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CompletedNCT06407609Updated May 9, 2024

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

An interventional study of Curcuma and boswellia extracts plus low fodmap diet and Low Foodmap diet in Boswellia Serrata and Irritable Bowel Syndrome, sponsored by Azienda di Servizi alla Persona di Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by Azienda di Servizi alla Persona di Pavia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Sep 2022, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Boswellia Serrata
  • Irritable Bowel Syndrome

Keywords

  • Bloating
  • Dysbiosis
  • Boswellia serrata
  • Curcuma longa
  • Irritable bowel syndrome
  • Microbiota
  • Phytosome
03

In context

Irritable Bowel Syndrome

1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.

This study's enrollment of 64 is close to the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Azienda di Servizi alla Persona di Pavia is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    CUBO and low FODMAP diet (Intervention)

    Curcuma and Boswellia serrata extract plus a Low Fodmap Diet

    Dietary Supplement: Curcuma and boswellia extracts plus low fodmap diet

  • Other
    LFD (Control)

    Only Low Fodmap Diet

    Other: Low Foodmap diet

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: from baseline to 30 days

07

Study locations

1 site
  • Mariangela Rondanelli
    Pavia, PV 27100, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Mar 2023, 6 months.

Of 297 non-industry interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 6 months is below that.

Counting every sponsor, half of 345 studies reached it within 19 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 19, 2024
First posted
May 9, 2024
StartActual
Sep 3, 2022
Primary completionActual
Mar 3, 2023
CompletionActual
Mar 3, 2023
Last update
May 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06407609
Lead sponsor
Azienda di Servizi alla Persona di Pavia
Responsible party
Sponsor
First posted
May 9, 2024
Start date
Sep 3, 2022
Primary completion
Mar 3, 2023
Completion
Mar 3, 2023
Last update
May 9, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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