Clinical trial NCT05192317: Administration of a Natural Molecular Complex in Functional Chronic Constipation
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Constipation
Keywords: Chronic Constipation
Medical Device
Sollievo Fisiolax
Natural Molecular Complex
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: JSB Solutions S.R.L.
First posted: 2022-01-14
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

1. Patient giving written informed consent to participate in the study.
2. Patient of both sexes aged between 18 and 70 years (inclusive)
3. Patient affected by chronic functional constipation according to the Rome IV criteria
4. 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

Exclusion Criteria:

1. Hypersensitivity or Suspected or known allergy to one of the components of the products under study
2. Have previously taken the study product
3. Therapy with antibiotics within 4 weeks prior to the screening visit (i.e, prior to the visit V -1)
4. 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
5. Chronic inflammatory bowel diseases
6. Intestinal diseases of infectious, actinic, endocrine or pharmacologic origin (microscopic colitis)
7. Patients undergoing gastro-intestinal resection
8. Renal, hepatic, haematological, cardiovascular, pulmonary, neurological, psychiatric, immunological, endocrine diseases, if they are clinically significant
9. 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
10. Abuse of alcohol, narcotics or psychotropic drugs that can change vigilance and physical perception
11. 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
12. Obesity (BMI ≥ 30)
13. No adequate reliability or conditions that may lead to a non-compliance / adherence of the patient to the protocol
14. Previous participation in a clinical trial in the last 30 days
15. 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.

Primary outcomes:
measure: Change in the number of spontaneous complete bowel movement
timeFrame: 28 days
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 7 days, 14 days, 21 days, 28 days
measure: Change in Stool frequency
timeFrame: through study completion, an average of 1 month
measure: Change in Patient Assessment of Constipation-Symptom
timeFrame: 14 days, 28 days
measure: Change in Stool consistency
timeFrame: through study completion, an average of 1 month
measure: Change of strain evacuation
timeFrame: through study completion, an average of 1 month
measure: Rescue medication
timeFrame: through study completion, an average of 1 month
measure: Change of Quality of Life (QoL)
timeFrame: 14 days, 28 days
measure: Incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, incidence of patients dropped outs.
timeFrame: through study completion, an average of 1 month
measure: Change of strain evacuation
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Campus Biomedico
state: Lazio
city: Milano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
state: Lombardia
Study officials:
References: