Bifidobacterium Adolescentis PRL2019NCT05737277
Gabapral in Pediatric IBS
A study testing Gabapral in people with Bifidobacterium Adolescentis PRL2019 and IBS, run by Azienda Ospedaliera "Sant'Andrea".
Trial summary
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder (FGID) characterized by recurrent episodes of defecation related abdominal pain associated with abnormal bowel habit. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Bifidobacterium Adolescentis PRL2019, IBS, Pediatric
- What is being tested?
- Gabapral
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Jul 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IBS subtypes 4 -17 years of age,
- negative fecal calprotectine
- negative anti-transglutaminasi antibodies.
Who cannot join
- the current use of nonsteroidal anti-inflammatory drugs, corticosteroids and mast cell stabilisers,
- the use of topical or systemic antibiotics in the last month,
- use of stimulant laxatives,
- major abdominal surgery,
- inflammatory bowel disease,
- infectious diarrhoea,
- allergic diseases a
- psychiatric disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bifidobacterium Adolescentis PRL2019 in Pediatric Irritable Bowel Siyndrome: a Randomized Controlled Trial
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder (FGID) characterized by recurrent episodes of defecation related abdominal pain associated with abnormal bowel habit. Several studies have reported significant alterations in the gut microbiota that may promote the development and persistence of IBS. Some Bifidobacterium species, mainly Bifidobacterium adolescentis, have a documented immunomodulatory effect and can modulate visceral hypersensitivity or improve the integrity of the intestinal epithelium barrier thorough its well-known ability to produce g-aminobutyric acid
Thus, designed a randomised, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of Bifidobacterium adolescentis PRL2019 on abdominal pain symptoms in pediatric patients with Irritative bowel sindorom
Read the detailed description
This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to evaluate the efficacy and safety of Bifidobacterium adolescentis PRL2019 in pediatric patients (> 4 years) with Irritative bpwel sindrome (as assessed according to the Rome IV diagnostic criteria for IBS).
The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period. After the screening phase, eligible patients will be randomly assigned to either 1 stick containing 20 Mld UFC of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy), or the equivalent placebo (without the active treatment, once a day, in a 1:1 ratio, for 12 weeks. Study visits will be conducted every 4 weeks during the treatment period. All the subjects will be blindly allocated by means of scratch cards to one of the two treatment groups according to a computer-generated randomisation list provided by our statistician. A validated program will be used by an independent statistician to generate a randomisation list with blocks, block size = 4, pre-allocated to centres. Patients and study investigators will be blinded to the randomisation codes. The codes will be kept confidential until the end of the study when the randomisation code will be broken after the database lock.
All subjects will undergo a formal clinical assessment and will be further phenotyped using validated questionnaires. Number of bowel movements per day and/or week and bowel habit characteristics, will be assessed by the Bristol stool scale.
The protocol will be approved by an independent ethics committee and conducted according to the Declaration of Helsinki and the principles of good clinical practice. The trial will be registered in a public registry.
The primary outcome will be the change in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period. Secondary outcomes will be modifications of bowel habits and safety.
Study patients
Eligible patients with symptoms meeting Rome IV criteria for diagnosis of Irritative bowel sindrome will be recruited from Sant'Andrea University Hospital.
Inclusion criteria will comprise a positive diagnosis of all Irritative Bowel Sindrome subtypes, at least 4 and no more of 17 years of age, negative fecal calprotectine and anti-transglutaminasi antibodies.
Exclusion criteria will include the current use of nonsteroidal anti-inflammatory drugs, corticosteroids and mast cell stabilisers, the use of topical or systemic antibiotics in the last month, or the continuous use of stimulant laxatives, major abdominal surgery, inflammatory bowel disease, infectious diarrhoea, allergic diseases and other organic or psychiatric disorders.
Statistical Analysis
The estimated total sample size that was aimed was 96 (48 children per arm) with the power of 80% (alpha of 5%). We estimated a dropout rate of 20% and aimed to recruit 120 participants to provide at least 96 evaluable assessments.
Difference between continuous variables will be assessed either by two-tailed Student t test for values with normal distribution or the MannWhitney test for non-normally distributed variables.
paired samples, based on distribution, Student t test for paired samples or Wilcoxon test will be used. To compare categorical variables chi squared test will be used. The difference between study groups will be considered significant when the P value will be <0.05. Statistical analysis will be performed by using the computer software SPSS 25.0
- Conditions
- Bifidobacterium Adolescentis PRL2019, IBS, Pediatric
- Being tested
- Gabapral, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapralDrug
This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to evaluate the efficacy and safety of Bifidobacterium adolescentis PRL2019 in pediatric patients (> 4 years) with IBS (as assessed according to the Rome IV diagnostic criteria for IBS).
The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period (Figure 1). After the screening phase, eligible patients will be randomly assigned to either 1 stick containing 20 Mld UFC of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy), or the equivalent placebo once a day, in a 1:1 ratio, for 12 weeks. Study visits will be conducted every 4 weeks during the treatment period.
PlaceboDrug
This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to evaluate the efficacy and safety of Bifidobacterium adolescentis PRL2019 in pediatric patients (> 4 years) with IBS (as assessed according to the Rome IV diagnostic criteria for IBS).
The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period (Figure 1). After the screening phase, eligible patients will be randomly assigned to either 1 stick containing 20 Mld UFC of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy), or the equivalent placebo once a day, in a 1:1 ratio, for 12 weeks. Study visits will be conducted every 4 weeks during the treatment period
| Study group | Role | What they receive |
|---|---|---|
| GABAPRAL | Experimental | Children with irritative bowel sindrome who received 20 Mld UFC of Bifidobacterium adolescentis PRL 2019 once a day for 12 weeks Receives: Drug: Gabapral |
| Placebo | Placebo comparator | Children with irritative bowel sindrome who received placebo once a day for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rome IV criteria
The primary outcome will be the improve in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period.
Measured: 2 months
Secondary outcomes (1)
bristol stool scale
Secondary outcomes will be modifications of bowel habits and safety.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bifidobacterium Adolescentis PRL2019Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera "Sant'Andrea"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Enrico Felici, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737277
- Sponsor's protocol ID
- GAB-IBSPED
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bifidobacterium Adolescentis PRL2019 in Pediatric Irritable Bowel Siyndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05737277
- Acronym / sponsor ID
- GAB-IBSPED
- Conditions
- Bifidobacterium Adolescentis PRL2019, IBS, Pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera "Sant'Andrea"University, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 21 Feb 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.
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder (FGID) characterized by recurrent episodes of defecation related abdominal pain associated with abnormal bowel habit. Several studies have reported significant alterations in the gut microbiota that may promote the development and persistence of IBS. Some Bifidobacterium species, mainly Bifidobacterium adolescentis, have a documented immunomodulatory effect and can modulate visceral hypersensitivity or improve the integrity of the intestinal epithelium barrier thorough its well-known ability to produce g-aminobutyric acid
Thus, designed a randomised, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of Bifidobacterium adolescentis PRL2019 on abdominal pain symptoms in pediatric patients with Irritative bowel sindorom
Detailed description
This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to evaluate the efficacy and safety of Bifidobacterium adolescentis PRL2019 in pediatric patients (> 4 years) with Irritative bpwel sindrome (as assessed according to the Rome IV diagnostic criteria for IBS).
The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period. After the screening phase, eligible patients will be randomly assigned to either 1 stick containing 20 Mld UFC of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy), or the equivalent placebo (without the active treatment, once a day, in a 1:1 ratio, for 12 weeks. Study visits will be conducted every 4 weeks during the treatment period. All the subjects will be blindly allocated by means of scratch cards to one of the two treatment groups according to a computer-generated randomisation list provided by our statistician. A validated program will be used by an independent statistician to generate a randomisation list with blocks, block size = 4, pre-allocated to centres. Patients and study investigators will be blinded to the randomisation codes. The codes will be kept confidential until the end of the study when the randomisation code will be broken after the database lock.
All subjects will undergo a formal clinical assessment and will be further phenotyped using validated questionnaires. Number of bowel movements per day and/or week and bowel habit characteristics, will be assessed by the Bristol stool scale.
The protocol will be approved by an independent ethics committee and conducted according to the Declaration of Helsinki and the principles of good clinical practice. The trial will be registered in a public registry.
The primary outcome will be the change in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period. Secondary outcomes will be modifications of bowel habits and safety.
Study patients
Eligible patients with symptoms meeting Rome IV criteria for diagnosis of Irritative bowel sindrome will be recruited from Sant'Andrea University Hospital.
Inclusion criteria will comprise a positive diagnosis of all Irritative Bowel Sindrome subtypes, at least 4 and no more of 17 years of age, negative fecal calprotectine and anti-transglutaminasi antibodies.
Exclusion criteria will include the current use of nonsteroidal anti-inflammatory drugs, corticosteroids and mast cell stabilisers, the use of topical or systemic antibiotics in the last month, or the continuous use of stimulant laxatives, major abdominal surgery, inflammatory bowel disease, infectious diarrhoea, allergic diseases and other organic or psychiatric disorders.
Statistical Analysis
The estimated total sample size that was aimed was 96 (48 children per arm) with the power of 80% (alpha of 5%). We estimated a dropout rate of 20% and aimed to recruit 120 participants to provide at least 96 evaluable assessments.
Difference between continuous variables will be assessed either by two-tailed Student t test for values with normal distribution or the MannWhitney test for non-normally distributed variables.
paired samples, based on distribution, Student t test for paired samples or Wilcoxon test will be used. To compare categorical variables chi squared test will be used. The difference between study groups will be considered significant when the P value will be <0.05. Statistical analysis will be performed by using the computer software SPSS 25.0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GABAPRAL | Experimental | Drug: GabapralChildren with irritative bowel sindrome who received 20 Mld UFC of Bifidobacterium adolescentis PRL 2019 once a day for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboChildren with irritative bowel sindrome who received placebo once a day for 12 weeks |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- IBS subtypes 4 -17 years of age,
- negative fecal calprotectine
- negative anti-transglutaminasi antibodies.
Key exclusion criteria (8 listed)
- the current use of nonsteroidal anti-inflammatory drugs, corticosteroids and mast cell stabilisers,
- the use of topical or systemic antibiotics in the last month,
- use of stimulant laxatives,
- major abdominal surgery,
- inflammatory bowel disease,
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 |
|---|---|---|
| GabapralThis will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to evaluate the efficacy and safety of Bifidobacterium adolescentis PRL2019 in pediatric patients (> 4 years) with IBS (as assessed according to the Rome IV diagnostic criteria for IBS). The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period (Figure 1). After the screening phase, eligible patients will be randomly assigned to either 1 stick containing 20 Mld UFC of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy), or the equivalent placebo once a day, in a 1:1 ratio, for 12 weeks. Study visits will be conducted every 4 weeks during the treatment period. | Drug | GABAPRAL |
| PlaceboThis will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to evaluate the efficacy and safety of Bifidobacterium adolescentis PRL2019 in pediatric patients (> 4 years) with IBS (as assessed according to the Rome IV diagnostic criteria for IBS). The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period (Figure 1). After the screening phase, eligible patients will be randomly assigned to either 1 stick containing 20 Mld UFC of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy), or the equivalent placebo once a day, in a 1:1 ratio, for 12 weeks. Study visits will be conducted every 4 weeks during the treatment period | Drug | Placebo |
Primary outcome
Rome IV criteria
Time frame: 2 months
The primary outcome will be the improve in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period.
1 secondary outcome
bristol stool scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapral in people with Bifidobacterium Adolescentis PRL2019 and IBS, run by Azienda Ospedaliera "Sant'Andrea".
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 3 inclusion and 8 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Giovanni Di Nardo, Prof (00393397267637, giovanni.dinardo@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rome IV criteria (time frame: 2 months). 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 21 Feb 2023.