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

NCT05780749 | Completed

• 1 other identifier: BK-IBS-2301
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 11

Brief 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. 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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; chitin-glucan

Outcome Measures

Primary Outcomes (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.

  Week 10 (8 weeks after run-in period)

Secondary Outcomes (7)

• Weekly SGA responder rate

  weekly from week 2 to week 14

• Individual symptoms

  weekly from week 2 to week 14

• stool consistency

  weekly from week 2 to week 14

• number of evacuation per day

  weekly from week 2 to week 14

• IBS-QoL

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

Study Arms (2)

Active arm - DDI-IBS-001

EXPERIMENTAL

Dietary Supplement: DDI-IBS-001

Placebo arm

PLACEBO COMPARATOR

Other: DDDI-IBS-001 placebo

Interventions

DDI-IBS-001 DIETARY_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.

Active arm - DDI-IBS-001

DDDI-IBS-001 placebo OTHER

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

Placebo arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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)

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Biokuris s.a.: lead

Study Sites (11)

Centre Hospitalier EpiCURA

Ath, 7800, Belgium

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

AZ Sint-Lucas

Bruges, 8310, Belgium

Location

CUB Hôpital Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

AZ Sint-Lucas

Ghent, 9000, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU Liege

Liège, 4000, Belgium

Location

Clinique CHC Mont-Legia

Liège, 4000, Belgium

Location

Centre Hospitalier du Bois de l'Abbaye

Seraing, 4100, Belgium

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan Tack, Professor

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The stage 2 of this study is a double-blinded study. Neither patients, nor investigators, nor trial staff, nor the sponsor study team will be aware of treatment assignments prior to the database lock at the conclusion of the study. The study products are DDI-IBS-001 and its matching placebo. DDI-IBS-001 and placebo will be provided as sachets containing 1980mg of powder to be dissolved in a glass of water (about 250 ml) and taken orally, with the same composition except for the active ingredient.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 23, 2023
• Study Start: November 23, 2023
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (11)