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

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: DDI-IBS-001; Other: DDDI-IBS-001 placebo

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salvatore Modica; Phone Number: +32 4 259 85 00; Email: s.modica@biokuris.com

Study Locations

• Belgium
  • Ath, Belgium, 7800
    • Recruiting
    • Centre Hospitalier EpiCURA
    • Contact: Sophie Viart
    • Principal Investigator: Sandra Mupingu, Dr.
  • Brugge, Belgium, 8310
    • Recruiting
    • AZ Sint-Lucas
    • Contact: Justine Luca
    • Principal Investigator: Joris Arts, Dr
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan
    • Contact: Fabienne DeVos; Email: fabienne.devos@azsintjan.be
    • Principal Investigator: Christophe Snauwaert, Dr
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Fabiola Umuhire
    • Principal Investigator: Hubert Snauwaert, Professor
  • Bruxelles, Belgium, 1070
    • Recruiting
    • CUB Hôpital Erasme
    • Contact: Pauline Vanhouytsel
    • Principal Investigator: Hubert Louis, Professor
  • Gent, Belgium, 9000
    • Recruiting
    • AZ Sint-Lucas
    • Contact: Sophie Claeys
    • Principal Investigator: Frederick de Clerck, Dr.
  • Jette, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Ileana Smets
    • Principal Investigator: Sébastien Kindt, Dr
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Liselot Holvoet; Email: liselot.holvoet@uzleuven.be
    • Principal Investigator: Jan Tack, Professor
  • Liege, Belgium, 4000
    • Recruiting
    • CHU Liege
    • Contact: Sylvie Wertz; Email: swertz@chuliege.be
    • Principal Investigator: Pascale Latour, Dr
  • Liege, Belgium, 4000
    • Recruiting
    • Clinique CHC Mont-Legia
    • Contact: Audrey Duyckaerts
    • Principal Investigator: Boris Bastens, Dr.
  • Seraing, Belgium, 4100
    • Recruiting
    • Centre Hospitalier du Bois de l'Abbaye
    • Contact: Violaine Bernard, Dr.
    • Principal Investigator: Violaine Bernard, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult females and males, aged 18-75 years,
2. Diagnosis of IBS at least 6 months prior to study entry,
3. Confirmed IBS according to Rome-IV criteria (as determined by investigator),
4. Patient having either constipation (IBS-C), diarrhoea (IBS-D) or alternance of constipation/diarrhoea (IBS-M),
5. Possession of a digital device (i.e., smartphone or tablet),
6. Patient who read, understood, and signed the informed consent form (ICF),
7. Patient willing to adhere to the study visit schedule and capable to understand and comply with protocol requirements and product intake,

8. 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 :

9. Patient with a baseline score for abdominal pain ≥ 2 and < 6 assessed on a 7-point Lickert scale
10. Patient with correct and complete reporting of the study questionnaires and scores during the run-in period (≥75% completion)

Exclusion Criteria:

1. 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,
2. Metabolic disorders affecting intestinal transit function or nutrient absorption including uncontrolled diabetes and uncontrolled dysthyroidism,
3. Patients experiencing complications of abdominal radiotherapy,
4. 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,
5. Galactose intolerance ,
6. Use of opioids or narcotic analgesics within 6 weeks prior to week 0,
7. Systemic antibiotic treatment in progress or prescribed less than 4 weeks prior to study entry,
8. 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,
9. 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,,
10. 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,,
11. Excessive alcohol consumption (more than 10 units per week) and/or drug abuse,
12. Pregnancy and lactation, or plan to become pregnant during the study period,
13. Participation in other studies involving investigational or marketed products concomitantly or less than 3 months prior to study entry,
14. Known hypersensitivity to any of the ingredients or excipients of the investigational products,

15. 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 :

16. Use of opioids or narcotic analgesics during the run-in period (between week 0 and week 1),
17. Systemic antibiotic treatment in progress or prescribed during the run-in period (between week 0 and week 1),
18. Deviation from lifestyle and dietary recommendations to be followed during the study (between week 0 and week 1).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo arm	Other: DDDI-IBS-001 placebo; The placebo product has the same composition in excipient, same form and same posology as DDI-IBS-001.
Experimental: Active arm - DDI-IBS-001	Dietary supplement: DDI-IBS-001; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	weekly from week 2 to week 14
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.	Week 0, week 4, week 8, week 10, week 14
Adverse events	occurrence and severity of adverse events	Week 0, week 2, week 4, week 8, week 10, week 14
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.	weekly from week 2 to week 14
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	weekly from week 2 to week 14
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.	weekly from week 2 to week 14
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.	Week 0, week 4, week 8, week 10, week 14

Collaborators and Investigators

• Sponsor: Biokuris s.a.
• Investigators: Principal Investigator: Jan Tack, Professor, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: IBS; chitin-glucan
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: BK-IBS-2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No