Administration of a Molecular Complex of Resins, Polysaccharides and Polyphenols in Irritable Bowel Syndrome.

Study Overview
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Brief Summary
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This study is aimed to investigate the efficacy and safety of Colilen IBS, a Medical Device made of natural substances, even when taken in addition to other therapies, for the treatment of Irritable Bowel Syndrome.

Detailed Description
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This is a Post Market, randomized, double blind, cross-over clinical evaluation that will be conducted in 66 patients with diagnosis of Irritable Bowel Syndrome according to Rome IV criteria. As this is a cross-over clinical investigation, each eligible patient will take both the products under investigation, Colilen IBS and its Placebo. After a 2-week run-in period, at Baseline visit each patient included in the study will be randomly assigned to one of the two treatment sequences (i.e., Sequence AB and Sequence BA), for a 16-week total sequential treatment period (8 weeks for each of the 2 treatment periods) first with verum Colilen IBS and then with its Placebo, or vice versa. A wash out period (3 weeks) is forecast between the two treatment periods.

Official Title
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A Randomized, Cross-over, Placebo-Controlled, Double-Blind Clinical Trial on the Efficacy and Safety of Oral Administration of a Molecular Complex of Resins, Polysaccharides and Polyphenols in the Treatment of Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Device: Colilen IBS
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Male or female patients aged 18 to 75 years (inclusive); 2. Diagnosis of IBS according to ROME IV criteria (Appendix 3); 3. Abdominal pain score ≥ 4 on a 11-point NRS, on at least 2 days of the 14 days prior to the baseline visit and on at least 2 days of the last 14 days of the washout period, and pain score not > 8 in more than 7 days of each of the two above-mentioned periods; 4. Signed Informed Consent; 5. Patients' ability to comply with the study procedures; 6. Stable diet in the two months prior to the screening visit; 7. *Negative colonoscopy, defined as the absence of clinically relevant changes or of changes nonetheless relevant in relation to study participation risk, performed during the run-in period, unless: a colonoscopy was performed within the previous 5 years and was negative as intended above, or, if more than one was performed within the previous 5 years, the last being negative as intended above; the symptoms, if any, for which the last colonoscopy was performed, have remained unchanged; 8. Postmenopausal female patients, i.e., females who have not had a menstrual period for at least 12 months or women who have undergone surgical sterilisation (tubal ligation or ovary removal). If not, women of childbearing potential must follow reliable contraceptive treatment. Inclusion criteria applicable only for patients > 50 years of age Exclusion Criteria: 1. Patients taking treatments that may significantly affect the efficacy outcomes measures, such as: probiotics and prebiotics (unless contained in milk-derived foods such as yogurt and cheese); drugs with adsorbent/sequestrant properties such as diosmectite; 5-HT3 receptor antagonist drugs, e.g. ondasetron; drugs that modify gastro-intestinal motility, e.g. final anti-cholinergic agents such as loperamide, or cholinergic agents; laxatives and faecal softeners) unless they have been taken at a stable dose for at least four weeks prior to the screening visit. 2. Patients taking tricyclic antidepressants within six months prior to the screening visit; 3. Patients taking opioid-containing analgesics within one month prior to the screening visit; 4. Patients taking antibiotics within one month prior to the screening visit; 5. Patients with relevant organic, systemic or metabolic disease, or laboratory changes, that are deemed significant based on specific ranges of normality; 6. Patients with organic bowel diseases; 7. Patients with unstable psychiatric conditions; 8. Patients who have undergone major abdominal surgery, except appendectomy; 9. Known hypersensitivity to one or more of the components of the products. 10.Women with known or planned pregnancy or breastfeeding; 11.Patients with malignancies of any type, or with a history of prior malignancies, except for patients with a history of extra-intestinal malignancies that have been surgically removed and have not relapsed within the five years prior to participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Run in period: 2 weeks First Period: two months of treatment with Colilen IBS or Placebo, based on the randomization at Baseline visit Wash out period:3 weeks Second Period: two months of treatment with Colilen IBS or Placebo, based on the randomization at Baseline visit
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Colilen IBS + Placebo<br>First Period: Colilen IBS Second Period: Placebo | Device: Colilen IBS<br>* Patients will take Colilen IBS in First or Second Period<br>Other: Placebo<br>* Patients will take PlaceboS in First or Second Period<br>|
| Other: Placebo + Colilen IBS<br>First Period: Placebo Second Period: Colilen IBS | Device: Colilen IBS<br>* Patients will take Colilen IBS in First or Second Period<br>Other: Placebo<br>* Patients will take PlaceboS in First or Second Period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline after treatment in: Symptom intensity sum score (flatulence/meteorism, feeling of turgidity or fullness, feeling of incomplete evacuation, changes in bowel habit) | The endpoint will be assessed through a 4-point Likert scale (minimum sum score: 0; maximun sum score:12). | End of treatment (up to 5 months) | 
| Change from baseline after treatment in: Abdominal pain intensity sum score on an 11-point numeric rating scale, NRS (from 0 to 10). | The endpoint will be assessed through an 11-point numeric rating scale (NRS, from 0 to 10) | End of treatment (up to 5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in IBS-SSS (symptom severity score). | Irritable Bowel Syndrome-Severity Scored System (IBS-SSS) questionnaire. The maximum achievable score is 500. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and > 300 respectively. | End of treatment (up to 5 months) | 
| Change of adequate overall symptom relief after treatment, defined by a score of at least 3 on a 7-point Likert scale of weekly relief, in at least 50% of treatment weeks: | 7-point Likert Scale Possible answers: 1, very relieved; 2, relieved; 3, somewhat relieved; 4, unchanged; 5, slightly worsened; 6, worsened; 7, much worsened (7-point Likert Scale). | End of treatment (up to 5 months) | 
| Time to adequate overall relief of IBS symptoms. | Score of a 7-point Likert scale 7-point Likert Scale Possible answers: 1, very relieved; 2, relieved; 3, somewhat relieved; 4, unchanged; 5, slightly worsened; 6, worsened; 7, much worsened | End of treatment (up to 5 months) | 
| Change from baseline after treatment in: o Severity score of each of the individual symptoms included in the IBS-SSS (sub-scores), assessed by a NRS from 0 to 100; | IBS-SSS (Syndrome Severity Scoring) questionnaire sub score | End of treatment (up to 5 months) | 
| Change from baseline after treatment in: Quality of life as assessed by IBS-QoL (Quality of Life). | IBS-QoL Questionnaire | End of treatment (up to 5 months) | 
| Change from baseline after treatment in the different clinical subgroups according to the presence of prevalent bowel changes, including: Bowel movement frequency; | Daily diary | End of treatment (up to 5 months) | 
| Change from baseline after treatment in the different clinical subgroups according to the presence of prevalent bowel changes, including: Stool consistency according to Bristol stool form scale (BSFS); | BSFS (Bristol Stool Form Scale) | End of treatment (up to 5 months) | 
| Change from baseline after treatment in the different clinical subgroups according to the presence of prevalent bowel changes, including: IBS-SSS NRS sub-score of bowel movement satisfaction. | IBS-SSS (Syndrome Severity Scoring) questionnaire | End of treatment (up to 5 months) | 
| Change from baseline halfway through treatment in: IBS-SSS (Syndrome Severity Scoring) symptom severity score; | IBS-SSS (Syndrome Severity Scoring) questionnaire | 1 month | 
| Change from baseline halfway through treatment in: Severity score of each of the individual symptoms included in the IBS-SSS (sub-scores), assessed by a NRS from 0 to 100; | IBS-SSS (Syndrome Severity Scoring) questionnaire | 1 month | 
| Change from baseline halfway through treatment in: Bowel movement frequency in the clinical subgroup with a predominating bowel movement change; | Daily diary | 1 month | 
| Change from baseline halfway through treatment in: Stool consistency according to the Bristol scale in the clinical subtype with a predominating bowel movement change. | BSFS (Bristol Stool Form Scale) | 1 month | 
| Change from baseline halfway through treatment in: IBS-SSS NRS sub-score of bowel movement satisfaction in the clinical subtype with no predominating bowel changes, i.e., IBS-M (mixed) and IBS-U (unclassified). | IBS-SSS (Syndrome Severity Scoring) questionnaire | 1 month | 
| Change from baseline after treatment in the type and number of concomitant therapies taken for IBS symptoms. | number of concomitant therapies | End of treatment (up to 5 months) | 
| Incidence of AEs during study treatment | Incidence and type of adverse events (AEs) and serious adverse events (SAEs) reported during study treatment. Safety will be assessed on the basis of all AEs experienced during study treatment. Furthermore, change from baseline in safety laboratory parameters and clinical examination findings (including measurement of anthropometric parameters and vital signs such as systolic/diastolic blood pressure, pulse, weight) will be assessed. | End of treatment (up to 5 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Colilen IBS, Abdominal Pain, IBS