Irritable Bowel SyndromeNCT06749613
Digestive Enzyme Formulation Intervention in IBS Patients Who Previously Clinically Responded to Mediterranean LFD
A study testing digestive enzymes in people with Irritable Bowel Syndrome, run by Attikon Hospital at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- digestive enzymes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesGreece
- Study dates
- 10 Dec 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who did not take part in the aforementioned study
- Patients who were randomized in the NICE group
- Patients with IBS-SSS<175.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
Attikon University General Hospital
Athens, 12462
Arezina Kasti, 2105832565 ext. +30, kastiare@yahoo.gr
- Recruiting
Attikon University General Hospital
Chaïdári, Athens
MAROULLA I NIKOLAKI, phD (c), 6979376752, mnikolaki@med.uoa.gr
arezina kasti, 6942917860, kastiare@yahoo.gr
About this study
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
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.
Read the detailed description
IBS patients who participated in a two-arm clinical trial (ClinicalTrials.gov ID: NCT03997708) and responded to the Mediterranean Diet Adjusted Low FODMAP (MED-LFD) Diet will be considered eligible if their symptoms recurred one year after their initial response to the dietary intervention. Among them, patients without any or mild symptoms, defined as IBS severity scoring system (IBS-SSS) ≤ 175, will be excluded. Moreover, subjects who were randomized to the MED-LFD arm in the previous study, but could not adhere to the dietary intervention, will be included too.
A jar containing the digestive enzymes in the form of powder will be provided to each patient at the start of the study. Patients will be instructed to use the powder formulation according to manufacturer instructions for 1 month. To assess compliance, the weight of each jar will be measured both at the initiation and the end of the study. Patients will also be asked on three different days (one day from the weekend), to estimate the average number of meals per day. Due to the limited sample size (54 patients who received the MED-LFD diet in the previous phase will be screened for eligibility), a control group will be omitted. To reduce the placebo effect, patients will be misinformed that half will take a placebo formulation, randomly.
All patients will be thoroughly trained regarding the proper consumption of the powder (exact dose, timing, etc.), through personal training, videos, leaflets, and other type of training materials.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- digestive enzymes
- Keywords
- low FODMAP Diet, MED-LFD, digestive enzymes
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digestive enzymesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: digestive enzymes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
Changes in the Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS).
The GSRS questionnaire is validated in patients with IBS. GSRS-IBS consists of 13 items, designed to assess gastrointestinal symptoms specifically for IBS patients. Each item is rated based on a 7-point Likert scale (1. "No discomfort at all"; 2. "Minor discomfort"; 3. "Mild discomfort"; 4. "Moderate discomfort"; 5. "Moderately severe discomfort"; 6. "Severe discomfort"; 7. "Very severe discomfort"). The questionnaire has a total score and five subscales (pain, bloating, constipation, diarrhea, and satiety), calculated by summing all questions corresponding to each scale and dividing with the number of questions summed in each scale. Both total and subscale scores are ranging from 1 (no discomfort) to 7 (severe discomfort), with higher scores representing increased symptom burden.
Measured: 1 month
Changes in SF-12.
SF-12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective, covering two domains of health outcomes: physical functioning and mental health. The items are weighted and summed to provide physical and mental health scores. The two composite scores are computed using the scores on the questions that range from 0 to 100, with higher score indicating better QoL. SF-12 is validated also in the Greek population.
Measured: 1 month
Changes in IBS-Qol.
The IBS-QoL assesses the degree to which IBS interfered with quality of life over the past 30 days10. It is a self-reported quality of life measure, which includes eight domains, such as dysphoria, interference with activity, body image, health worry, food avoidance, social relations, sexual and relationship issues. Each of them is rated based on a 5-point Likert scale (1. "Not at all"; 2." Slightly"; 3. "Moderately"; 4. "Quite a bit" 5. "Extremely/ A great deal").
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start10 Dec 2024
- Primary completion10 Oct 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arezina Kasti, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749613
- Sponsor's protocol ID
- ΕΒΔ 185/04-03-2024
- Status last verified
- Jan 2025
- First submitted
- 10 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06749613
- Acronym / sponsor ID
- ΕΒΔ 185/04-03-2024
- Conditions
- Irritable Bowel Syndrome
- Keywords
- low FODMAP Diet, MED-LFD, digestive enzymes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IBS patients who participated in a two-arm clinical trial (ClinicalTrials.gov ID: NCT03997708) and responded to the Mediterranean Diet Adjusted Low FODMAP (MED-LFD) Diet will be considered eligible if their symptoms recurred one year after their initial response to the dietary intervention. Among them, patients without any or mild symptoms, defined as IBS severity scoring system (IBS-SSS) ≤ 175, will be excluded. Moreover, subjects who were randomized to the MED-LFD arm in the previous study, but could not adhere to the dietary intervention, will be included too.
A jar containing the digestive enzymes in the form of powder will be provided to each patient at the start of the study. Patients will be instructed to use the powder formulation according to manufacturer instructions for 1 month. To assess compliance, the weight of each jar will be measured both at the initiation and the end of the study. Patients will also be asked on three different days (one day from the weekend), to estimate the average number of meals per day. Due to the limited sample size (54 patients who received the MED-LFD diet in the previous phase will be screened for eligibility), a control group will be omitted. To reduce the placebo effect, patients will be misinformed that half will take a placebo formulation, randomly.
All patients will be thoroughly trained regarding the proper consumption of the powder (exact dose, timing, etc.), through personal training, videos, leaflets, and other type of training materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| digestive enzymes group | Experimental | Dietary Supplement: digestive enzymesPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who did not take part in the aforementioned study
- Patients who were randomized in the NICE group
- Patients with IBS-SSS<175.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digestive enzymesA 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. | Dietary supplement | digestive enzymes group |
Primary outcome
Changes in IBS-SSS from baseline to follow-up
Time frame: 1 month
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.
3 secondary outcomes
Changes in the Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS).
Time frame: 1 month
Changes in SF-12.
Time frame: 1 month
Changes in IBS-Qol.
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digestive enzymes in people with Irritable Bowel Syndrome, run by Attikon Hospital at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AREZINA KASTI, PhDc (6942917860 ext. +30, kastiare@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in IBS-SSS from baseline to follow-up (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.