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OpenTrials
Completed

NCT Number: NCT06423586

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Reduction in Abdominal Bloating

    Time frame: 30 days

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

Secondary outcomes

  1. Change in Urinary Indican Levels

    Time frame: 30 days

    Evaluate the change in urinary indican levels from baseline to the end of the study to assess enteral dysbiosis

Other outcomes

  1. Global Assessment of Efficacy (GAE)

    Time frame: 30 days

    Assess the overall efficacy of the treatment using a 4-point scale (ineffective, moderately effective, effective, very effective).

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 21, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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