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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
71
Patients will take Colilen IBS in First or Second Period
Patients will take PlaceboS in First or Second Period
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Germany
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy
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).
Time frame: 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)
Time frame: End of treatment (up to 5 months)
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.
Time frame: 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).
Time frame: 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
Time frame: 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;
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Ospedale SS. Annunziata
Chieti, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Policlinico Universitario A. Gemelli
Rome, Italy
IBS-SSS (Syndrome Severity Scoring) questionnaire sub score
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 month
Change from baseline halfway through treatment in: Bowel movement frequency in the clinical subgroup with a predominating bowel movement change;
Daily diary
Time frame: 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)
Time frame: 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
Time frame: 1 month
Change from baseline after treatment in the type and number of concomitant therapies taken for IBS symptoms.
number of concomitant therapies
Time frame: 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.
Time frame: End of treatment (up to 5 months)