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

NCT06749613 | Recruiting

• 1 other identifier: ΕΒΔ 185/04-03-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

low FODMAP Diet; MED-LFD; digestive enzymes

Outcome Measures

Primary Outcomes (1)

• Changes in IBS-SSS from baseline to follow-up

  Changes in IBS-SSS from baseline to follow-up in the group of patients that have responded to MED-LFD in the past. The IBS-SSS questionnaire consists of 5 specific questions6. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from a minimum score of 0 to a maximum score of 100, using a visual analog scale (VAS), with total scores ranging from 0 to 500.

  1 month

Secondary Outcomes (3)

• Changes in the Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS).

  1 month

• Changes in SF-12.

  1 month

• Changes in IBS-Qol.

  1 month

Study Arms (1)

digestive enzymes group

EXPERIMENTAL

Patients will be instructed to use a powder formulation according to manufacturer instructions and according to the meals that they consume per day, for 1 month. To reduce the placebo effect, patients will be misinformed that half will take a placebo formulation, randomly.

Dietary Supplement: digestive enzymes

Interventions

digestive enzymes DIETARY_SUPPLEMENT

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.

digestive enzymes group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (2)

Attikon University General Hospital

Chaïdári, Athens, Greece

RECRUITING

Attikon University General Hospital

Athens, 12462, Greece

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

AREZINA KASTI, PhDc

CONTACT

6942917860; kastiare@yahoo.gr

Konstantinos Triantafyllou, Professor

CONTACT

6977402690; ktriant@med.uoa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Dietitian

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 27, 2024
• Study Start: December 10, 2024
• Primary Completion: October 10, 2025
• Study Completion: March 30, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

GR (2)