Infantile ColicNCT02988791
Evaluation of a Probiotic (Bifidobacterium in the Treatment of Infantile Colic (IC)
A study testing probiotic (BIfidobacterium, BB-12®) in people with Infantile Colic, run by Federico II University at 1 site in Italy.
Trial summary
Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months: paroxysms of irritability, fussing, or crying that start and stop without obvious cause; episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least 1 week; and no failure to thrive. Read more about this study
- Who is it for?
- Ages 1 week to 7 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- probiotic (BIfidobacterium, BB-12®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2016to May 2018
- 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 1 week to 7 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- exclusively breastfed healthy infants of both sex, aged ≤ 7 weeks;
- Diagnosis of IC according to Rome III criteria
- Written informed consent of the parent/tutor
Who cannot join
- Birth weight<2500 g
- Gestational age<37 weeks
- APGAR 5 minutes <7
- Formula feeding
- Abnormal body growth/loss of weight (<100 g/weeks from birth to the last reported weight)
- Neurological diseases
Show all 19Show fewer
- Known or suspected food allergy
- Gastroesophageal reflux disease
- Use of substances that alter gut microbiota (pre/pro/synbiotic, antibiotics, gastric acidity inhibitors) or any anti-colic drug in the last 2 weeks prior the enrollment
- History of fever and/or infectious diseases in the last 2 weeks prior the enrollment
- Ongoing systemic infections
- History of congenital infections
- Chronic intestinal diseases (cystic fibrosis or other forms of pancreatic insufficiency primitive)
- Malformation of the gastrointestinal (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation), urinary or respiratory tract
- Metabolic diseases
- Genetic diseases and chromosomal abnormalities
- Primary or secondary immunodeficiencies
- Not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the Protocol
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy of Bifidobacterium in the Treatment of Infantile Colic (IC)
Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months: paroxysms of irritability, fussing, or crying that start and stop without obvious cause; episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least 1 week; and no failure to thrive. The condition is very common in the first 4 months of life (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive and inconsolable crying without an identifiable cause. Infantile colic cause considerable stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all pediatric visits in the first 4 months of life) and frequent formula changes.
The pathophysiology of IC is still poorly defined, but differences in gut microbiota composition seem to be involved. In particular, differences in the number and species of Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects with IC, and it has been postulated that these alterations could be responsible for an abnormal gas production within gut lumen resulting in distension and abdominal pain. These findings suggest the potential role of probiotics as preventive and therapeutic strategy for the IC.
- Conditions
- Infantile Colic
- Being tested
- probiotic (BIfidobacterium, BB-12®), Placebo
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic (BIfidobacterium, BB-12®)Dietary supplement
probiotic (Bifidobacterium, BB-12®)
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic (Bifidobacterium) | Experimental | Active, Bifidobacterium BB12 Receives: Dietary Supplement: probiotic (BIfidobacterium, BB-12®) |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean daily crying duration
reduction of ≥50% of mean daily crying duration
Measured: up to 28 days
Secondary outcomes (8)
number of regurgitation
Measured: up to 28 days
Evaluation of the gut microbiota modifications
Stool sample
Measured: up to 28 days
fecal production of peptides from innate immune system
Stool sample
Measured: up to 28 days
fecal short chain fatty acids production
Stool sample
Measured: 28 days
evacuative frequency
Measured: up to 28 days
consistency of the fecal mass
assessed by means of Bristol score
Measured: up to 28 days
number of crying episode
Measured: up to 28 days
sleep
duration of sleep
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- SOFAR S.p.A.
- Responsible party
- Principal investigator, Roberto Berni Canani, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988791
- Sponsor's protocol ID
- 250
- Status last verified
- Apr 2019
- First submitted
- 14 Nov 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy of Bifidobacterium in the Treatment of Infantile Colic (IC)
- ClinicalTrials.gov ID
- NCT02988791
- Acronym / sponsor ID
- 250
- Conditions
- Infantile Colic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- SOFAR S.p.A.
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 9 Dec 2016 (estimated)
- 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.
Infantile colic (IC) criteria includes all of the following in subjects aged ≤ 4 months: paroxysms of irritability, fussing, or crying that start and stop without obvious cause; episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least 1 week; and no failure to thrive. The condition is very common in the first 4 months of life (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive and inconsolable crying without an identifiable cause. Infantile colic cause considerable stress for the baby and the family, huge medical expenses (the IC cause 10-20 % of all pediatric visits in the first 4 months of life) and frequent formula changes.
The pathophysiology of IC is still poorly defined, but differences in gut microbiota composition seem to be involved. In particular, differences in the number and species of Lactobacilli spp, Klebsiella spp and Escherichia coli spp have been demonstrated in subjects with IC, and it has been postulated that these alterations could be responsible for an abnormal gas production within gut lumen resulting in distension and abdominal pain. These findings suggest the potential role of probiotics as preventive and therapeutic strategy for the IC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic (Bifidobacterium) | Experimental | Dietary Supplement: probiotic (BIfidobacterium, BB-12®)Active, Bifidobacterium BB12 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 1 week to 7 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- exclusively breastfed healthy infants of both sex, aged ≤ 7 weeks;
- Diagnosis of IC according to Rome III criteria
- Written informed consent of the parent/tutor
Key exclusion criteria (19 listed)
- Birth weight<2500 g
- Gestational age<37 weeks
- APGAR 5 minutes <7
- Formula feeding
- Abnormal body growth/loss of weight (<100 g/weeks from birth to the last reported weight)
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 |
|---|---|---|
| probiotic (BIfidobacterium, BB-12®)probiotic (Bifidobacterium, BB-12®) | Dietary supplement | Probiotic (Bifidobacterium) |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
mean daily crying duration
Time frame: up to 28 days
reduction of ≥50% of mean daily crying duration
8 secondary outcomes
number of regurgitation
Time frame: up to 28 days
Evaluation of the gut microbiota modifications
Time frame: up to 28 days
fecal production of peptides from innate immune system
Time frame: up to 28 days
fecal short chain fatty acids production
Time frame: 28 days
evacuative frequency
Time frame: up to 28 days
consistency of the fecal mass
Time frame: up to 28 days
number of crying episode
Time frame: up to 28 days
sleep
Time frame: up to 28 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 16 Apr 2019.
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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 probiotic (BIfidobacterium, BB-12®) in people with Infantile Colic, run by Federico II University 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 3 inclusion and 19 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 16 Apr 2019. 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 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?
mean daily crying duration (time frame: up to 28 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 16 Apr 2019.