Clinical trial NCT05016024: Administration of a Molecular Complex of Resins, Polysaccharides and Polyphenols in Irritable Bowel Syndrome.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Colilen IBS
Abdominal Pain
IBS
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: IQVIA RDS Inc.
name: IQVIA Solutions
First posted: 2021-08-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: End of treatment (up to 5 months)
measure: Change from baseline after treatment in: Abdominal pain intensity sum score on an 11-point numeric rating scale, NRS (from 0 to 10).
timeFrame: End of treatment (up to 5 months)
Secondary outcomes:
measure: Change from baseline in IBS-SSS (symptom severity score).
timeFrame: End of treatment (up to 5 months)
measure: 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:
timeFrame: End of treatment (up to 5 months)
measure: Time to adequate overall relief of IBS symptoms.
timeFrame: End of treatment (up to 5 months)
measure: 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;
timeFrame: End of treatment (up to 5 months)
measure: Change from baseline after treatment in: Quality of life as assessed by IBS-QoL (Quality of Life).
timeFrame: End of treatment (up to 5 months)
measure: Change from baseline after treatment in the different clinical subgroups according to the presence of prevalent bowel changes, including: Bowel movement frequency;
timeFrame: End of treatment (up to 5 months)
measure: 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);
timeFrame: End of treatment (up to 5 months)
measure: 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.
timeFrame: End of treatment (up to 5 months)
measure: Change from baseline halfway through treatment in: IBS-SSS (Syndrome Severity Scoring) symptom severity score;
timeFrame: 1 month
measure: 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;
timeFrame: 1 month
measure: Change from baseline halfway through treatment in: Bowel movement frequency in the clinical subgroup with a predominating bowel movement change;
timeFrame: 1 month
measure: Change from baseline halfway through treatment in: Stool consistency according to the Bristol scale in the clinical subtype with a predominating bowel movement change.
timeFrame: 1 month
measure: 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).
timeFrame: 1 month
measure: Change from baseline after treatment in the type and number of concomitant therapies taken for IBS symptoms.
timeFrame: End of treatment (up to 5 months)
measure: Incidence of AEs during study treatment
timeFrame: End of treatment (up to 5 months)
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Klinische Forschung Karlsruhe GmbH
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna
city: Chieti
country: Italy
facility: Ospedale SS. Annunziata
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Rome
country: Italy
facility: Policlinico Universitario A. Gemelli
Study officials:
References: