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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780749
• Other study ID #: BK-IBS-2301
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2024
• Source: Biokuris s.a.
• Contact: Salvatore Modica
• Phone: +32 4 259 85 00
• Email: s.modica[@]biokuris.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

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

Locations

Country	Name	City	State
Belgium	Centre Hospitalier EpiCURA	Ath
Belgium	AZ Sint-Jan	Brugge
Belgium	AZ Sint-Lucas	Brugge
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	CUB Hôpital Erasme	Bruxelles
Belgium	AZ Sint-Lucas	Gent
Belgium	UZ Brussel	Jette
Belgium	UZ Leuven	Leuven
Belgium	CHU Liege	Liege
Belgium	Clinique CHC Mont-Legia	Liege
Belgium	Centre Hospitalier du Bois de l'Abbaye	Seraing

Sponsors (1)

Lead Sponsor	Collaborator
Biokuris s.a.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	occurrence and severity of adverse events	Week 0, week 2, week 4, week 8, week 10, week 14