Chronic ConstipationNCT05192317
Administration of a Natural Molecular Complex in Functional Chronic Constipation
A study testing Sollievo Fisiolax in people with Chronic Constipation, run by Aboca Spa Societa' Agricola at 2 sites in Italy.
Trial summary
This is a multi-center, randomized, double-blinded placebo controlled trial to evaluate the efficacy and safety of the substance-based medical device (Sollievo Fisiolax) in the treatment of Chronic Constipation. Treatment period for each patient is 28 days. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Sollievo Fisiolax
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesItaly
- Study dates
- 9 Nov 2021to 30 Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient giving written informed consent to participate in the study.
- Patient of both sexes aged between 18 and 70 years (inclusive)
- Patient affected by chronic functional constipation according to the Rome IV criteria
- In patients over the age of 50, negative colonoscopy, i.e. absence of clinically relevant alterations or in any case of critical condition for study participation, performed during the run-in period unless:
- at least negative colonoscopy performed in the previous 5 years the symptoms have remained unchanged, if present, from the time of the execution of the (or last, if more than one) colonoscopy
Who cannot join
- Hypersensitivity or Suspected or known allergy to one of the components of the products under study
- Have previously taken the study product
- Therapy with antibiotics within 4 weeks prior to the screening visit (i.e, prior to the visit V -1)
- Therapy within 2 weeks of the run-in (i.e., prior to the visit V0) with: Laxatives / fecal softeners / intestinal bulking products; Drugs indicated for the treatment of obesity; probiotics or prebiotics
- Chronic inflammatory bowel diseases
- Intestinal diseases of infectious, actinic, endocrine or pharmacologic origin (microscopic colitis)
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- Patients undergoing gastro-intestinal resection
- Renal, hepatic, haematological, cardiovascular, pulmonary, neurological, psychiatric, immunological, endocrine diseases, if they are clinically significant
- Patients with malignant neoplasm of any type, or history of malignancy, with the exclusion of patients with a history of extra-intestinal malignant neoplasm surgically removed and no evidence of recurrence within the five years prior to participation
- Abuse of alcohol, narcotics or psychotropic drugs that can change vigilance and physical perception
- Presence of a dementia of any type or other possible causes of progressive deterioration of the capacity to understand and of want or psycho-physical disability that reduces the ability to assume as expected the study treatment
- Obesity (BMI ≥ 30)
- No adequate reliability or conditions that may lead to a non-compliance / adherence of the patient to the protocol
- Previous participation in a clinical trial in the last 30 days
- Patients who for any reason do not agree to guarantee the commitment to keep their diet stable for the study period
- During the run-in period, in case of severe symptoms, the use of an evacuant to be applied rectally, indicated in constipation and identified by the Investigator, can be used as a "rescue" therapy.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Istituto Clinico Humanitas
Milan, Lombardy, 20089
Alessandro Repici, Professor, +39 0282244507, alessandro.repici@hunimed.eu
- Recruiting
Campus Biomedico
Rome, Lazio, 00128
Michele Guarino, Professor, m.guarino@unicampus.it
About this study
Official title: A Randomized, Parallel Group, Placebo-controlled, Double Blinded Clinical Trial to Evaluate the Efficacy and Safety of the Substance-based Medical Device (Sollievo Fisiolax) in the Treatment of Chronic Constipation.
This is a multi-center, randomized, double-blinded placebo controlled trial to evaluate the efficacy and safety of the substance-based medical device (Sollievo Fisiolax) in the treatment of Chronic Constipation.
Treatment period for each patient is 28 days.
Read the detailed description
According to the criteria of Rome IV, 86 patients diagnosed from chronic constipation will be enrolled by up to ten centers.
The study includes 2 visits at the site center and 1 by phone call.
V-1 (eligibility assessment / screening visit):
- Collection of written informed consent
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Diagnosis according to Rome IV criteria of chronic functional constipation
- Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis.
- Performing a colonoscopy for patients aged> 50 who have not had one performed in the last 5 years.
- Guideline for daily diary to collect the number and the consistency of the evacuations, and whether or not they occur with effort
- Recording of adverse events and concomitant therapies
V0 (confirmation of possession of selection criteria):
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Randomization 1:1 to Sollievo Fisiolax or Placebo
- Blood and fecal sample collection for the evaluations of the exploratory objectives
- Compliance of the daily diary
- Administration of questionnaires: Gastrointestinal Quality of Life Index (GIQLI), PAC-SYM
- Any changes in concomitant therapies and any adverse events will be recorded.
V1 (end of treatment or discontinuation before study / treatment time; 4 weeks after V0):
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Returned the Investigational product
- Blood and fecal sample collection for the evaluations of the exploratory objectives.
- Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis.
- Blood sampling for the screening of HIV, HCV, HBV and TPHA
- Check of daily diary
- Administration of questionnaires: Gastrointestinal Quality of Life Index (GIQLI), PAC-SYM
- Any changes in concomitant therapies and any adverse events will be recorded
- Conditions
- Chronic Constipation
- Being tested
- Sollievo Fisiolax, Sollievo Fisiolax Placebo
- Keywords
- Chronic Constipation, Medical Device, Sollievo Fisiolax, Natural Molecular Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sollievo FisiolaxDevice
Class IIb Medical Device
Sollievo Fisiolax PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm Sollievo Fisiolax | Experimental | Sollievo Fisiolax Receives: Device: Sollievo Fisiolax |
| Arm Placebo | Placebo comparator | Placebo Receives: Other: Sollievo Fisiolax Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of spontaneous complete bowel movement
Response rate (RR) to study treatment, defined by an increase of at least 1 spontaneous complete bowel movement, (SCBM) / weekly from baseline, in at least 75% of the weeks of the treatment period
Measured: 28 days
Secondary outcomes (9)
Patient satisfaction
Composite rate of satisfaction with the treatment and improvement of the symptom complex, with "satisfaction" and "improvement" defined respectively by:
- a ˃4 score on the following 7-point Likert scale of "satisfaction with treatment":
- = extremely dissatisfied,
- = very dissatisfied,
- = dissatisfied,
- = partially satisfied,
- = satisfied,
- = very satisfied,
- = extremely satisfied
- a score ≥2 on a global change rating scale (-7 to +7: -7 = extremely worsened, 0 = unchanged, +7 = extremely improved).
Measured: 7 days, 14 days, 21 days, 28 days
Change in Stool frequency
Post treatment stool frequency increase respect to the Baseline
Measured: through study completion, an average of 1 month
Change in Patient Assessment of Constipation-Symptom
Reduction of Patient Assessment of Constipation-Symptom (PAC-SYM) questionnaire, a 12-item questionnaire divided into three symptom subscales: abdominal (four items), rectal (three items) and stool (five items). Each item is scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A score reduction represents an improvement of constipation symptoms.
Measured: 14 days, 28 days
Change in Stool consistency
Change in the stool consistency assessed through the 7-point Bristol Stool Form Scale (type 1, type 2, type 3, type 4, type 5, type 6, type 7).
Measured: through study completion, an average of 1 month
Change of strain evacuation
Reduction of number of evacuation with strain
Measured: through study completion, an average of 1 month
Rescue medication
Number of patients who used the rescue medication, nunmber of rescue medication consumed and frequency of use
Measured: through study completion, an average of 1 month
Change of Quality of Life (QoL)
Improvement of QoL through Gastrointestinal Quality of Life Index questionnaire (GIQLI). GiQLI is a 36-item questionnaire, Each item is scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'all the time', 1 = 'most of the time', 2 = 'now and then', 3 = 'rarely' and 4 = 'never'). A score increase represents an improvement of QoL.
Measured: 14 days, 28 days
Incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, incidence of patients dropped outs.
Incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, incidence of patients dropped outs.
Measured: through study completion, an average of 1 month
Change of strain evacuation
Time to event (cox ratio), defined as the first week during which more than 50% of evacuations occurred without strain.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start9 Nov 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSB Solutions S.R.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192317
- Sponsor's protocol ID
- ABO-SOLDM-02/21
- Status last verified
- Jul 2023
- First submitted
- 22 Oct 2021
- Last updated
- 14 Jul 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group, Placebo-controlled, Double Blinded Clinical Trial to Evaluate the Efficacy and Safety of the Substance-based Medical Device (Sollievo Fisiolax) in the Treatment of Chronic Constipation.
- ClinicalTrials.gov ID
- NCT05192317
- Acronym / sponsor ID
- ABO-SOLDM-02/21
- Conditions
- Chronic Constipation
- Keywords
- Chronic Constipation, Medical Device, Sollievo Fisiolax, Natural Molecular Complex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- JSB Solutions S.R.L.
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 14 Jan 2022 (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 is a multi-center, randomized, double-blinded placebo controlled trial to evaluate the efficacy and safety of the substance-based medical device (Sollievo Fisiolax) in the treatment of Chronic Constipation.
Treatment period for each patient is 28 days.
Detailed description
According to the criteria of Rome IV, 86 patients diagnosed from chronic constipation will be enrolled by up to ten centers.
The study includes 2 visits at the site center and 1 by phone call.
V-1 (eligibility assessment / screening visit):
- Collection of written informed consent
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Diagnosis according to Rome IV criteria of chronic functional constipation
- Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis.
- Performing a colonoscopy for patients aged> 50 who have not had one performed in the last 5 years.
- Guideline for daily diary to collect the number and the consistency of the evacuations, and whether or not they occur with effort
- Recording of adverse events and concomitant therapies
V0 (confirmation of possession of selection criteria):
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Randomization 1:1 to Sollievo Fisiolax or Placebo
- Blood and fecal sample collection for the evaluations of the exploratory objectives
- Compliance of the daily diary
- Administration of questionnaires: Gastrointestinal Quality of Life Index (GIQLI), PAC-SYM
- Any changes in concomitant therapies and any adverse events will be recorded.
V1 (end of treatment or discontinuation before study / treatment time; 4 weeks after V0):
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Returned the Investigational product
- Blood and fecal sample collection for the evaluations of the exploratory objectives.
- Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis.
- Blood sampling for the screening of HIV, HCV, HBV and TPHA
- Check of daily diary
- Administration of questionnaires: Gastrointestinal Quality of Life Index (GIQLI), PAC-SYM
- Any changes in concomitant therapies and any adverse events will be recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Sollievo Fisiolax | Experimental | Device: Sollievo FisiolaxSollievo Fisiolax |
| Arm Placebo | Placebo comparator | Other: Sollievo Fisiolax PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient giving written informed consent to participate in the study.
- Patient of both sexes aged between 18 and 70 years (inclusive)
- Patient affected by chronic functional constipation according to the Rome IV criteria
- In patients over the age of 50, negative colonoscopy, i.e. absence of clinically relevant alterations or in any case of critical condition for study participation, performed during the run-in period unless:
- at least negative colonoscopy performed in the previous 5 years the symptoms have remained unchanged, if present, from the time of the execution of the (or last, if more than one) colonoscopy
Key exclusion criteria (16 listed)
- Hypersensitivity or Suspected or known allergy to one of the components of the products under study
- Have previously taken the study product
- Therapy with antibiotics within 4 weeks prior to the screening visit (i.e, prior to the visit V -1)
- Therapy within 2 weeks of the run-in (i.e., prior to the visit V0) with: Laxatives / fecal softeners / intestinal bulking products; Drugs indicated for the treatment of obesity; probiotics or prebiotics
- Chronic inflammatory bowel diseases
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 |
|---|---|---|
| Sollievo FisiolaxClass IIb Medical Device | Device | Arm Sollievo Fisiolax |
| Sollievo Fisiolax PlaceboPlacebo | Other | Arm Placebo |
Primary outcome
Change in the number of spontaneous complete bowel movement
Time frame: 28 days
Response rate (RR) to study treatment, defined by an increase of at least 1 spontaneous complete bowel movement, (SCBM) / weekly from baseline, in at least 75% of the weeks of the treatment period
9 secondary outcomes
Patient satisfaction
Time frame: 7 days, 14 days, 21 days, 28 days
Change in Stool frequency
Time frame: through study completion, an average of 1 month
Change in Patient Assessment of Constipation-Symptom
Time frame: 14 days, 28 days
Change in Stool consistency
Time frame: through study completion, an average of 1 month
Change of strain evacuation
Time frame: through study completion, an average of 1 month
Rescue medication
Time frame: through study completion, an average of 1 month
Change of Quality of Life (QoL)
Time frame: 14 days, 28 days
Incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, incidence of patients dropped outs.
Time frame: through study completion, an average of 1 month
Change of strain evacuation
Time frame: through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sollievo Fisiolax in people with Chronic Constipation, run by Aboca Spa Societa' Agricola at 2 sites in Italy.
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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caterina Fossi, Ph.D (+39 3351894461, cfossi@aboca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of spontaneous complete bowel movement (time frame: 28 days). 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 14 Jul 2023.