Post-Acute COVID-19 SyndromeNCT06423586
Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS
A study testing Curcuma longa and Boswellia serrata extracts in people with Post-Acute COVID-19 Syndrome and Irritable Bowel Syndrome, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial summary
This open-label study investigates the effects of lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts on post-acute COVID-19 irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without prior COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Acute COVID-19 Syndrome, Irritable Bowel Syndrome, Abdominal Pain
- What is being tested?
- Curcuma longa and Boswellia serrata extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 10 Jun 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years, male or female.
- Diagnosis of post-acute COVID-19 irritable bowel syndrome (PCIBS) 60-120 days after the end of infection.
- Diagnosis of irritable bowel syndrome (IBS) without prior COVID-19 infection.
- Evidence of functional abdominal bloating/distention (FAB/D) type of IBS according to Mearin et al.
- Presence of enteral dysbiosis defined by increased urinary indican values with normal skatole urinary concentration.
Who cannot join
- Normal urinary indican values or increased urinary skatole values.
- Subjects already on a low FODMAP diet or other dietary restrictions such as gluten-free diet or lactose-free diet within the past 6 months.
- Allergies to soy, nuts, or seafood, or insulin-dependent diabetes.
- Known history of celiac disease, symptomatic diverticular disease, inflammatory bowel disease, or microscopic colitis.
- Prior small bowel or colonic surgery or cholecystectomy.
- Presence of bloody diarrhea or severe vomiting.
- Severe renal disease (serum creatinine >1.5 mg/dL) or liver disease (altered liver function tests).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive Effect of Lecithin-based Delivery Form of Curcuma and Boswellia Extracts on Post-acute COVID-19 Irritable Bowel Syndrome. Two Cohorts of an Open-label Study.
This open-label study investigates the effects of lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts on post-acute COVID-19 irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without prior COVID-19 infection. A total of 44 participants, 16 with PCIBS and 28 controls with IBS, were supplemented for 30 days. Outcomes measured included abdominal bloating, abdominal pain, enteral dysbiosis, and global assessment of efficacy. The study found significant reductions in bloating and pain in both groups, with a notable decrease in dysbiosis only in the IBS group. This suggests potential benefits of the supplementation in managing gastrointestinal symptoms associated with PCIBS and IBS.
Read the detailed description
This study aims to evaluate the efficacy and safety of lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts in treating gastrointestinal symptoms in patients with post-acute COVID-19 irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without prior COVID-19 infection. The study was conducted at the Department of Public Health of the University of Pavia, Italy. Participants included 16 PCIBS patients and 28 IBS controls, aged 18-75 years. They were administered 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts twice daily for 30 days, in conjunction with a low FODMAP diet. Key outcomes measured were reductions in abdominal bloating and pain, changes in enteral dysbiosis as indicated by urinary indican levels, and overall treatment efficacy as assessed by participants. The study found that both groups experienced significant reductions in abdominal bloating and pain. However, a notable decrease in enteral dysbiosis was observed only in the IBS control group. The treatment was well tolerated with no reported adverse effects. These findings suggest that the combination of Curcuma longa and Boswellia serrata extracts may provide significant benefits in managing gastrointestinal symptoms associated with PCIBS and IBS.
- Being tested
- Curcuma longa and Boswellia serrata extracts
- Keywords
- abdominal pain, Bloating, Boswellia serrata, Covid-19 infection, Curcuma longa, Dysbiosis, IBS (irritable bowel syndrome), Long Covid
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Irritable Bowel Syndrome, Abdominal Pain, Dysbiosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcuma longa and Boswellia serrata extractsDietary supplement
Participants received 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts (Meriva™ and Casperome™) twice daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| PCIBS Group | Experimental | Participants with post-acute COVID-19 irritable bowel syndrome (PCIBS) supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts. Receives: Dietary Supplement: Curcuma longa and Boswellia serrata extracts |
| IBS Control Group | Active comparator | Participants with irritable bowel syndrome (IBS) without prior COVID-19 infection supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts. Receives: Dietary Supplement: Curcuma longa and Boswellia serrata extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Abdominal Bloating
Measure the change in abdominal bloating severity from baseline to the end of the study using a validated questionnaire.
Measured: 30 days
Secondary outcomes (1)
Change in Urinary Indican Levels
Evaluate the change in urinary indican levels from baseline to the end of the study to assess enteral dysbiosis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Sep 2021
- Primary completion1 Oct 2021
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giacosa Attilio, Principal investigator, Italian Diagnostic Center (CDI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423586
- Sponsor's protocol ID
- 0912/09052020
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 23 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Effect of Lecithin-based Delivery Form of Curcuma and Boswellia Extracts on Post-acute COVID-19 Irritable Bowel Syndrome. Two Cohorts of an Open-label Study.
- ClinicalTrials.gov ID
- NCT06423586
- Acronym / sponsor ID
- 0912/09052020
- Keywords
- abdominal pain, Bloating, Boswellia serrata, Covid-19 infection, Curcuma longa, Dysbiosis, IBS (irritable bowel syndrome), Long Covid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 21 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.
This open-label study investigates the effects of lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts on post-acute COVID-19 irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without prior COVID-19 infection. A total of 44 participants, 16 with PCIBS and 28 controls with IBS, were supplemented for 30 days. Outcomes measured included abdominal bloating, abdominal pain, enteral dysbiosis, and global assessment of efficacy. The study found significant reductions in bloating and pain in both groups, with a notable decrease in dysbiosis only in the IBS group. This suggests potential benefits of the supplementation in managing gastrointestinal symptoms associated with PCIBS and IBS.
Detailed description
This study aims to evaluate the efficacy and safety of lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts in treating gastrointestinal symptoms in patients with post-acute COVID-19 irritable bowel syndrome (PCIBS) and irritable bowel syndrome (IBS) without prior COVID-19 infection. The study was conducted at the Department of Public Health of the University of Pavia, Italy. Participants included 16 PCIBS patients and 28 IBS controls, aged 18-75 years. They were administered 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts twice daily for 30 days, in conjunction with a low FODMAP diet. Key outcomes measured were reductions in abdominal bloating and pain, changes in enteral dysbiosis as indicated by urinary indican levels, and overall treatment efficacy as assessed by participants. The study found that both groups experienced significant reductions in abdominal bloating and pain. However, a notable decrease in enteral dysbiosis was observed only in the IBS control group. The treatment was well tolerated with no reported adverse effects. These findings suggest that the combination of Curcuma longa and Boswellia serrata extracts may provide significant benefits in managing gastrointestinal symptoms associated with PCIBS and IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCIBS Group | Experimental | Dietary Supplement: Curcuma longa and Boswellia serrata extractsParticipants with post-acute COVID-19 irritable bowel syndrome (PCIBS) supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts. |
| IBS Control Group | Active comparator | Dietary Supplement: Curcuma longa and Boswellia serrata extractsParticipants with irritable bowel syndrome (IBS) without prior COVID-19 infection supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-75 years, male or female.
- Diagnosis of post-acute COVID-19 irritable bowel syndrome (PCIBS) 60-120 days after the end of infection.
- Diagnosis of irritable bowel syndrome (IBS) without prior COVID-19 infection.
- Evidence of functional abdominal bloating/distention (FAB/D) type of IBS according to Mearin et al.
- Presence of enteral dysbiosis defined by increased urinary indican values with normal skatole urinary concentration.
Key exclusion criteria (7 listed)
- Normal urinary indican values or increased urinary skatole values.
- Subjects already on a low FODMAP diet or other dietary restrictions such as gluten-free diet or lactose-free diet within the past 6 months.
- Allergies to soy, nuts, or seafood, or insulin-dependent diabetes.
- Known history of celiac disease, symptomatic diverticular disease, inflammatory bowel disease, or microscopic colitis.
- Prior small bowel or colonic surgery or cholecystectomy.
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 longa and Boswellia serrata extractsParticipants received 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts (Meriva™ and Casperome™) twice daily for 30 days. | Dietary supplement | IBS Control Group, PCIBS Group |
Primary outcome
Reduction in Abdominal Bloating
Time frame: 30 days
Measure the change in abdominal bloating severity from baseline to the end of the study using a validated questionnaire.
1 secondary outcome
Change in Urinary Indican Levels
Time frame: 30 days
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 23 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.
Giacosa Attilio principal investigator
Italian Diagnostic Center (CDI)
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 longa and Boswellia serrata extracts in people with Post-Acute COVID-19 Syndrome 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 5 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 23 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?
Reduction in Abdominal Bloating (time frame: 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 23 May 2024.