_SUPPLEMENTdigestive enzymes

A jar or single-dose sachets containing the digestive enzymes in the form of powder will be provided to each patient at the study entry. Patients will be instructed to use the powder formulation according to manufacturer instructions and according to the meals that they consume per day, for 1 month. Participants will be asked to return the jar or the single dose sachets with the remaining product to assess compliance either by weighting the jar or by counting the number of single-dose sachets returned. To reduce the placebo effect, patients will be misinformed that half will take a placebo formulation, randomly. Participants will be asked to return the jar or the single-dose sachets with the remaining product to assess compliance either by weighting the jar or by counting the number of single-dose sachets returned.