Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and o… (NCT06407609) | Clinical Trial Compass
CompletedNot Applicable
Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS
Italy64 participantsStarted 2022-09-03
Plain-language summary
Small bowel dysbiosis (SBD), is a frequent finding in subjects with irritable bowel syndrome (IBS). The formula-tion in sunflower lecithin (Phytosome) of Curcuma longa and Boswellia serrata demonstrated beneficial effects on intestinal microbiota. The aim of this study was to evaluate the effect of a lecithin-based delivery formulation of Curcuma longa and of Boswellia serrata extracts (CUBO), on SBD in IBS subjects.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age ranging from 18 to 70 years;
* diagnosis of moderate IBS according to Rome IV criteria;
* dysbiosis of the small bowel, defined by increased urinary indican values with normal values of urinary skatole;
* evidence of abdominal bloating and abdominal pain
Exclusion Criteria:
* normal values of urinary indican or increased values of urinary skatole ;
* subjects who were already on a low FODMAP diet (LFD) or other dietary prescription, such as lactose or gluten free diet in the last 6 months;
* insulin-dependent diabetes or seafood, nuts or soy allergies ;
* positive history of symptomatic diverticular disease, celiac disease, inflammatory bowel disease or microscopic colitis;
* colonic or small bowel or gallbladder surgery ;
* severe vomiting or bloody diarrhea ;
* liver disease (defined as altered values of liver function tests) or severe renal disease (defined as serum creatinine \>1.5 mg/dL) or treatment with antibiotics, excluding those for topical use, within the last three months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the effect of Lecithin formulation on small bowel dysbiosis