Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS

NCT06423586 | Completed

• 1 other identifier: 0912/09052020
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Reduction in Abdominal Bloating

  Measure the change in abdominal bloating severity from baseline to the end of the study using a validated questionnaire.

  30 days

Secondary Outcomes (1)

• Change in Urinary Indican Levels

  30 days

Other Outcomes (1)

• Global Assessment of Efficacy (GAE)

  30 days

Study Arms (2)

PCIBS Group

EXPERIMENTAL

Participants with post-acute COVID-19 irritable bowel syndrome (PCIBS) supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts.

Dietary Supplement: Curcuma longa and Boswellia serrata extracts

IBS Control Group

ACTIVE COMPARATOR

Participants with irritable bowel syndrome (IBS) without prior COVID-19 infection supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts.

Dietary Supplement: Curcuma longa and Boswellia serrata extracts

Interventions

Curcuma longa and Boswellia serrata extracts DIETARY_SUPPLEMENT

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

IBS Control Group; PCIBS Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

Study Sites (1)

Mariangela Rondanelli

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Irritable Bowel Syndrome; Abdominal Pain; Dysbiosis; COVID-19

Interventions

turmeric extract

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Giacosa Attilio

  Italian Diagnostic Center (CDI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: September 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: June 10, 2022
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)