Clinical trial NCT06423586: Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS
Official title: Positive Effect of Lecithin-based Delivery Form of Curcuma and Boswellia Extracts on Post-acute COVID-19 Irritable Bowel Syndrome. Two Cohorts of an Open-label Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Irritable Bowel Syndrome
Abdominal Pain
Dysbiosis
Keywords: abdominal pain
Bloating
Boswellia serrata
Covid-19 infection
Curcuma longa
Dysbiosis
IBS (irritable bowel syndrome)
Long Covid
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study aims to evaluate the efficacy and safety of lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts in treating gastrointestinal symptoms in patients with post-acute COVID-19 irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without prior COVID-19 infection. The study was conducted at the Department of Public Health of the University of Pavia, Italy. Participants included 16 PCIBS patients and 28 IBS controls, aged 18-75 years. They were administered 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts twice daily for 30 days, in conjunction with a low FODMAP diet. Key outcomes measured were reductions in abdominal bloating and pain, changes in enteral dysbiosis as indicated by urinary indican levels, and overall treatment efficacy as assessed by participants. The study found that both groups experienced significant reductions in abdominal bloating and pain. However, a notable decrease in enteral dysbiosis was observed only in the IBS control group. The treatment was well tolerated with no reported adverse effects. These findings suggest that the combination of Curcuma longa and Boswellia serrata extracts may provide significant benefits in managing gastrointestinal symptoms associated with PCIBS and IBS.

Eligibility criteria: 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).

Primary outcomes:
measure: Reduction in Abdominal Bloating
timeFrame: 30 days
Secondary outcomes:
measure: Change in Urinary Indican Levels
timeFrame: 30 days
Other outcomes:
measure: Global Assessment of Efficacy (GAE)
timeFrame: 30 days
Locations:
city: Pavia
country: Italy
facility: Mariangela Rondanelli
state: PV
Study officials:
affiliation: Italian Diagnostic Center (CDI)
name: Giacosa Attilio
role: PRINCIPAL_INVESTIGATOR
References: