Digestive System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age: Patients aged 18 to 64 years. Confirmed diagnosis: IBS diagnosed according to the Rome IV criteria, after exclusion of any organic disease. Digestive symptoms: Presence of digestive symptoms persisting for at least 6 months before diagnosis, including abdominal pain, bloating, and altered bowel habits. Informed consent: Ability to provide informed consent to participate in the study, understanding of the study objectives, and willingness to comply with the study schedule (visits, questionnaires, and treatment intake).
Exclusion criteria
Exclusion criteria: Other gastrointestinal disorders: Presence of an active or known organic gastrointestinal disease, including inflammatory bowel disease (Crohn's disease, ulcerative colitis), celiac disease, digestive cancer, or a history of major intestinal resection. Unexplored alarm symptoms: Rectal bleeding, significant unintentional weight loss, or unexplained anemia. Severe uncontrolled comorbidities: Severe heart failure, end-stage renal disease, or decompensated liver disease. Use of other supplements or medications: Recent use of medications affecting intestinal motility or the gut microbiota, or of other supplements that could interfere with the study results, such as probiotics. Pregnancy or breastfeeding. Psychiatric or cognitive disorders: Severe, unstabilized disorders affecting the patient's ability to complete questionnaires or follow study instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IBS symptom severity from baseline to one month, assessed using the [IBS Symptom Severity Scale (IBS-SSS)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life from baseline to one month, assessed using the [IBS Quality of Life questionnaire (IBS-QoL)]. | — |
Countries
Tunisia
Contacts
Higher School of Health Sciences and Techniques of Tunis