Irritable Bowel SyndromeNCT06123234
Randomised Double-blind Active vs. Placebo Clinical Trial on the Effect of a Food Supplement on IBS in Children
A study testing Verum in people with Irritable Bowel Syndrome, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
Trial summary
The goal of this clinical trial is to test a food supplement in children of 3-17 years with IBS. The main questions it aims to answer are: Is the tested supplement able to improve and/or reduce IBS-related symptoms? After administration of the food supplement, how does the state of intestinal inflammation improve? Is… Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Verum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2023to 1 Apr 2025
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects presenting symptoms of IBS according to Rome IV criteria.
- Presence of functional disorders according to assessment questionnaire with a score of 2 or more.
- Age between 3 and 17 years and 11 months.
- Willingness of the subject/parent to participate in the study.
- Willingness of the subject/parent to complete the questionnaire.
- Willingness of subject/parent to use only the product to be tested during the duration of the study.
- Willingness of the subject/parent not to use similar products during the duration of the study.
- Parent's signature of informed consent.
Who cannot join
- Subjects who do not meet the inclusion criteria.
- Subjects considered unfit by the referring physician.
- Subjects with suspected or confirmed sensitivity to one or more components of the product.
- Subjects with psychiatric comorbidities.
- Subjects with serious illnesses.
- Subjects with differential diagnoses (functional dyspepsia, coeliac disease, IBD, food intolerances, individual hypersensitivities).
Show all 11Show fewer
- Subjects undergoing ongoing pharmacological treatment, inherent to the disease (e.g. spasmolytics etc.).
- Subjects who have recently (two weeks or less) undergone antibiotic therapy
- Subjects with other concomitant diseases (immune, infectious, respiratory or gastro-intestinal).
- Subjects with growth restriction.
- Subjects with congenital malformations.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gioacchino Calapai
Messina, 98125
Gioacchino Calapai, MD, 0902213646, gcalapai@unime.it
Carmen Mannucci, BSc, 0902212697, cmannucci@unime.it
About this study
Official title: Randomised Double-blind Active vs. Placebo Clinical Trial on the Effect of the Food Effect of the Food Supplement Enterokind® Junior on Irritable Bowel Syndrome (IBS) in Children
The goal of this clinical trial is to test a food supplement in children of 3-17 years with IBS. The main questions it aims to answer are:
- Is the tested supplement able to improve and/or reduce IBS-related symptoms?
- After administration of the food supplement, how does the state of intestinal inflammation improve?
- Is the gut microbiota modified?
Read more
Participants will take the food supplement every day for 2 months. After 30 days and after 60 days, they will be visited from the gastroenterologist.
- They have to fill in the questionnaire and the symptom's diary weekly and deliver it to the gastroenterologist during the visits
- At the first visit, they will collect the faecal sample for the analysis of inflammatory markers and gut microbiota
- After 30 days, they will collect the faecal sample for the analysis of inflammatory markers
- After 60 days, they will collect the faecal sample for the analysis of gut microbiota Researchers will compare with placebo to see if the product is effective.
Read the detailed description
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder characterised essentially by abdominal pain and alterations in bowel movements. IBS is linked to a sensory and intestinal motor dysfunction, to the genesis, clinical presentation and evolution of which both medical factors (e.g. infection, inflammation, trauma, etc.) and psychosocial factors (stress, anxiety, depression, abuse, etc.) contribute. In recent decades, the prevalence of IBS, which is common in adults, has also increased in paediatric patients with rates ranging from 7 to 21%.
Due to the persistence, recurrence and intensity of pain and bowel disorders, IBS has a significant impact on patients' daily activities and quality of life. Due to the multifactorial nature of the disorder, the treatment of IBS is not simple. Supplementation with probiotic bacteria can help restore the correct state of intestinal eubiosis by repopulating the microbiota with those bacterial species that are deficient in IBS sufferers.
The formula of the product to be tested in this study contains L. acidophilus and L. reuteri and is supplemented with a dry extract of chamomile titrated in apigenin, vitamin A and vitamin D3. The product under study, therefore, is specially formulated with active ingredients and components that, based on the available literature and scientific data, can reasonably be expected to help improve intestinal inflammatory conditions and play a therapeutic role in IBS.
The aim of the study is to evaluate the effect of the dietary supplement on IBS diagnosed according to Rome IV criteria in children in the age group 3-17 years. The main objective (primary end-point) will be to evaluate the short (30 days) and medium (60 days) term effects of the product. For this purpose, a scoring questionnaire (SGARC-Subject's Global Assessment of Relief for Children) will be administered to assess relief with respect to these symptoms. All subjects who have a decrease of at least 1 point in their questionnaire score compared to the beginning of the study will be considered as "Responders". Taking into account a probable 40% Responder in the control group due to the placebo effect, the expected benefit in the active group is an improvement, compared to the initial condition, in at least 70% of the subjects (30% more Responder than placebo). As a secondary end-point, the reduction of the most common symptoms related to IBS (abdominal pain and bloating, stool characteristics, etc.) will also be assessed by means of a scoring questionnaire. Further secondary end-points will be the evaluation of the influence of the product on both the inflammatory state and the intestinal microbial populations (microbiota).
Patients will be divided into 2 groups of 50 subjects each, who will be given alternately, according to a randomisation list, the study product containing probiotics, chamomile extract and vitamins A and D3, and a placebo product, containing excipients, for 60 days. The study involves an initial visit with the referring doctor during which recruitment will take place, followed by two further visits, one after 30 and one after 60 days of taking the product.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Verum, Placebo
- 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.
VerumDietary supplement
Food supplement in single-dose vials
PlaceboOther
Food supplement in single-dose vials
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Partecipants received a food supplement with probiotics, chamomile, vitamin A, vitamin D in single-dose vials every day for 60 days. Receives: Dietary Supplement: Verum |
| Placebo | Placebo comparator | Placebo does not contain any active ingredients. Partecipants received placebo in single-dose vials every day for 60 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the relief of IBS related symptoms
Evaluation of the relief of IBS related symptoms by means of a questionnaire to be completed during visits, which follows SGARC (Subject's Global Assessment Relief for Children) validated 5-points scale (from 0 to 4, where 0 = complete relief and 4 = worsening).
Measured: T0 (first visit - day 0), T30 days, T60 days
Evaluation of the reduction of IBS related symptoms
Evaluation of the reduction of IBS related symptoms by means of a 2-questions questionnaire to be completed during visits
Measured: T0 (first visit - day 0), T30 days, T60 days
Secondary outcomes (2)
Variation of inflammatory markers and of the gut microbiota
variation of faecal inflammatory markers calprotectin, TNFα and zonulin; effect of the product on modulation of the gut microbiota assessed by metagenomics analysis.
Measured: T0 (first visit - day 0), T30 days
Metagenomic analysis of the gut microbiota
Metagenomic analysis of the gut microbiota: DNA extraction, amplification and sequencing of 16S r-DNA and subsequent analysis by Next Generation Sequencing (NGS)
Measured: T0 (first visit - day 0), T 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
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
- Model description
- Randomized double blind verum vs placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123234
- Sponsor's protocol ID
- ENTJR
- Status last verified
- Nov 2023
- First submitted
- 19 Jun 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double-blind Active vs. Placebo Clinical Trial on the Effect of the Food Effect of the Food Supplement Enterokind® Junior on Irritable Bowel Syndrome (IBS) in Children
- ClinicalTrials.gov ID
- NCT06123234
- Acronym / sponsor ID
- ENTJR
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 8 Nov 2023 (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 goal of this clinical trial is to test a food supplement in children of 3-17 years with IBS. The main questions it aims to answer are:
- Is the tested supplement able to improve and/or reduce IBS-related symptoms?
- After administration of the food supplement, how does the state of intestinal inflammation improve?
- Is the gut microbiota modified?
Participants will take the food supplement every day for 2 months. After 30 days and after 60 days, they will be visited from the gastroenterologist.
- They have to fill in the questionnaire and the symptom's diary weekly and deliver it to the gastroenterologist during the visits
- At the first visit, they will collect the faecal sample for the analysis of inflammatory markers and gut microbiota
- After 30 days, they will collect the faecal sample for the analysis of inflammatory markers
- After 60 days, they will collect the faecal sample for the analysis of gut microbiota Researchers will compare with placebo to see if the product is effective.
Detailed description
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder characterised essentially by abdominal pain and alterations in bowel movements. IBS is linked to a sensory and intestinal motor dysfunction, to the genesis, clinical presentation and evolution of which both medical factors (e.g. infection, inflammation, trauma, etc.) and psychosocial factors (stress, anxiety, depression, abuse, etc.) contribute. In recent decades, the prevalence of IBS, which is common in adults, has also increased in paediatric patients with rates ranging from 7 to 21%.
Due to the persistence, recurrence and intensity of pain and bowel disorders, IBS has a significant impact on patients' daily activities and quality of life. Due to the multifactorial nature of the disorder, the treatment of IBS is not simple. Supplementation with probiotic bacteria can help restore the correct state of intestinal eubiosis by repopulating the microbiota with those bacterial species that are deficient in IBS sufferers.
The formula of the product to be tested in this study contains L. acidophilus and L. reuteri and is supplemented with a dry extract of chamomile titrated in apigenin, vitamin A and vitamin D3. The product under study, therefore, is specially formulated with active ingredients and components that, based on the available literature and scientific data, can reasonably be expected to help improve intestinal inflammatory conditions and play a therapeutic role in IBS.
The aim of the study is to evaluate the effect of the dietary supplement on IBS diagnosed according to Rome IV criteria in children in the age group 3-17 years. The main objective (primary end-point) will be to evaluate the short (30 days) and medium (60 days) term effects of the product. For this purpose, a scoring questionnaire (SGARC-Subject's Global Assessment of Relief for Children) will be administered to assess relief with respect to these symptoms. All subjects who have a decrease of at least 1 point in their questionnaire score compared to the beginning of the study will be considered as "Responders". Taking into account a probable 40% Responder in the control group due to the placebo effect, the expected benefit in the active group is an improvement, compared to the initial condition, in at least 70% of the subjects (30% more Responder than placebo). As a secondary end-point, the reduction of the most common symptoms related to IBS (abdominal pain and bloating, stool characteristics, etc.) will also be assessed by means of a scoring questionnaire. Further secondary end-points will be the evaluation of the influence of the product on both the inflammatory state and the intestinal microbial populations (microbiota).
Patients will be divided into 2 groups of 50 subjects each, who will be given alternately, according to a randomisation list, the study product containing probiotics, chamomile extract and vitamins A and D3, and a placebo product, containing excipients, for 60 days. The study involves an initial visit with the referring doctor during which recruitment will take place, followed by two further visits, one after 30 and one after 60 days of taking the product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blind verum vs placebo
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Dietary Supplement: VerumPartecipants received a food supplement with probiotics, chamomile, vitamin A, vitamin D in single-dose vials every day for 60 days. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo does not contain any active ingredients. Partecipants received placebo in single-dose vials every day for 60 days. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subjects presenting symptoms of IBS according to Rome IV criteria.
- Presence of functional disorders according to assessment questionnaire with a score of 2 or more.
- Age between 3 and 17 years and 11 months.
- Willingness of the subject/parent to participate in the study.
- Willingness of the subject/parent to complete the questionnaire.
Key exclusion criteria (11 listed)
- Subjects who do not meet the inclusion criteria.
- Subjects considered unfit by the referring physician.
- Subjects with suspected or confirmed sensitivity to one or more components of the product.
- Subjects with psychiatric comorbidities.
- Subjects with serious illnesses.
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 |
|---|---|---|
| VerumFood supplement in single-dose vials | Dietary supplement | Verum |
| PlaceboFood supplement in single-dose vials | Other | Placebo |
Primary outcome
Evaluation of the relief of IBS related symptoms
Time frame: T0 (first visit - day 0), T30 days, T60 days
Evaluation of the relief of IBS related symptoms by means of a questionnaire to be completed during visits, which follows SGARC (Subject's Global Assessment Relief for Children) validated 5-points scale (from 0 to 4, where 0 = complete relief and 4 = worsening).
Evaluation of the reduction of IBS related symptoms
Time frame: T0 (first visit - day 0), T30 days, T60 days
Evaluation of the reduction of IBS related symptoms by means of a 2-questions questionnaire to be completed during visits
2 secondary outcomes
Variation of inflammatory markers and of the gut microbiota
Time frame: T0 (first visit - day 0), T30 days
Metagenomic analysis of the gut microbiota
Time frame: T0 (first visit - day 0), T 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum in people with Irritable Bowel Syndrome, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" 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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Jul 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio Romano, Associate Professor (+39 090 2213818, claudio.romano@unime.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the relief of IBS related symptoms (time frame: T0 (first visit - day 0), T30 days, T60 days). The study lists 2 primary outcomes in all. 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 16 Jul 2024.