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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aboca Spa Societa' Agricola
- Enrollment
- 71
- Locations
- 7
- Primary Endpoint
- Change from baseline after treatment in: Abdominal pain intensity sum score on an 11-point numeric rating scale, NRS (from 0 to 10).
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients aged 18 to 75 years (inclusive);
- •Diagnosis of IBS according to ROME IV criteria (Appendix 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;
- •Signed Informed Consent;
- •Patients' ability to comply with the study procedures;
- •Stable diet in the two months prior to the screening visit;
- •*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;
- •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
- •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.
- •Patients taking tricyclic antidepressants within six months prior to the screening visit;
- •Patients taking opioid-containing analgesics within one month prior to the screening visit;
- •Patients taking antibiotics within one month prior to the screening visit;
- •Patients with relevant organic, systemic or metabolic disease, or laboratory changes, that are deemed significant based on specific ranges of normality;
- •Patients with organic bowel diseases;
- •Patients with unstable psychiatric conditions;
- •Patients who have undergone major abdominal surgery, except appendectomy;
- •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.
Arms & Interventions
Colilen IBS + Placebo
First Period: Colilen IBS Second Period: Placebo
Intervention: Colilen IBS (Device)
Colilen IBS + Placebo
First Period: Colilen IBS Second Period: Placebo
Intervention: Placebo (Other)
Placebo + Colilen IBS
First Period: Placebo Second Period: Colilen IBS
Intervention: Colilen IBS (Device)
Placebo + Colilen IBS
First Period: Placebo Second Period: Colilen IBS
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change from baseline after treatment in: Abdominal pain intensity sum score on an 11-point numeric rating scale, NRS (from 0 to 10).
Time Frame: End of treatment (up to 5 months)
The endpoint will be assessed through an 11-point numeric rating scale (NRS, from 0 to 10)
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)
Time Frame: End of treatment (up to 5 months)
The endpoint will be assessed through a 4-point Likert scale (minimum sum score: 0; maximun sum score:12).
Secondary Outcomes
- Change from baseline after treatment in: Quality of life as assessed by IBS-QoL (Quality of Life).(End of treatment (up to 5 months))
- Change from baseline halfway through treatment in: IBS-SSS (Syndrome Severity Scoring) symptom severity score;(1 month)
- 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:(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;(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.(End of treatment (up to 5 months))
- Incidence of AEs during study treatment(End of treatment (up to 5 months))
- Change from baseline in IBS-SSS (symptom severity score).(End of treatment (up to 5 months))
- Time to adequate overall relief of IBS symptoms.(End of treatment (up to 5 months))
- 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;(1 month)
- Change from baseline halfway through treatment in: Bowel movement frequency in the clinical subgroup with a predominating bowel movement change;(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).(1 month)
- Change from baseline after treatment in the type and number of concomitant therapies taken for IBS symptoms.(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;(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);(End of treatment (up to 5 months))
- Change from baseline halfway through treatment in: Stool consistency according to the Bristol scale in the clinical subtype with a predominating bowel movement change.(1 month)