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.
Brief Summary

This open-label study investigates the effects of lecithin-based formulations of Curcumalonga (Meriva™) and Boswellia serrata (Casperome™) extracts on post-acute COVID-19irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without priorCOVID-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, abdominalpain, enteral dysbiosis, and global assessment of efficacy. The study found significantreductions in bloating and pain in both groups, with a notable decrease in dysbiosis onlyin the IBS group. This suggests potential benefits of the supplementation in managinggastrointestinal 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.

Completed
Post-acute COVID-19 Syndrome
Irritable Bowel Syndrome
Abdominal Pain
Dysbiosis

Dietary Supplement: Curcuma longa and Boswellia serrata extracts

Participants received 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts
(Meriva™ and Casperome™) twice daily for 30 days.

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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Italy
Locations

Mariangela Rondanelli
Pavia 3171366, PV, Italy

Giacosa Attilio, Principal Investigator
Italian Diagnostic Center (CDI)

Azienda di Servizi alla Persona di Pavia
NCT Number
Keywords
abdominal pain
Bloating
Boswellia serrata
COVID-19 infection
Curcuma longa
Dysbiosis
IBS (irritable bowel syndrome)
long COVID
MeSH Terms
Post-Acute COVID-19 Syndrome
Irritable Bowel Syndrome
Abdominal Pain
Dysbiosis
COVID-19
Turmeric extract