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CompletedNCT05016024Updated Feb 16, 2023

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

An interventional study of Colilen IBS and Placebo in Irritable Bowel Syndrome, sponsored by Aboca Spa Societa' Agricola. Completed at 7 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-16.

Sponsored by Aboca Spa Societa' Agricola · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • Irritable Bowel Syndrome
  • Colilen IBS
  • Abdominal Pain
  • IBS
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 71 is close to the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Aboca Spa Societa' Agricola is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Male or female patients aged 18 to 75 years (inclusive);
    1. Diagnosis of IBS according to ROME IV criteria (Appendix 3);
    1. 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;
    1. Signed Informed Consent;
    1. Patients' ability to comply with the study procedures;
    1. Stable diet in the two months prior to the screening visit;

    1. *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;

    1. 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

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.
    1. Patients taking tricyclic antidepressants within six months prior to the screening visit;
    1. Patients taking opioid-containing analgesics within one month prior to the screening visit;
    1. Patients taking antibiotics within one month prior to the screening visit;
    1. Patients with relevant organic, systemic or metabolic disease, or laboratory changes, that are deemed significant based on specific ranges of normality;
    1. Patients with organic bowel diseases;
    1. Patients with unstable psychiatric conditions;
    1. Patients who have undergone major abdominal surgery, except appendectomy;
    1. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
71 participants (actual)

Study arms

  • Other
    Colilen IBS + Placebo

    First Period: Colilen IBS Second Period: Placebo

    Device: Colilen IBS · Other: Placebo

  • Other
    Placebo + Colilen IBS

    First Period: Placebo Second Period: Colilen IBS

    Device: Colilen IBS · Other: Placebo

Interventions

  • DeviceColilen IBS

    Patients will take Colilen IBS in First or Second Period

  • OtherPlacebo

    Patients will take PlaceboS in First or Second Period

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: End of treatment (up to 5 months)

  2. 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)

    Time frame: End of treatment (up to 5 months)

Secondary outcomes

  1. 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.

    Time frame: End of treatment (up to 5 months)

  2. 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).

    Time frame: End of treatment (up to 5 months)

  3. 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

    Time frame: End of treatment (up to 5 months)

  4. 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

    Time frame: End of treatment (up to 5 months)

  5. Change from baseline after treatment in: Quality of life as assessed by IBS-QoL (Quality of Life).

    IBS-QoL Questionnaire

    Time frame: End of treatment (up to 5 months)

  6. Change from baseline after treatment in the different clinical subgroups according to the presence of prevalent bowel changes, including: Bowel movement frequency;

    Daily diary

    Time frame: End of treatment (up to 5 months)

  7. 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)

    Time frame: End of treatment (up to 5 months)

  8. 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

    Time frame: End of treatment (up to 5 months)

  9. Change from baseline halfway through treatment in: IBS-SSS (Syndrome Severity Scoring) symptom severity score;

    IBS-SSS (Syndrome Severity Scoring) questionnaire

    Time frame: 1 month

  10. 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

    Time frame: 1 month

  11. Change from baseline halfway through treatment in: Bowel movement frequency in the clinical subgroup with a predominating bowel movement change;

    Daily diary

    Time frame: 1 month

  12. 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)

    Time frame: 1 month

  13. 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

    Time frame: 1 month

  14. Change from baseline after treatment in the type and number of concomitant therapies taken for IBS symptoms.

    number of concomitant therapies

    Time frame: End of treatment (up to 5 months)

  15. 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.

    Time frame: End of treatment (up to 5 months)

07

Study locations

7 sites
  • Klinische Forschung Karlsruhe GmbH
    Karlsruhe, Germany
  • Istituto Clinico Humanitas
    Rozzano, Milano 20089, 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, 56124, Italy
  • Policlinico Universitario A. Gemelli
    Rome, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05016024
Lead sponsor
Aboca Spa Societa' Agricola
Collaborators
IQVIA RDS Inc., IQVIA Solutions
Responsible party
Sponsor
First posted
Aug 23, 2021
Start date
Aug 5, 2021
Primary completion
Feb 15, 2023
Completion
Feb 15, 2023
Last update
Feb 16, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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