Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS

Not Applicable

Completed

• Conditions: Boswellia Serrata; Irritable Bowel Syndrome
• Interventions: Other: Low Foodmap diet; Dietary Supplement: Curcuma and boswellia extracts plus low fodmap diet

• Registration Number: NCT06407609
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

Brief Summary

Small bowel dysbiosis (SBD), is a frequent finding in subjects with irritable bowel syndrome (IBS). The formula-tion in sunflower lecithin (Phytosome) of Curcuma longa and Boswellia serrata demonstrated beneficial effects on intestinal microbiota. The aim of this study was to evaluate the effect of a lecithin-based delivery formulation of Curcuma longa and of Boswellia serrata extracts (CUBO), on SBD in IBS subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-03
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Study First Submitted: 2024-04-19
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• age ranging from 18 to 70 years;
• diagnosis of moderate IBS according to Rome IV criteria;
• dysbiosis of the small bowel, defined by increased urinary indican values with normal values of urinary skatole;
• evidence of abdominal bloating and abdominal pain

Exclusion Criteria

• normal values of urinary indican or increased values of urinary skatole ;
• subjects who were already on a low FODMAP diet (LFD) or other dietary prescription, such as lactose or gluten free diet in the last 6 months;
• insulin-dependent diabetes or seafood, nuts or soy allergies ;
• positive history of symptomatic diverticular disease, celiac disease, inflammatory bowel disease or microscopic colitis;
• colonic or small bowel or gallbladder surgery ;
• severe vomiting or bloody diarrhea ;
• liver disease (defined as altered values of liver function tests) or severe renal disease (defined as serum creatinine >1.5 mg/dL) or treatment with antibiotics, excluding those for topical use, within the last three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LFD (Control)	Low Foodmap diet	Only Low Fodmap Diet
CUBO and low FODMAP diet (Intervention)	Curcuma and boswellia extracts plus low fodmap diet	Curcuma and Boswellia serrata extract plus a Low Fodmap Diet

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of Lecithin formulation on small bowel dysbiosis	from baseline to 30 days	The primary endpoint was the change of small bowel dysbiosis established by the decrease in urine indican values. The dysbiosis of the small bowel was defined by increased urinary indican values with normal values of urinary skatole.; Urinary values of indican (3-indoxyl sulfate) were evaluated through a colorimetric method. Urinary indican was considered normal when the levels were lower than 10 mg/L.

Trial Locations

Locations (1)

Mariangela Rondanelli; 🇮🇹 Pavia, PV, Italy