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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06407609
• Other study ID #: 0612/22052019
• Status: Completed
• Phase: N/A
• Start date: September 3, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: May 2024
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• Curcuma and boswellia extracts plus low fodmap diet
Low Foodmap diet + Curcuma and boswellia extracts both formulated in sunflower lecithin (Phytosome™) and processed with a strong commitment to sustainability

Other:
• Low Foodmap diet
such as lactose or gluten free diet in the last 6 months

Locations

Country	Name	City	State
Italy	Mariangela Rondanelli	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effect of Lecithin formulation on small bowel dysbiosis	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.	from baseline to 30 days