Irritable Bowel SyndromeNCT04340661
Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients
A study testing BIOintestil in people with Irritable Bowel Syndrome, run by Targeting Gut Disease S.R.L. at 1 site in Italy.
Trial summary
The aim of this double blind placebo-controlled study is to evaluate the effect of BIOintestil on fecal microbiota, inflammatory chemokines and symptoms in patients affected by Irritable Bowel Syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- BIOintestil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 5 Dec 2018to 31 Jan 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willing of sign written informed consent;
- participants affected with Irritable bowel syndrome (IBS) who satisfy Rome III criterias for diagnosis
- body weight between 48 and 104 kg, with a BMI less than 27
- age between 18 and 65 years old
Who cannot join
- participants that have not taken following medications within 30 days before randomization: steroidal anti-inflammatory drugs, antibiotics or supplemntes or functional foods that may contain probiotics or prebiotics
- women who suspect to be/are pregnant or in lactacy
- participants with Inflammatory bowel disease disgnosis or celiac disease or severe systemic disease
- participants who are intolerant to lactose or with food allergies confirmed
- particpiants with confirmed or suspected hypersensibility to one or more of Bionocol® components
- participants with severe concomitants disease that, by investigator's opinion, interfere with study partecipation
Show all 9Show fewer
- participants under anticoagulant therapy or with coagulation disease
- participants with renal and hepatic failure
- participants who have taken any investigational drug within 2 month the randomization visit
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this double blind placebo-controlled study is to evaluate the effect of BIOintestil on fecal microbiota, inflammatory chemokines and symptoms in patients affected by Irritable Bowel Syndrome (IBS).
Read the detailed description
BIOintestil is a dietary supplement based on Palmrose oil (Cymbopogon martinii) and ginger ryzoma powder. Palmrose oil effects were already established in animal model of colitis and in a pilot study on patients with IBS. In this study, 108 patients will be randomized to receive BIOintestil or placebo in a 1:1 ratio, for four weeks. Fecal and blood samples will be collected at each visit for microbiota and chemokine analysis, patients syntoms will be evaluated by administration of the validated IBS-VAS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- BIOintestil, PLACEBO
- Keywords
- Microbiota, immune system
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOintestilDietary supplement
Also called BIONOCOL
Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)
PLACEBODietary supplement
Cornstarch
| Study group | Role | What they receive |
|---|---|---|
| Bionocol arm | Experimental | Not described Receives: Dietary Supplement: BIOintestil |
| Placebo arm | Placebo comparator | Not described Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fecal Microbiota composition
relative abundance of bacteroidetes
Measured: 4 weeks
Secondary outcomes (2)
Changes in circulating cytokines and chemokines
IL-1β, IL-4, IL-6, IL-10,IL-17A,IL-17F, IL-21, IL-22, IL-23, IL-25, IL31, IL-33, IFN-γ, MIP-1b , MCP-1 cytokines and chemokines will be evaluated
Measured: 4 weeks
Irritable Bowel Syndrome-Visual Analogue Scale (IBS-VAS) score improvement
Irritable Bowel Syndrome-Visual Analogue Scale is designed to measure the treatment response of symptoms and well-being in patients suffering from IBS. It is composed by 4 items:
- abdominal pain, 2) Abnominal bloating, 3) Satisfaction of the intestinal habits 4) influence on daily life. The patients are asked to record in the VAS-IBS the overall severity of each of the 4 items on a 100-mm-long horizontal line ("very severe discomfort 0" to "no discomfort at all 100").
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start5 Dec 2018
- Primary completion30 Sep 2020
- Study completion31 Jan 2021
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targeting Gut Disease S.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando Rizzello, MD, Principal investigator, A.O.U Policlinico S.Orsola-Malpighi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340661
- Sponsor's protocol ID
- TGD-01
- Status last verified
- Apr 2020
- First submitted
- 3 Sep 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients
- ClinicalTrials.gov ID
- NCT04340661
- Acronym / sponsor ID
- TGD-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Microbiota, immune system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Targeting Gut Disease S.R.L.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 9 Apr 2020 (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.
The aim of this double blind placebo-controlled study is to evaluate the effect of BIOintestil on fecal microbiota, inflammatory chemokines and symptoms in patients affected by Irritable Bowel Syndrome (IBS).
Detailed description
BIOintestil is a dietary supplement based on Palmrose oil (Cymbopogon martinii) and ginger ryzoma powder. Palmrose oil effects were already established in animal model of colitis and in a pilot study on patients with IBS. In this study, 108 patients will be randomized to receive BIOintestil or placebo in a 1:1 ratio, for four weeks. Fecal and blood samples will be collected at each visit for microbiota and chemokine analysis, patients syntoms will be evaluated by administration of the validated IBS-VAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bionocol arm | Experimental | Dietary Supplement: BIOintestil |
| Placebo arm | Placebo comparator | Dietary Supplement: PLACEBO |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- willing of sign written informed consent;
- participants affected with Irritable bowel syndrome (IBS) who satisfy Rome III criterias for diagnosis
- body weight between 48 and 104 kg, with a BMI less than 27
- age between 18 and 65 years old
Key exclusion criteria (9 listed)
- participants that have not taken following medications within 30 days before randomization: steroidal anti-inflammatory drugs, antibiotics or supplemntes or functional foods that may contain probiotics or prebiotics
- women who suspect to be/are pregnant or in lactacy
- participants with Inflammatory bowel disease disgnosis or celiac disease or severe systemic disease
- participants who are intolerant to lactose or with food allergies confirmed
- particpiants with confirmed or suspected hypersensibility to one or more of Bionocol® components
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 |
|---|---|---|
| BIOintestilAlso: BIONOCOLGinger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii) | Dietary supplement | Bionocol arm |
| PLACEBOCornstarch | Dietary supplement | Placebo arm |
Primary outcome
Changes in fecal Microbiota composition
Time frame: 4 weeks
relative abundance of bacteroidetes
2 secondary outcomes
Changes in circulating cytokines and chemokines
Time frame: 4 weeks
Irritable Bowel Syndrome-Visual Analogue Scale (IBS-VAS) score improvement
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- 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.
Fernando Rizzello, MD principal investigator
A.O.U Policlinico S.Orsola-Malpighi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOintestil in people with Irritable Bowel Syndrome, run by Targeting Gut Disease S.R.L. 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 9 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: stopped early, as of the sponsor's last update on 18 Apr 2023. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
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?
Changes in fecal Microbiota composition (time frame: 4 weeks). 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 18 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.