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

NCT ID: NCT05016024

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2023-02-15

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Colilen IBS + Placebo

First Period: Colilen IBS Second Period: Placebo

Group Type: OTHER

Colilen IBS

Intervention Type: DEVICE

Patients will take Colilen IBS in First or Second Period

Placebo

Intervention Type: OTHER

Patients will take PlaceboS in First or Second Period

Placebo + Colilen IBS

First Period: Placebo Second Period: Colilen IBS

Group Type: OTHER

Colilen IBS

Intervention Type: DEVICE

Patients will take Colilen IBS in First or Second Period

Placebo

Intervention Type: OTHER

Patients will take PlaceboS in First or Second Period

Interventions

Colilen IBS

Patients will take Colilen IBS in First or Second Period

Intervention Type: DEVICE

Placebo

Patients will take PlaceboS in First or Second Period

Intervention Type: OTHER

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IQVIA RDS Inc.

INDUSTRY

Sponsor Role: collaborator

IQVIA Solutions

UNKNOWN

Sponsor Role: collaborator

Aboca Spa Societa' Agricola

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Ospedale SS. Annunziata

Chieti, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Policlinico Universitario A. Gemelli

Rome, , Italy

Countries

Germany; Italy

Other Identifiers

ABO-COL-01/21

Identifier Type: -

Identifier Source: org_study_id