Clinical trial NCT05780749: A 14-week Pilot Prospective Clinical Trial With BiOkuris Product in Patients With Irritable Bowel Syndrome
Official title: A 14-week Pilot Prospective Clinical Trial With BiOkuris Product in Patients With Irritable Bowel Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: IBS
chitin-glucan
Lead sponsor: Biokuris s.a.
Sponsor class: INDUSTRY
First posted: 2023-03-23
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Symptoms global assessment of relief (SGA) responder rate
timeFrame: Week 10 (8 weeks after run-in period)
Secondary outcomes:
measure: Weekly SGA responder rate
timeFrame: weekly from week 2 to week 14
measure: Individual symptoms
timeFrame: weekly from week 2 to week 14
measure: stool consistency
timeFrame: weekly from week 2 to week 14
measure: number of evacuation per day
timeFrame: weekly from week 2 to week 14
measure: IBS-QoL
timeFrame: Week 0, week 4, week 8, week 10, week 14
measure: Anxiety & Depression
timeFrame: Week 0, week 4, week 8, week 10, week 14
measure: Adverse events
timeFrame: Week 0, week 2, week 4, week 8, week 10, week 14
Other outcomes:
Locations:
city: Ath
country: Belgium
facility: Centre Hospitalier EpiCURA
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Bruxelles
country: Belgium
facility: CUB Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Jette
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU Liege
city: Liege
country: Belgium
facility: Clinique CHC Mont-Legia
city: Seraing
country: Belgium
facility: Centre Hospitalier du Bois de l'Abbaye
Study officials:
affiliation: UZ Leuven
name: Jan Tack, Professor
role: PRINCIPAL_INVESTIGATOR
References: