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

NCT05016024 | Completed

• 1 other identifier: ABO-COL-01/21
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 7

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Colilen IBS; Abdominal Pain; IBS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Change from baseline in IBS-SSS (symptom severity score).

  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:

  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 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: Quality of life as assessed by IBS-QoL (Quality of Life).

  End of treatment (up to 5 months)

Study Arms (2)

Colilen IBS + Placebo

OTHER

First Period: Colilen IBS Second Period: Placebo

Device: Colilen IBS; Other: Placebo

Placebo + Colilen IBS

OTHER

First Period: Placebo Second Period: Colilen IBS

Device: Colilen IBS; Other: Placebo

Interventions

Colilen IBS DEVICE

Patients will take Colilen IBS in First or Second Period

Colilen IBS + Placebo; Placebo + Colilen IBS

Placebo OTHER

Patients will take PlaceboS in First or Second Period

Colilen IBS + Placebo; Placebo + Colilen IBS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.
• Women with known or planned pregnancy or breastfeeding;
• 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.

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead
• IQVIA RDS Inc.: collaborator
• IQVIA Solutions: collaborator

Study Sites (7)

Klinische Forschung Karlsruhe GmbH

Karlsruhe, Germany

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

Location

Azienda Ospedaliero Universitaria di Bologna

Bologna, Italy

Location

Ospedale SS. Annunziata

Chieti, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Location

Policlinico Universitario A. Gemelli

Rome, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: August 23, 2021
• Study Start: August 5, 2021
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

IT (6); DE (1)