Infantile ColicNCT03434249

Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic

A study testing Bifidobacterium, BB-12® (Bifidolactis Infant) in people with Infantile Colic and Colic, Infantile, run by SOFAR S.p.A. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic. Read more about this study

Who is it for?: Ages Up to 7 weeks
Conditions the study is for: Infantile Colic, Colic, Infantile
What is being tested?: Bifidobacterium, BB-12® (Bifidolactis Infant)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteItaly
Study dates: 11 Nov 2016to 6 Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Up to 7 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

Patients are included in the study if they meet all the following criteria:
Exclusively breastfed healthy infants of both sexes, aged ≤ 7 weeks.
Diagnosis of IC according to Rome III criteria.
Written informed consent of the parent/tutor.

Who cannot join

Patients are excluded from this study if they meet any of the following criteria:
Birth weight < 2500 g.
Gestational age < 37 weeks.
APGAR 5 minutes < 7.
Formula feeding.
Stunting/loss of weight (< 100 g/weeks from birth to the last reported weight).

Show all 20Show fewer

Neurological diseases.
Known or suspected food allergy.
Gastroesophageal reflux disease.
Use of substances that alter gut microbiota (probiotics, prebiotics, antibiotics, gastric acidity inhibitors) in the last 2 weeks prior the enrollment.
History of fever and/or infectious diseases in the last 2 weeks prior to enrollment.
Ongoing systemic infections.
History of congenital infections.
Chronic intestinal diseases (cystic fibrosis or other forms of primitive pancreatic insufficiency)
Primitive or secondary malformations of the gastrointestinal tract (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation).
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.

Italy1 site

Dipartimento di Scienze Mediche Traslazionali - Sezione Pediatria - Università degli Studi di napoli "Federico II"
Naples, 80131

Other trials in Italy

About this study

Official title: Studio Clinico Randomizzato Per Valutare l'Efficacia Del Bifidobacterium BB-12® Nel Trattamento Delle Coliche Infantili

This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.

Conditions: Infantile Colic, Colic, Infantile
Being tested: Bifidobacterium, BB-12® (Bifidolactis Infant), Bifidolactis Infant Placebo
Keywords: Bifidobacterium
Medical subject headings: Colic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bifidobacterium, BB-12® (Bifidolactis Infant)Dietary supplement
Bifidolactis Infant PlaceboDietary supplement

Study groups in NCT03434249
Study group	Role	What they receive
Group I	Experimental	patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days; Receives: Dietary Supplement: Bifidobacterium, BB-12® (Bifidolactis Infant)
Group II	Placebo comparator	patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days. Receives: Dietary Supplement: Bifidolactis Infant Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary.
Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well.
The following categories of patients has been defined:
Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)
Measured: at 28 days from the baseline (Visit T5)

Secondary outcomes (13)

Number of Crying Episodes
Weekly mean of cries will be defined as the mean number of cries reported in the "Evaluation of behavior" section during the week (i.e. number of episodes/number of days with episodes) and will be described by means of descriptive statistics for continuous data.
Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be analyzed too.
Measured: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Infectious Diseases Incidence
Number of infections in respiratory system, gastrointestinal system, urinary tract and skin.
An infection was defined as an Adverse Event with SOC equal to "Infections and Infestations".
Measured: at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5)
Bowel Evacuation - Stool Frequency
Daily frequency of bowel evacuation. The frequency of stools were collected daily in the diary. Stool frequency was evaluated as the mean of total daily stools reported per week.
Measured: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Bowel Evacuation - Stool Consistency
Stool consistency was evaluated as the number and the proportion of patients who reported at least one stool sample of each type per week, according to Bristol scale as follows:
Type A = separate hard lumps, like nuts (hard to pass) Type B = sausage-shaped, but lumpy Type C = Like a sausage but with cracks on its surface Type D = like a sausage or snake, smooth and soft Only a descriptive statistics Type E = soft blobs with clear-cut edges (passed easily) Type F = fluffy pieces with ragged edges, a mushy stool Type G = watery, no solid pieces (entirely liquid). Patients could report more than one stool consistency per day then the sum of the "Count of Participants" for each group at each visit could be Greater then the "Overall Number of Participants Analyzed"
Measured: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Mood
The infant's mood (calm, asleep, agitated, irritable) was collected daily in the diary and was evaluated as the number and the proportion of infants who reported at least one mood of each type per week.
Patients could report more than one mood per day then the sum of the "Count of Participants" for each group at each visit could be greater then the "Overall Number of Participants Analyzed".
Measured: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Sleep
Duration of sleep (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of sleep by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.
Measured: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Temper
Duration of temper episodes (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of temper episodes by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.
Measured: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Feeding
Duration of feeding (in minutes) was collected daily in the diary during the entire study period. Mean daily feeding time by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.
Measured: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Calprotectin
Evaluation of calprotectin levels in fecal samples
Measured: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Beta-defensin Type 2
Evaluation of Beta-defensin type 2 levels in fecal samples
Measured: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
LL37 Peptide
Evaluation of LL37 peptide levels in fecal samples
Measured: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Short Chain Fatty Acids - Butyrate
Evaluation of Butyrate levels in fecal samples
Measured: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Secretory Immunoglobulin A (SIgA)
Secretory immunoglobulin A (SIgA) levels in fecal samples
Measured: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 20166 Nov 2017

First posted15 Feb 2018
Study start11 Nov 2016
Primary completion6 Nov 2017
Study completion6 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Infantile ColicStudies 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: This is a prospective randomized double blind placebo controlled clinical trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03434249
Sponsor's protocol ID: PSC-DS BIGI
Status last verified: Jan 2020
First submitted: 9 Feb 2018
Last updated: 23 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hyman PE, Milla PJ, Benninga MA, Davidson GP, Fleisher DF, Taminiau J. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology. 2006 Apr;130(5):1519-26. doi: 10.1053/j.gastro.2005.11.065.
PubMed 16678565
Szajewska H, Gyrczuk E, Horvath A. Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2013 Feb;162(2):257-62. doi: 10.1016/j.jpeds.2012.08.004. Epub 2012 Sep 14.
PubMed 22981952
Kabeerdoss J, Devi RS, Mary RR, Prabhavathi D, Vidya R, Mechenro J, Mahendri NV, Pugazhendhi S, Ramakrishna BS. Effect of yoghurt containing Bifidobacterium lactis Bb12(R) on faecal excretion of secretory immunoglobulin A and human beta-defensin 2 in healthy adult volunteers. Nutr J. 2011 Dec 23;10:138. doi: 10.1186/1475-2891-10-138.
PubMed 22196482
Mohan R, Koebnick C, Schildt J, Mueller M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on body weight, fecal pH, acetate, lactate, calprotectin, and IgA in preterm infants. Pediatr Res. 2008 Oct;64(4):418-22. doi: 10.1203/PDR.0b013e318181b7fa.
PubMed 18552710
Mohan R, Koebnick C, Schildt J, Schmidt S, Mueller M, Possner M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on intestinal microbiota of preterm infants: a double-blind, placebo-controlled, randomized study. J Clin Microbiol. 2006 Nov;44(11):4025-31. doi: 10.1128/JCM.00767-06. Epub 2006 Sep 13.
PubMed 16971641
Savino F, Cordisco L, Tarasco V, Calabrese R, Palumeri E, Matteuzzi D. Molecular identification of coliform bacteria from colicky breastfed infants. Acta Paediatr. 2009 Oct;98(10):1582-8. doi: 10.1111/j.1651-2227.2009.01419.x. Epub 2009 Jul 9.
PubMed 19604166
Hall B, Chesters J, Robinson A. Infantile colic: a systematic review of medical and conventional therapies. J Paediatr Child Health. 2012 Feb;48(2):128-37. doi: 10.1111/j.1440-1754.2011.02061.x. Epub 2011 Apr 7.
PubMed 21470331
Savino F, Bailo E, Oggero R, Tullio V, Roana J, Carlone N, Cuffini AM, Silvestro L. Bacterial counts of intestinal Lactobacillus species in infants with colic. Pediatr Allergy Immunol. 2005 Feb;16(1):72-5. doi: 10.1111/j.1399-3038.2005.00207.x.
PubMed 15693915
Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, Silvestro L, Oggero R. Intestinal microflora in breastfed colicky and non-colicky infants. Acta Paediatr. 2004 Jun;93(6):825-9.
PubMed 15244234
Gupta SK. Is colic a gastrointestinal disorder? Curr Opin Pediatr. 2002 Oct;14(5):588-92. doi: 10.1097/00008480-200210000-00005.
PubMed 12352253
Lucassen PL, Assendelft WJ, van Eijk JT, Gubbels JW, Douwes AC, van Geldrop WJ. Systematic review of the occurrence of infantile colic in the community. Arch Dis Child. 2001 May;84(5):398-403. doi: 10.1136/adc.84.5.398.
PubMed 11316682
BRAZELTON TB. Crying in infancy. Pediatrics. 1962 Apr;29:579-88. No abstract available.
PubMed 13872677
Iacovou M, Ralston RA, Muir J, Walker KZ, Truby H. Dietary management of infantile colic: a systematic review. Matern Child Health J. 2012 Aug;16(6):1319-31. doi: 10.1007/s10995-011-0842-5.
PubMed 21710185

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Effect of Probiotics in Infantile Colic
Infantile Colic
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Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
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All Infantile Colic trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Studio Clinico Randomizzato Per Valutare l'Efficacia Del Bifidobacterium BB-12® Nel Trattamento Delle Coliche Infantili
ClinicalTrials.gov ID: NCT03434249
Acronym / sponsor ID: PSC-DS BIGI
Conditions: Infantile Colic, Colic, Infantile
Keywords: Bifidobacterium
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: SOFAR S.p.A.Industry (pharma, biotech, devices)
Study start: 11 Nov 2016 (actual)
Primary completion: 6 Nov 2017 (actual)
Study completion: 6 Nov 2017 (actual)
First posted: 15 Feb 2018 (actual)
Results: Posted 23 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.

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: This is a prospective randomized double blind placebo controlled clinical trial

Arm	Type	Receives
Group I	Experimental	Dietary Supplement: Bifidobacterium, BB-12® (Bifidolactis Infant)patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;
Group II	Placebo comparator	Dietary Supplement: Bifidolactis Infant Placebopatients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.

Who may qualify

Ages: Up to 7 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Exclusively breastfed healthy infants of both sexes, aged ≤ 7 weeks.
Diagnosis of IC according to Rome III criteria.
Written informed consent of the parent/tutor.

Key exclusion criteria (20 listed)

Birth weight < 2500 g.
Gestational age < 37 weeks.
APGAR 5 minutes < 7.
Formula feeding.
Stunting/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
Bifidobacterium, BB-12® (Bifidolactis Infant)	Dietary supplement	Group I
Bifidolactis Infant Placebo	Dietary supplement	Group II

Primary outcome

Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
Time frame: at 28 days from the baseline (Visit T5)
Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary. Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well. The following categories of patients has been defined: Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)

13 secondary outcomes

Number of Crying Episodes
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Infectious Diseases Incidence
Time frame: at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5)
Bowel Evacuation - Stool Frequency
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Bowel Evacuation - Stool Consistency
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Mood
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Sleep
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Temper
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Infant's Feeding
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Calprotectin
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Beta-defensin Type 2
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
LL37 Peptide
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Short Chain Fatty Acids - Butyrate
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Secretory Immunoglobulin A (SIgA)
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)

Results and safety

Results posted to the registry on 23 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bifidobacterium BB-12®	40	35
Placebo	40	37

Primary outcome: Number of Participants With >=50% Reduction in Mean Weekly Crying Duration

Time frame: at 28 days from the baseline (Visit T5). Count of participants. Unit: Participants

Measure	Bifidobacterium BB-12® n = 40	Placebo n = 40
Visit T5 - Success	32	13
Visit T5 - No Success	3	24
Visit T5 - Missing	5	3

Bifidobacterium BB-12® vs Placebo: p = 0.0001, Chi-squared

Population analysed: Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they were assigned to at the randomization visit. Patients drop-out were also considered and classified as Treatment success rate = "Missing".

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 weeks starting from the patient enrollment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bifidobacterium BB-12®	1 of 40 (2.5%)	0 of 40 (0%)	0 of 40
Placebo	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16678565Hyman PE, Milla PJ, Benninga MA, Davidson GP, Fleisher DF, Taminiau J. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology. 2006 Apr;130(5):1519-26. doi: 10.1053/j.gastro.2005.11.065.
Background: PubMed 22981952Szajewska H, Gyrczuk E, Horvath A. Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2013 Feb;162(2):257-62. doi: 10.1016/j.jpeds.2012.08.004. Epub 2012 Sep 14.
Background: PubMed 22196482Kabeerdoss J, Devi RS, Mary RR, Prabhavathi D, Vidya R, Mechenro J, Mahendri NV, Pugazhendhi S, Ramakrishna BS. Effect of yoghurt containing Bifidobacterium lactis Bb12(R) on faecal excretion of secretory immunoglobulin A and human beta-defensin 2 in healthy adult volunteers. Nutr J. 2011 Dec 23;10:138. doi: 10.1186/1475-2891-10-138.
Background: PubMed 18552710Mohan R, Koebnick C, Schildt J, Mueller M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on body weight, fecal pH, acetate, lactate, calprotectin, and IgA in preterm infants. Pediatr Res. 2008 Oct;64(4):418-22. doi: 10.1203/PDR.0b013e318181b7fa.
Background: PubMed 16971641Mohan R, Koebnick C, Schildt J, Schmidt S, Mueller M, Possner M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on intestinal microbiota of preterm infants: a double-blind, placebo-controlled, randomized study. J Clin Microbiol. 2006 Nov;44(11):4025-31. doi: 10.1128/JCM.00767-06. Epub 2006 Sep 13.
Background: PubMed 19604166Savino F, Cordisco L, Tarasco V, Calabrese R, Palumeri E, Matteuzzi D. Molecular identification of coliform bacteria from colicky breastfed infants. Acta Paediatr. 2009 Oct;98(10):1582-8. doi: 10.1111/j.1651-2227.2009.01419.x. Epub 2009 Jul 9.
Background: PubMed 21470331Hall B, Chesters J, Robinson A. Infantile colic: a systematic review of medical and conventional therapies. J Paediatr Child Health. 2012 Feb;48(2):128-37. doi: 10.1111/j.1440-1754.2011.02061.x. Epub 2011 Apr 7.
Background: PubMed 15693915Savino F, Bailo E, Oggero R, Tullio V, Roana J, Carlone N, Cuffini AM, Silvestro L. Bacterial counts of intestinal Lactobacillus species in infants with colic. Pediatr Allergy Immunol. 2005 Feb;16(1):72-5. doi: 10.1111/j.1399-3038.2005.00207.x.
Background: PubMed 15244234Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, Silvestro L, Oggero R. Intestinal microflora in breastfed colicky and non-colicky infants. Acta Paediatr. 2004 Jun;93(6):825-9.
Background: PubMed 12352253Gupta SK. Is colic a gastrointestinal disorder? Curr Opin Pediatr. 2002 Oct;14(5):588-92. doi: 10.1097/00008480-200210000-00005.
Background: PubMed 11316682Lucassen PL, Assendelft WJ, van Eijk JT, Gubbels JW, Douwes AC, van Geldrop WJ. Systematic review of the occurrence of infantile colic in the community. Arch Dis Child. 2001 May;84(5):398-403. doi: 10.1136/adc.84.5.398.
Background: PubMed 13872677BRAZELTON TB. Crying in infancy. Pediatrics. 1962 Apr;29:579-88. No abstract available.
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.

Roberto Berni Canani, Prof. principal investigator

Federico II University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bifidobacterium, BB-12® (Bifidolactis Infant) in people with Infantile Colic and Colic, Infantile, run by SOFAR S.p.A. 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 20 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 23 Jan 2020. 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?

Yes. Results are posted in the registry (first posted 23 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With >=50% Reduction in Mean Weekly Crying Duration (time frame: at 28 days from the baseline (Visit T5)). 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 NCT03434249, which also lists 13 linked publications.

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 23 Jan 2020.