Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS (NCT06423586) | Clinical Trial Compass
CompletedNot Applicable
Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS
Italy44 participantsStarted 2021-09-01
Plain-language summary
This open-label study investigates the effects of lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts on post-acute COVID-19 irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without prior COVID-19 infection. A total of 44 participants, 16 with PCIBS and 28 controls with IBS, were supplemented for 30 days. Outcomes measured included abdominal bloating, abdominal pain, enteral dysbiosis, and global assessment of efficacy. The study found significant reductions in bloating and pain in both groups, with a notable decrease in dysbiosis only in the IBS group. This suggests potential benefits of the supplementation in managing gastrointestinal symptoms associated with PCIBS and IBS.
Who can participate
Age range
18 Years – 75 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: 18-75 years, male or female.
* Diagnosis of post-acute COVID-19 irritable bowel syndrome (PCIBS) 60-120 days after the end of infection.
* Diagnosis of irritable bowel syndrome (IBS) without prior COVID-19 infection.
* Evidence of functional abdominal bloating/distention (FAB/D) type of IBS according to Mearin et al.
* Presence of enteral dysbiosis defined by increased urinary indican values with normal skatole urinary concentration.
Exclusion Criteria:
* Normal urinary indican values or increased urinary skatole values.
* Subjects already on a low FODMAP diet or other dietary restrictions such as gluten-free diet or lactose-free diet within the past 6 months.
* Allergies to soy, nuts, or seafood, or insulin-dependent diabetes.
* Known history of celiac disease, symptomatic diverticular disease, inflammatory bowel disease, or microscopic colitis.
* Prior small bowel or colonic surgery or cholecystectomy.
* Presence of bloody diarrhea or severe vomiting.
* Severe renal disease (serum creatinine \>1.5 mg/dL) or liver disease (altered liver function tests).
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.