Infant ColicsPhase 4NCT01869426
Impact of Probiotic Preparation VSL#3 on Infants Colics
A Phase 4 study testing VSL#3 drops in people with Infant Colics, run by Policlinico Hospital at 1 site in Italy.
Trial summary
Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians. It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant… Read more about this study
- Who is it for?
- Ages 30 to 90 days
- Conditions the study is for
- Infant Colics
- What is being tested?
- VSL#3 drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Oct 2015
- Phase
- Phase 4
- 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 30 to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged between 30 and 90 days
- Breast fed exclusively during length of trial
- Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week but not treated previously for colics.
- Debut of colic symptoms 6+/-1 days before randomization
- Written informed consent from one or both parents
- Stated availability and reliability throughout the study period.
Who cannot join
- Major chronic disease
- Gastrointestinal disease
- Administration of antibiotics the week before randomization
- Administration of probiotics two weeks before randomization
- Infants with GI malformation, cystic fibrosis, other genetic diseases
- Participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, 70124
Maria Elisabetta Baldassarre, PhD, +393296114818, mariellabaldassarre@gmail.com
Maria Elisabetta Baldassarre, PhD
About this study
Official title: Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time
Infantile colic is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians.
It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition.
Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.
Read the detailed description
Aim of the study is to evaluate the improvement of colics symptoms by the oral administration of VSL#3 and the difference in the daily average crying time (measured with parental diary) between end of treatment and baseline.
In this study, 62 infants will be enrolled and will receive 10 drops per day of VSL#3 or Placebo according to randomization list. The study product will be supplied as a box containing the oil bottle and a powder stick. The product should be stored refrigerated. On the first day of supplementation, the mother will open the sachet, pour the contents into the bottle and shake vigorously. A dropper is provided to count the drops. The suspension must be shaken vigorously before every use. Compliance will be monitored by filling out a diary.
- Conditions
- Infant Colics
- Being tested
- VSL#3 drops, VSL#3 drops placebo
- Keywords
- colics
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3 dropsDietary supplement
VSL#3 drops placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| VSL#3 drops | Active comparator | 31 infants will receive 10 drops active product that should be taken daily (preferably in the morning before feeding) for 21 days. Receives: Dietary Supplement: VSL#3 drops |
| VSL#3 drops placebo | Placebo comparator | 31 infants will receive 10 drops of placebo product that should be taken daily (preferably in the morning before feeding) for 21 days. Receives: Dietary Supplement: VSL#3 drops placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of colics symptoms
improvement of colics symptoms by the oral administration of probiotic VSL#3 drops
Measured: 3 weeks
Secondary outcomes (1)
Difference in the daily average crying time between end of treatment and baseline.
Difference in the daily average crying time, measured with parental diary, between end of treatment and baseline.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant ColicsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
- Investigators
- Mariella Baldassarre, PhD, Principal investigator, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869426
- Sponsor's protocol ID
- VSLcolics13
- Status last verified
- Apr 2015
- First submitted
- 28 May 2013
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Baldassarre ME, Di Mauro A, Tafuri S, Rizzo V, Gallone MS, Mastromarino P, Capobianco D, Laghi L, Zhu C, Capozza M, Laforgia N. Effectiveness and Safety of a Probiotic-Mixture for the Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial with Fecal Real-Time PCR and NMR-Based Metabolomics Analysis. Nutrients. 2018 Feb 10;10(2):195. doi: 10.3390/nu10020195.
PubMed 29439395
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of VSL#3 on Infants Colics as Assessed by Average Crying Time
- ClinicalTrials.gov ID
- NCT01869426
- Acronym / sponsor ID
- VSLcolics13
- Conditions
- Infant Colics
- Keywords
- colics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 5 Jun 2013 (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 is one of the most commonly reported medical problems within the first three months of life causing appreciable distress for both parents and pediatricians.
It appears that multiple independent origins might be involved: amongst them infant's difficult temperament, inadequate mother-infant communication or maternal anxiety, transient lactase deficiency, exposure to cow's milk, abnormal gastrointestinal function, maternal smoking during pregnancy or after delivery. Consequently, various treatment approaches have been tried to alleviate this condition.
Recent studies have suggested that changes of intestinal microflora of a newborn may play an important role in pathogenesis of infantile colic. Therefore, dietary supplementation with probiotics has been proposed for the improvement of this condition.
Detailed description
Aim of the study is to evaluate the improvement of colics symptoms by the oral administration of VSL#3 and the difference in the daily average crying time (measured with parental diary) between end of treatment and baseline.
In this study, 62 infants will be enrolled and will receive 10 drops per day of VSL#3 or Placebo according to randomization list. The study product will be supplied as a box containing the oil bottle and a powder stick. The product should be stored refrigerated. On the first day of supplementation, the mother will open the sachet, pour the contents into the bottle and shake vigorously. A dropper is provided to count the drops. The suspension must be shaken vigorously before every use. Compliance will be monitored by filling out a diary.
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 |
|---|---|---|
| VSL#3 drops | Active comparator | Dietary Supplement: VSL#3 drops31 infants will receive 10 drops active product that should be taken daily (preferably in the morning before feeding) for 21 days. |
| VSL#3 drops placebo | Placebo comparator | Dietary Supplement: VSL#3 drops placebo31 infants will receive 10 drops of placebo product that should be taken daily (preferably in the morning before feeding) for 21 days. |
Who may qualify
- Ages
- 30 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants aged between 30 and 90 days
- Breast fed exclusively during length of trial
- Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week but not treated previously for colics.
- Debut of colic symptoms 6+/-1 days before randomization
- Written informed consent from one or both parents
Key exclusion criteria (6 listed)
- Major chronic disease
- Gastrointestinal disease
- Administration of antibiotics the week before randomization
- Administration of probiotics two weeks before randomization
- Infants with GI malformation, cystic fibrosis, other genetic diseases
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 |
|---|---|---|
| VSL#3 drops | Dietary supplement | VSL#3 drops |
| VSL#3 drops placebo | Dietary supplement | VSL#3 drops placebo |
Primary outcome
Improvement of colics symptoms
Time frame: 3 weeks
improvement of colics symptoms by the oral administration of probiotic VSL#3 drops
1 secondary outcome
Difference in the daily average crying time between end of treatment and baseline.
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Derived from this study: PubMed 29439395Baldassarre ME, Di Mauro A, Tafuri S, Rizzo V, Gallone MS, Mastromarino P, Capobianco D, Laghi L, Zhu C, Capozza M, Laforgia N. Effectiveness and Safety of a Probiotic-Mixture for the Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial with Fecal Real-Time PCR and NMR-Based Metabolomics Analysis. Nutrients. 2018 Feb 10;10(2):195. doi: 10.3390/nu10020195.
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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.
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, Italy
Mariella Baldassarre, PhD principal investigator
Policlinico Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VSL#3 drops in people with Infant Colics, run by Policlinico Hospital 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 6 inclusion and 6 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 1 May 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of colics symptoms (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869426, which also lists 1 linked publication.
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 1 May 2015.