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

A

Azienda di Servizi alla Persona di Pavia

Status

Completed

Conditions

Irritable Bowel Syndrome
Boswellia Serrata

Treatments

Dietary Supplement: Curcuma and boswellia extracts plus low fodmap diet
Other: Low Foodmap diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06407609
0612/22052019

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups

CUBO and low FODMAP diet (Intervention)
Active Comparator group
Description:
Curcuma and Boswellia serrata extract plus a Low Fodmap Diet
Treatment:
Dietary Supplement: Curcuma and boswellia extracts plus low fodmap diet
LFD (Control)
Other group
Description:
Only Low Fodmap Diet
Treatment:
Other: Low Foodmap diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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