Boswellia SerrataNCT06407609
Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS
A study testing Curcuma and boswellia extracts plus low fodmap diet and Low Foodmap diet in people with Boswellia Serrata and Irritable Bowel Syndrome, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Boswellia Serrata, Irritable Bowel Syndrome
- What is being tested?
- Curcuma and boswellia extracts plus low fodmap diet and Low Foodmap diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 3 Sep 2022to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Boswellia Serrata, Irritable Bowel Syndrome
- Being tested
- Curcuma and boswellia extracts plus low fodmap diet, Low Foodmap diet
- Keywords
- Bloating, Dysbiosis, Boswellia serrata, Curcuma longa, Irritable bowel syndrome, Microbiota, Phytosome
- Medical subject headings
- Irritable Bowel Syndrome, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcuma and boswellia extracts plus low fodmap dietDietary supplement
Low Foodmap diet + Curcuma and boswellia extracts both formulated in sunflower lecithin (Phytosome™) and processed with a strong commitment to sustainability
Low Foodmap dietOther
such as lactose or gluten free diet in the last 6 months
| Study group | Role | What they receive |
|---|---|---|
| CUBO and low FODMAP diet (Intervention) | Active comparator | Curcuma and Boswellia serrata extract plus a Low Fodmap Diet Receives: Dietary Supplement: Curcuma and boswellia extracts plus low fodmap diet |
| LFD (Control) | Other | Only Low Fodmap Diet Receives: Other: Low Foodmap diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start3 Sep 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Boswellia SerrataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407609
- Sponsor's protocol ID
- 0612/22052019
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06407609
- Acronym / sponsor ID
- 0612/22052019
- Conditions
- Boswellia Serrata, Irritable Bowel Syndrome
- Keywords
- Bloating, Dysbiosis, Boswellia serrata, Curcuma longa, Irritable bowel syndrome, Microbiota, Phytosome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CUBO and low FODMAP diet (Intervention) | Active comparator | Dietary Supplement: Curcuma and boswellia extracts plus low fodmap dietCurcuma and Boswellia serrata extract plus a Low Fodmap Diet |
| LFD (Control) | Other | Other: Low Foodmap dietOnly Low Fodmap Diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcuma and boswellia extracts plus low fodmap dietLow Foodmap diet + Curcuma and boswellia extracts both formulated in sunflower lecithin (Phytosome™) and processed with a strong commitment to sustainability | Dietary supplement | CUBO and low FODMAP diet (Intervention) |
| Low Foodmap dietsuch as lactose or gluten free diet in the last 6 months | Other | LFD (Control) |
Primary outcome
Evaluate the effect of Lecithin formulation on small bowel dysbiosis
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcuma and boswellia extracts plus low fodmap diet and Low Foodmap diet in people with Boswellia Serrata and Irritable Bowel Syndrome, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of Lecithin formulation on small bowel dysbiosis (time frame: from baseline to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.