Evaluation of Quality of Life in a Cohort of Diarrhoeic Irritable Bowel Syndrome (IBS-D) Patients Assuming GABA.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study aims to evaluate the impact on quality of life and abdominal discomfort of GABA and Melissa food supplement administration in patients with diarrhea-predominant irritable bowel syndrome.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age \> 18 years and ≤ 75

• A positive diagnosis of IBS-D according to Rome IV criteria.

• Both males and females.

• Negative relevant additional screening or consultation whenever appropriate

• Colonoscopy if there are alarm symptoms (eg. Rectal bleeding, pseudodiarrhea). If the patients' age is \> or = 50 yrs a colonoscopy within 5 years is mandatory.

• Availability to participate in the clinical study, confirmed by the signed informed consent form.

• Ability to conform to the study protocol.

• Patients' ability to complain study protocol procedures.

• Subjects who decide to use single or double contraceptive methods not to conceive during study period.

Locations
Other Locations
Italy
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
University of Pisa
RECRUITING
Pisa
Contact Information
Primary
Massimo Bellini, Professor
massimo.bellini@unipi.it
+39 050997415
Backup
Christian Lambiase, MD
christian.lambiase@phd.unipi.it
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
Experimental: Group A
Experimental: Group B
Related Therapeutic Areas
Sponsors
Collaborators: Azienda Ospedaliero-Universitaria Pisana (AOUP)
Leads: University of Pisa

This content was sourced from clinicaltrials.gov

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