Irritable Bowel SyndromeNCT05016024
Administration of a Molecular Complex of Resins, Polysaccharides and Polyphenols in Irritable Bowel Syndrome.
A study testing Colilen IBS in people with Irritable Bowel Syndrome, run by Aboca Spa Societa' Agricola at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Colilen IBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 5 Aug 2021to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Italy6 sites
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari
Azienda Ospedaliero Universitaria di Bologna
Bologna
Ospedale SS. Annunziata
Chieti
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
Policlinico Universitario A. Gemelli
Rome
Istituto Clinico Humanitas
Rozzano, Milano, 20089
About this study
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
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Colilen IBS, Placebo
- Keywords
- Irritable Bowel Syndrome, Colilen IBS, Abdominal Pain, IBS
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colilen IBSDevice
Patients will take Colilen IBS in First or Second Period
PlaceboOther
Patients will take PlaceboS in First or Second Period
| Study group | Role | What they receive |
|---|---|---|
| Colilen IBS + Placebo | Other | First Period: Colilen IBS Second Period: Placebo Receives: Device: Colilen IBS; Other: Placebo |
| Placebo + Colilen IBS | Other | First Period: Placebo Second Period: Colilen IBS Receives: Device: Colilen IBS; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: End of treatment (up to 5 months)
Secondary outcomes (15)
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.
Measured: 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:
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).
Measured: End of treatment (up to 5 months)
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
Measured: 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;
IBS-SSS (Syndrome Severity Scoring) questionnaire sub score
Measured: End of treatment (up to 5 months)
Change from baseline after treatment in: Quality of life as assessed by IBS-QoL (Quality of Life).
IBS-QoL Questionnaire
Measured: End of treatment (up to 5 months)
Change from baseline after treatment in the different clinical subgroups according to the presence of prevalent bowel changes, including: Bowel movement frequency;
Daily diary
Measured: End of treatment (up to 5 months)
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)
Measured: End of treatment (up to 5 months)
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
Measured: End of treatment (up to 5 months)
Change from baseline halfway through treatment in: IBS-SSS (Syndrome Severity Scoring) symptom severity score;
IBS-SSS (Syndrome Severity Scoring) questionnaire
Measured: 1 month
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
Measured: 1 month
Change from baseline halfway through treatment in: Bowel movement frequency in the clinical subgroup with a predominating bowel movement change;
Daily diary
Measured: 1 month
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)
Measured: 1 month
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
Measured: 1 month
Change from baseline after treatment in the type and number of concomitant therapies taken for IBS symptoms.
number of concomitant therapies
Measured: End of treatment (up to 5 months)
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.
Measured: End of treatment (up to 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start5 Aug 2021
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc., IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016024
- Sponsor's protocol ID
- ABO-COL-01/21
- Status last verified
- Feb 2023
- First submitted
- 25 May 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05016024
- Acronym / sponsor ID
- ABO-COL-01/21
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Colilen IBS, Abdominal Pain, IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc., IQVIA Pty Ltd
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Colilen IBS + Placebo | Other | Device: Colilen IBS, Other: PlaceboFirst Period: Colilen IBS Second Period: Placebo |
| Placebo + Colilen IBS | Other | Device: Colilen IBS, Other: PlaceboFirst Period: Placebo Second Period: Colilen IBS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colilen IBSPatients will take Colilen IBS in First or Second Period | Device | Colilen IBS + Placebo, Placebo + Colilen IBS |
| PlaceboPatients will take PlaceboS in First or Second Period | Other | Colilen IBS + Placebo, Placebo + Colilen IBS |
Primary outcome
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)
Time frame: End of treatment (up to 5 months)
The endpoint will be assessed through a 4-point Likert scale (minimum sum score: 0; maximun sum score:12).
Change from baseline after treatment in: Abdominal pain intensity sum score on an 11-point numeric rating scale, NRS (from 0 to 10).
Time frame: End of treatment (up to 5 months)
The endpoint will be assessed through an 11-point numeric rating scale (NRS, from 0 to 10)
15 secondary outcomes
Change from baseline in IBS-SSS (symptom severity score).
Time frame: 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:
Time frame: End of treatment (up to 5 months)
Time to adequate overall relief of IBS symptoms.
Time frame: 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;
Time frame: End of treatment (up to 5 months)
Change from baseline after treatment in: Quality of life as assessed by IBS-QoL (Quality of Life).
Time frame: End of treatment (up to 5 months)
Change from baseline after treatment in the different clinical subgroups according to the presence of prevalent bowel changes, including: Bowel movement frequency;
Time frame: End of treatment (up to 5 months)
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);
Time frame: End of treatment (up to 5 months)
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.
Time frame: End of treatment (up to 5 months)
Change from baseline halfway through treatment in: IBS-SSS (Syndrome Severity Scoring) symptom severity score;
Time frame: 1 month
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;
Time frame: 1 month
Change from baseline halfway through treatment in: Bowel movement frequency in the clinical subgroup with a predominating bowel movement change;
Time frame: 1 month
Change from baseline halfway through treatment in: Stool consistency according to the Bristol scale in the clinical subtype with a predominating bowel movement change.
Time frame: 1 month
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).
Time frame: 1 month
Change from baseline after treatment in the type and number of concomitant therapies taken for IBS symptoms.
Time frame: End of treatment (up to 5 months)
Incidence of AEs during study treatment
Time frame: End of treatment (up to 5 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colilen IBS in people with Irritable Bowel Syndrome, run by Aboca Spa Societa' Agricola at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: End of treatment (up to 5 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.