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Irritable Bowel SyndromeNCT05780749

A 14-week Pilot Prospective Clinical Trial With BiOkuris Product in Patients With Irritable Bowel Syndrome

A study testing DDI-IBS-001 in people with Irritable Bowel Syndrome, run by Biokuris s.a. at 11 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Irritable Bowel Syndrome (IBS) is a common chronic gastrointestinal condition that affects approximately 10-20% of adults in Western countries. IBS is a disorder with chronic or recurrent colonic symptoms without a clear-cut etiology. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
DDI-IBS-001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
11 sitesBelgium
Study dates
23 Nov 2023to 2 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult females and males, aged 18-75 years,
  • Diagnosis of IBS at least 6 months prior to study entry,
  • Confirmed IBS according to Rome-IV criteria (as determined by investigator),
  • Patient having either constipation (IBS-C), diarrhoea (IBS-D) or alternance of constipation/diarrhoea (IBS-M),
  • Possession of a digital device (i.e., smartphone or tablet),
  • Patient who read, understood, and signed the informed consent form (ICF),
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  • Patient willing to adhere to the study visit schedule and capable to understand and comply with protocol requirements and product intake,
  • Male, or female patient of childbearing potential, who agrees to use acceptable birth control methods throughout the study period.
  • As assessed at the end of the run-in period, week 2 :
  • Patient with a baseline score for abdominal pain ≥ 2 and < 6 assessed on a 7-point Lickert scale
  • Patient with correct and complete reporting of the study questionnaires and scores during the run-in period (≥75% completion)

Who cannot join

  • Severe gastrointestinal pathologies other than IBS, including: ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowel resection, auto-immune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, Graves' disease), bariatric surgery, acute or chronic diarrhoea secondary to confirmed infectious gastroenteritis, or enteral or parenteral nutrition,
  • Metabolic disorders affecting intestinal transit function or nutrient absorption including uncontrolled diabetes and uncontrolled dysthyroidism,
  • Patients experiencing complications of abdominal radiotherapy,
  • Surgical operations to the mouth or gastrointestinal tract within 4 weeks prior to study entry, or planned during the study; appendectomy within 6 months prior to study entry,
  • Galactose intolerance ,
  • Use of opioids or narcotic analgesics within 6 weeks prior to week 0,
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  • Systemic antibiotic treatment in progress or prescribed less than 4 weeks prior to study entry,
  • Use of products marketed as or rich in prebiotics, probiotics, or symbiotics (e.g., kefir, probiotic yogurt, baker's yeast, etc.) less than 2 weeks prior to week 0,
  • Use of laxatives, antibloating agents, antidiarrheal medication, antispasmodics, anxiolytics, antidepressants, analgesics, and non-steroidals anti-inflammatory drugs if started less than 2 months prior to week 0 . These medications are authorized if consumed for longer than 2 months before week 0 and maintained at a stable dosage for the entire study duration,,
  • Diets including low-FODMAP, KETO/high-fat, gluten free/coeliac, paleo, weight loss, caloric restriction, low-carb, 5:2/whole day energy restriction, Atkins/high-protein, sugar-free, single-food, juicing/any day of juicing, any other restriction diet (e.g. very low calory), or vegan diets if started less than 2 months prior or stopped less than 1 month prior to week 0. These diets are authorized if followed for longer than 2 months before week 0 and maintained for the entire study duration,,
  • Excessive alcohol consumption (more than 10 units per week) and/or drug abuse,
  • Pregnancy and lactation, or plan to become pregnant during the study period,
  • Participation in other studies involving investigational or marketed products concomitantly or less than 3 months prior to study entry,
  • Known hypersensitivity to any of the ingredients or excipients of the investigational products,
  • Patient who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.
  • As assessed at the end of the run-in period, week 2 :
  • Use of opioids or narcotic analgesics during the run-in period (between week 0 and week 1),
  • Systemic antibiotic treatment in progress or prescribed during the run-in period (between week 0 and week 1),
  • Deviation from lifestyle and dietary recommendations to be followed during the study (between week 0 and week 1).

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Belgium11 sites

  • Centre Hospitalier EpiCURA

    Ath, 7800

  • AZ Sint-Jan

    Bruges, 8000

  • AZ Sint-Lucas

    Bruges, 8310

  • CUB Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Sint-Lucas

    Ghent, 9000

  • UZ Brussel

    Jette, 1090

  • UZ Leuven

    Leuven, 3000

  • CHU Liege

    Liège, 4000

  • Clinique CHC Mont-Legia

    Liège, 4000

  • Centre Hospitalier du Bois de l'Abbaye

    Seraing, 4100

Other trials in Belgium

About this study

Official title: A 14-week Pilot Prospective Clinical Trial With BiOkuris Product in Patients With Irritable Bowel Syndrome.

Irritable Bowel Syndrome (IBS) is a common chronic gastrointestinal condition that affects approximately 10-20% of adults in Western countries. IBS is a disorder with chronic or recurrent colonic symptoms without a clear-cut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION. Symptoms include cramping, abdominal pain, bloating, gas, and diarrhea or constipation, or both. Over 80% of individuals with IBS report food-related symptoms leading in the 70% of these patients to self-imposed food restrictions and/or modifications of their diet. These spontaneous unsupervised dietary modifications are associated with maladaptive eating patterns and unnecessary self-restricted diets, which could result in nutritional deficiencies.

BiOkuris product DDI-IBS-001 is a food multicomponents product based on BiOkuris proprietary chitin-glucan complex. The objectives of the VITABIOTIC study is to confirm the effectiveness of the DDI-IBS-001 product in improving global symptoms, abdominal pain, stool consistency, quality of life, anxiety and depression in IBS patients and to confirm the product's safety.

Being tested
DDI-IBS-001, DDDI-IBS-001 placebo
Keywords
IBS, chitin-glucan
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.

  • DDI-IBS-001Dietary supplement

    The product is a combination of chitin-glucan and other dietary complement components. The dosage of chitin-glucan is 1.5 g/day. The product is a powder for oral administration 1x/day.

  • DDDI-IBS-001 placeboOther

    The placebo product has the same composition in excipient, same form and same posology as DDI-IBS-001.

Study groups in NCT05780749
Study groupRoleWhat they receive
Active arm - DDI-IBS-001ExperimentalNot described
Receives: Dietary Supplement: DDI-IBS-001
Placebo armPlacebo comparatorNot described
Receives: Other: DDDI-IBS-001 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptoms global assessment of relief (SGA) responder rate

    The primary outcome is the subjective global assessment (SGA) of relief responder rate at Week 8. Patients with an SGA of relief score of 3 points or less each week will be considered weekly responders. Patients who respond weekly for at least 50% of assessments after 2 weeks of Biokuris food supplement administration until V3 will be considered overall responders.

    Measured: Week 10 (8 weeks after run-in period)

Secondary outcomes (7)

  1. Weekly SGA responder rate

    The SGA of relief weekly responder rate after 8 weeks of Biokuris food supplement administration. Patients with an SGA of relief score of 3 points or less each week will be considered weekly responders.

    Measured: weekly from week 2 to week 14

  2. Individual symptoms

    Weekly change from baseline in mean 7-point Likert scale for each of the symptoms: abdominal pain, abdominal bloating, flatulence, dyschezia, pain during evacuation. Patients will score the intensity of each symptom individually from 1 (none) to 7 (very severe). Incidence of responders.

    Measured: weekly from week 2 to week 14

  3. stool consistency

    Change in the weekly mean number of normal stool consistency, evaluated with the BSS. Stool consistency (BSS score) will be described for each week until V4. The change in the weekly average number of normal stool consistency will be calculated between week 2 (baseline), and each week of treatment

    Measured: weekly from week 2 to week 14

  4. number of evacuation per day

    Change in the weekly mean number of evacuations per day. The mean daily number of bowel movements will be calculated for each week until week 14. The change in the weekly average number of evacuations will be calculated between week 2 (baseline), and each week of treatment, until week 14. A stratification will be performed according to weekly mean numbers registered at week 2.

    Measured: weekly from week 2 to week 14

  5. IBS-QoL

    Absolute and relative change of IBS-QoL (Quality of Life) score. An analysis for each of the 8 domains of the validated questionnaire will be performed.

    Measured: Week 0, week 4, week 8, week 10, week 14

  6. Anxiety & Depression

    Monthly change from baseline in Hospitalization Anxiety and Depression Scale (HADS) score. It is divided into an anxiety subscale (HADS-A) and a depression subscale (HADS-D), both containing 7 intermingled items, and are scored separately. For both scales, scores of less than 7 indicate non-cases, and between 8-10 mild, 11-14 moderate and 15-21 severe symptomatology.

    Measured: Week 0, week 4, week 8, week 10, week 14

  7. Adverse events

    occurrence and severity of adverse events

    Measured: Week 0, week 2, week 4, week 8, week 10, week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2023
  2. Study start23 Nov 2023
  3. Primary completion2 Feb 2025
  4. Study completion2 Feb 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, randomized, double-blind, placebo controlled, multicenter, parallel group study. Patients will be recruited in multiple centers in Belgium. Patients will be treated for a total of 12 weeks. The study consists of a 2 weeks run-in period followed by a 8 weeks treatment period with DDI-IBS-001. At the end of the 8 weeks treatment, patients will be divided in responders and non-responders based on their global symptoms' relief score (patients will be considered responders with a weekly SGA score mean of 3 points or less for at least 50% of the 6 last weeks of treatment before week 10 \[week 4 to 10\]). Responder patients will be randomised in a 2:1 allocation ratio to receive either DDI-IBS-001 or placebo, for 4 additional weeks. Non-responder patients will continue the treatment with DDI-IBS-001 for additional 4 weeks. The study period will be followed by a follow-up period of 4 weeks during which patients will have free access to DDI-IBS-001.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05780749
Sponsor's protocol ID
BK-IBS-2301
Status last verified
Apr 2025
First submitted
9 Mar 2023
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DDI-IBS-001 in people with Irritable Bowel Syndrome, run by Biokuris s.a. at 11 sites in Belgium.

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 11 inclusion and 19 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: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Belgium. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptoms global assessment of relief (SGA) responder rate (time frame: Week 10 (8 weeks after run-in period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05780749.

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 2 May 2025.

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