Administration of a Natural Molecular Complex in Functional Chronic Constipation

NCT05192317 | Unknown

• 1 other identifier: ABO-SOLDM-02/21
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Constipation

Keywords

Chronic Constipation; Medical Device; Sollievo Fisiolax; Natural Molecular Complex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Patient satisfaction

  7 days, 14 days, 21 days, 28 days

• Change in Stool frequency

  through study completion, an average of 1 month

• Change in Patient Assessment of Constipation-Symptom

  14 days, 28 days

• Change in Stool consistency

  through study completion, an average of 1 month

• Change of strain evacuation

  through study completion, an average of 1 month

Study Arms (2)

Arm Sollievo Fisiolax

EXPERIMENTAL

Sollievo Fisiolax

Device: Sollievo Fisiolax

Arm Placebo

PLACEBO COMPARATOR

Placebo

Other: Sollievo Fisiolax Placebo

Interventions

Sollievo Fisiolax DEVICE

Class IIb Medical Device

Arm Sollievo Fisiolax

Sollievo Fisiolax Placebo OTHER

Placebo

Arm Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Patients undergoing gastro-intestinal resection
• Renal, hepatic, haematological, cardiovascular, pulmonary, neurological, psychiatric, immunological, endocrine diseases, if they are clinically significant
• 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.

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead
• JSB Solutions S.R.L.: collaborator

Study Sites (2)

Campus Biomedico

Rome, Lazio, 00128, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Milan, Lombardy, 20089, Italy

RECRUITING

Central Study Contacts

Caterina Fossi, Ph.D

CONTACT

+39 3351894461; cfossi@aboca.it

Luca Franceschini, Ph.D

CONTACT

+39 3386794491; lfranceschini@aboca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: January 14, 2022
• Study Start: November 9, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

IT (2)