Administration of a Natural Molecular Complex in Functional Chronic Constipation

Chronic Constipation Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192317
• Other study ID #: ABO-SOLDM-02/21
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: Aboca Spa Societa' Agricola
• Contact: Caterina Fossi, Ph.D
• Phone: +39 3351894461
• Email: cfossi[@]aboca.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Device:
• Sollievo Fisiolax
Class IIb Medical Device

Other:
• Sollievo Fisiolax Placebo
Placebo

Locations

Country	Name	City	State
Italy	IRCCS Istituto Clinico Humanitas	Milano	Lombardia
Italy	Campus Biomedico	Roma	Lazio

Sponsors (2)

Lead Sponsor	Collaborator
Aboca Spa Societa' Agricola	JSB Solutions S.R.L.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days
Secondary	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).	7 days, 14 days, 21 days, 28 days
Secondary	Change in Stool frequency	Post treatment stool frequency increase respect to the Baseline	through study completion, an average of 1 month
Secondary	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.	14 days, 28 days
Secondary	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).	through study completion, an average of 1 month
Secondary	Change of strain evacuation	Reduction of number of evacuation with strain	through study completion, an average of 1 month
Secondary	Rescue medication	Number of patients who used the rescue medication, nunmber of rescue medication consumed and frequency of use	through study completion, an average of 1 month
Secondary	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.	14 days, 28 days
Secondary	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.	through study completion, an average of 1 month
Secondary	Change of strain evacuation	Time to event (cox ratio), defined as the first week during which more than 50% of evacuations occurred without strain.	through study completion, an average of 1 month