Evaluation of Dietary Supplementation in Patients With Gastrointestinal Disorders.

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how dietary supplements, specifically prebiotics and probiotics, might help patients with gastrointestinal disorders like Irritable Bowel Syndrome (IBS) and metabolic syndrome. IBS is a condition that causes chronic stomach pain and changes in bowel habits, often linked to inflammation in the gut. Researchers believe that by improving the balance of good bacteria in the gut, these supplements could help manage symptoms and reduce inflammation.

To be eligible for this trial, participants need to meet specific criteria for IBS, such as having recurring abdominal pain at least once a week and experiencing changes in their bowel habits. They also need to have at least two characteristics of metabolic syndrome, which could include issues like high blood pressure or obesity. The trial is not yet recruiting participants, but those who join can expect to contribute to research that may lead to better treatments for these common and challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * At least two criteria required for the diagnosis of IBS, according to Rome IV criteria (Lacy et al., 2021), namely:
• * presence of recurrent abdominal pain on an average of at least 1 day per week in the past 3 months, associated with two (or more) of the following criteria:
• • Related to defecation;
• • Associated with a change in stool frequency;
• • Associated with a change in stool shape/appearance.
• * At least two criteria required for the diagnosis of metabolic syndrome, namely:
• • impaired blood glucose/insulin resistance;
• • Central obesity, waist/hip ratio \> 0.9 in males; \> 0.85 in females; and/or Body Mass Index (BMI) \>30;
• • blood pressure ≥ 160/90 or taking antihypertensive drugs;
• • HDL cholesterol \< 35 mg/dl in males; \< 39 mg/dl in females;
• • triglycerides ≥ 150 mg/dl;
• • microalbuminuria \> 20μg/min or albumin/creatinine ratio \> 20mg/g (presence of trace amounts of albumin in urine.
• Exclusion Criteria:
• • Hypersensitivity to one or more ingredients;
• • Diagnosis of metabolic syndrome;
• • Prior history of stroke and/or myocardial infarction;
• • Presence of altered mood;
• • Presence of kidney or intestinal disease, pancreatitis, diabetes, or any other endocrine disorder;
• • Presence of demyelinating and dysmyelinating diseases;
• • Inability to provide informed consent.