Boswellia Serrata, Irritable Bowel Syndrome
Conditions
Keywords
Bloating, Dysbiosis, Boswellia serrata, Curcuma longa, Irritable bowel syndrome, Microbiota, Phytosome
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.
Interventions
DIETARY_SUPPLEMENTCurcuma 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
OTHERLow Foodmap diet
such as lactose or gluten free diet in the last 6 months
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed