Natural treatment for chronic constipation
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 study is testing a natural treatment called Sollievo Fisiolax to see if it can help people with chronic constipation feel better over 28 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Aboca Spa Societa' Agricola Industry-sponsored |
| Locations | 2 sites (Roma, Lazio and 1 other locations) |
| Trial ID | NCT05192317 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a natural molecular complex, Sollievo Fisiolax, in treating chronic constipation. It is a multi-center, randomized, double-blinded, placebo-controlled trial involving 86 patients diagnosed with chronic functional constipation according to Rome IV criteria. Participants will undergo a treatment period of 28 days, with two site visits and one phone call for follow-up. The study includes comprehensive assessments such as physical examinations, blood tests, and daily diaries to track bowel movements and symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who have been diagnosed with chronic functional constipation.
Not a fit: Patients with known allergies to the study components or those who have recently undergone antibiotic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a natural and effective option for patients suffering from chronic constipation.
How similar studies have performed: Other studies have shown promise with similar natural treatments for gastrointestinal issues, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma, Lazio and 1 other locations
- Campus Biomedico — Roma, Lazio, Italy (Recruiting)
- IRCCS Istituto Clinico Humanitas — Milano, Lombardia, Italy (Recruiting)
Study contacts
- Study coordinator: Caterina Fossi, Ph.D
- Email: cfossi@aboca.it
- Phone: +39 3351894461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.