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

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016024
• Other study ID #: ABO-COL-01/21
• Status: Completed
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2023
• Source: Aboca Spa Societa' Agricola
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Device:
• Colilen IBS
Patients will take Colilen IBS in First or Second Period

Other:
• Placebo
Patients will take PlaceboS in First or Second Period

Locations

Country	Name	City	State
Germany	Klinische Forschung Karlsruhe GmbH	Karlsruhe
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	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (3)

Lead Sponsor	Collaborator
Aboca Spa Societa' Agricola	IQVIA RDS, IQVIA Solutions

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	End of treatment (up to 5 months)
Secondary	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).	End of treatment (up to 5 months)
Secondary	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	End of treatment (up to 5 months)
Secondary	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;	IBS-SSS (Syndrome Severity Scoring) questionnaire sub score	End of treatment (up to 5 months)
Secondary	Change from baseline after treatment in: Quality of life as assessed by IBS-QoL (Quality of Life).	IBS-QoL Questionnaire	End of treatment (up to 5 months)
Secondary	Change from baseline after treatment in the different clinical subgroups according to the presence of prevalent bowel changes, including: Bowel movement frequency;	Daily diary	End of treatment (up to 5 months)
Secondary	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)	End of treatment (up to 5 months)
Secondary	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	End of treatment (up to 5 months)
Secondary	Change from baseline halfway through treatment in: IBS-SSS (Syndrome Severity Scoring) symptom severity score;	IBS-SSS (Syndrome Severity Scoring) questionnaire	1 month
Secondary	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	1 month
Secondary	Change from baseline halfway through treatment in: Bowel movement frequency in the clinical subgroup with a predominating bowel movement change;	Daily diary	1 month
Secondary	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)	1 month
Secondary	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	1 month
Secondary	Change from baseline after treatment in the type and number of concomitant therapies taken for IBS symptoms.	number of concomitant therapies	End of treatment (up to 5 months)
Secondary	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.	End of treatment (up to 5 months)