CompletedNCT03434249Updated Jan 23, 2020Results posted

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

An interventional study of Bifidobacterium, BB-12® (Bifidolactis Infant) and Bifidolactis Infant Placebo in Infantile Colic and Colic, Infantile, sponsored by SOFAR S.p.A.. Completed at 1 site in Italy. Open to participants aged Up to 7 Weeks. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by SOFAR S.p.A. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: Up to 7 Weeks
Sex: All

Study 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.

Conditions studied

Infantile Colic
Colic, Infantile

Browse trials for

Colic 148

Keywords

Bifidobacterium

Who can participate

Ages eligible: Up to 7 Weeks
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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).
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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 80 participants (actual)

Study arms

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

Interventions

Dietary supplementBifidobacterium, BB-12® (Bifidolactis Infant)
Dietary supplementBifidolactis Infant Placebo

What researchers measure

Primary outcomes

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)
Time frame: at 28 days from the baseline (Visit T5)

Secondary outcomes

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.
Time frame: 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".
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
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.
Time frame: 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"
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Calprotectin
Evaluation of calprotectin levels in fecal samples
Time frame: 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
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
LL37 Peptide
Evaluation of LL37 peptide levels in fecal samples
Time frame: 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
Time frame: 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
Time frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)

Results

Posted Jan 23, 2020

Participant flow

The study was a randomized, double-blind, placebo-controlled parallel-group study. Eighty (80) infants were screened and all were enrolled in the study and randomized (40 to Bifidobacteriium BB-12® and 40 to Placebo). The enrollment period started on 11-Nov-2016 and closed on 6-Nov-2017.

Participant flow — Overall Study
Milestone	Bifidobacterium BB-12®	Placebo
Started	40	40
Completed	35	37
Not completed	5	3
Withdrew: Adverse event	1	0
Withdrew: Lost to follow-up	0	1
Withdrew: Non-compliance of family	2	1
Withdrew: Difficulties in completing daily diary	2	1

Outcome measures

PrimaryNumber 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)

Time frame:: at 28 days from the baseline (Visit T5)
Reported as:: Count of participants · Participants

Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
Participants	Bifidobacterium BB-12®	Placebo
Visit T5 - Success	32	13
Visit T5 - No Success	3	24
Visit T5 - Missing	5	3

Statistical analysis

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

SecondaryNumber 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.

Time frame:: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Reported as:: Mean · number of episodes

Number of Crying Episodes
number of episodes	Bifidobacterium BB-12®	Placebo
Visit T1 - Baseline	7.92 ± 2.79	8.28 ± 3.12
Visit T5	3.15 ± 1.48	6.04 ± 2.42

Statistical analysis

Bifidobacterium BB-12® vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.001

SecondaryInfectious 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".

Time frame:: at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5)
Reported as:: Mean · Number of infections

Infectious Diseases Incidence
Number of infections	Bifidobacterium BB-12®	Placebo
Infectious Diseases Incidence	0 ± 0	0 ± 0

SecondaryBowel 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.

Time frame:: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Reported as:: Mean · daily number of bowel evacuations

Bowel Evacuation - Stool Frequency
daily number of bowel evacuations	Bifidobacterium BB-12®	Placebo
Visti T1 - Baseline	5.30 ± 1.49	5.61 ± 1.60
Visit T2	5.15 ± 1.63	5.50 ± 1.54
Visit T3	4.92 ± 1.53	5.35 ± 1.45
Visit T4	4.51 ± 1.51	5.10 ± 1.24
Visit T5	4.34 ± 1.45	4.64 ± 1.23

Statistical analysis

Bifidobacterium BB-12® vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.001

SecondaryBowel 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"

Time frame:: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Reported as:: Number · participants

Bowel Evacuation - Stool Consistency
participants	Bifidobacterium BB-12®	Placebo
T1: Patients with at least 1 stool of type C	0	1
T1: Patients with at least one stool of type D	14	10
T1: Patients with at least one stool of type E	21	15
T1: Patients with at least one stool of type F	27	34
T1: Patients with at least one stool of type G	12	21
T2: Patients with at least one stool of type C	0	1
T2: Patients with at least one stool of type D	14	8
T2: Patients with at least one stool of type E	25	19
T2: Patients with at least one stool of type F	30	34
T2: Patients with at least one stool of type G	12	20
T3: Patients with at least one stool of type C	0	0
T3: Patients with at least one stool of type D	16	8
T3: Patients with at least one stool of type E	24	26
T3: Patients with at least one stool of type F	27	30
T3: Patients with at least one stool of type G	8	8
T4: Patients with at least one stool of type C	0	0
T4: Patients with at least one stool of type D	18	15
T4: Patients with at least one stool of type E	27	30
T4: Patients with at least one stool of type F	23	27
T4: Patients with at least one stool of type G	8	5
T5: Patients with at least one stool of type C	0	0
T5: Patients with at least one stool of type D	17	25
T5: Patients with at least one stool of type E	26	29
T5: Patients with at least one stool of type F	19	16
T5: Patients with at least one stool of type G	6	3

SecondaryInfant'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".

Time frame:: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Reported as:: Number · participants

Infant's Mood
participants	Bifidobacterium BB-12®	Placebo
T1: Pts with at least one mood equal to Calm	4	5
T1: Pts. with at least one mood equal to Asleep	5	6
T1: Pts. with at least one mood equal to Agitated	38	25
T1: Pts. with at least one mood equal to Irritable	36	36
T2: Pts. with at least one mood equal to Calm	14	7
T2: Pts. with at least one mood equal to Asleep	11	8
T2: Pts. with at least one mood equal to Agitated	37	32
T2: Pts. with at least one mood equal to Irritable	33	34
T3: Pts. with at least one mood equal to Calm	28	12
T3: Pts. with at least one mood equal to Asleep	12	8
T3: Pts. with at least one mood equal to Agitated	34	33
T3: Pts. with at least one mood equal to Irritable	25	30
T4: Pts. with at least one mood equal to Calm	35	15
T4: Pts. with at least one mood equal to Asleep	21	17
T4: Pts. with at least one mood equal to Agitated	32	36
T4: Pts. with at least one mood equal to Irritable	11	28
T5: Pts. with at least one mood equal to Calm	35	17
T5: Pts. with at least one mood equal to Asleep	27	23
T5: Pts. with at least one mood equal to Agitated	9	34
T5: Pts. with at least one mood equal to Irritable	5	20

SecondaryInfant'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.

Time frame:: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Reported as:: Mean · minutes

Infant's Sleep
minutes	Bifidobacterium BB-12®	Placebo
Visit T1 - baseline	678.14 ± 96.13	693.62 ± 121.79
Visit T2	687.47 ± 113.41	696.68 ± 121
Visit T3	722.37 ± 116.30	711.99 ± 128.87
Visit T4	725.76 ± 112.54	725.14 ± 131.74
Visit T5	713.20 ± 98.97	738.61 ± 141.58

SecondaryInfant'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.

Time frame:: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Reported as:: Mean · minutes

Infant's Temper
minutes	Bifidobacterium BB-12®	Placebo
Visit T1 - Baseline	158.82 ± 36.31	138 ± 34.71
Visit T2	118.61 ± 45.59	117.24 ± 58.32
Visit T3	89.48 ± 47.96	84.33 ± 46.76
Visit T4	71.71 ± 54.79	84.89 ± 58.04
Visit T5	36.79 ± 42.45	72.96 ± 40.22

SecondaryInfant'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.

Time frame:: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
Reported as:: Mean · minutes

Infant's Feeding
minutes	Bifidobacterium BB-12®	Placebo
Visit T1 - Baseline	187.72 ± 35.95	177.72 ± 34.66
Visit T2	186.13 ± 63.37	188.98 ± 32.75
Visit T3	179.80 ± 55.16	185.98 ± 30.98
Visit T4	180.31 ± 47.85	182.22 ± 28.70
Visit T5	176.47 ± 38.55	182.26 ± 27.20

SecondaryCalprotectin

Evaluation of calprotectin levels in fecal samples

Time frame:: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Reported as:: Mean · mM/Kg

Calprotectin
mM/Kg	Bifidobacterium BB-12®	Placebo
Visit T1 - Baseline	667.76 ± 162.06	658.47 ± 112.61
Visit T5	802.64 ± 131.33	915.41 ± 106.47

SecondaryBeta-defensin Type 2

Evaluation of Beta-defensin type 2 levels in fecal samples

Time frame:: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Reported as:: Mean · ng/g

Beta-defensin Type 2
ng/g	Bifidobacterium BB-12®	Placebo
Visit T1 - baseline	73.50 ± 10.92	69.41 ± 7.03
Visit T5	166.34 ± 43.79	127.97 ± 35.41

SecondaryLL37 Peptide

Evaluation of LL37 peptide levels in fecal samples

Time frame:: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Reported as:: Mean · ng/g

LL37 Peptide
ng/g	Bifidobacterium BB-12®	Placebo
Visit T1 - Baseline	5.50 ± 0.82	5.37 ± 0.83
Visit T5	7.65 ± 1.15	6.07 ± 1.41

SecondaryShort Chain Fatty Acids - Butyrate

Evaluation of Butyrate levels in fecal samples

Time frame:: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Reported as:: Mean · mM/Kg

Short Chain Fatty Acids - Butyrate
mM/Kg	Bifidobacterium BB-12®	Placebo
Visit T1 - Baseline	0.19 ± 0.14	0.17 ± 0.16
Visit T5	0.63 ± 0.49	0.32 ± 0.33

SecondarySecretory Immunoglobulin A (SIgA)

Secretory immunoglobulin A (SIgA) levels in fecal samples

Time frame:: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Reported as:: Mean · microg/g

Secretory Immunoglobulin A (SIgA)
microg/g	Bifidobacterium BB-12®	Placebo
Visit T1 - Baseline	84.79 ± 21.71	86.55 ± 12.13
Visit T5	250.65 ± 37.95	192.01 ± 27.12

Adverse events

Collected over 5 weeks starting from the patient enrollment. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Bifidobacterium BB-12®	0/40 (0%)	1/40 (2.5%)	0/40 (0%)
Placebo	0/40 (0%)	0/40 (0%)	0/40 (0%)

Most frequent serious events

Most frequent serious events
Event	Bifidobacterium BB-12®	Placebo
Respiratory distressRespiratory, thoracic and mediastinal disorders	1/40	0/40

Baseline characteristics

Age, Continuous
Age, Continuous(days)	Bifidobacterium BB-12®	Placebo	Total
Mean	33.05 ± 5.03	32.73 ± 5.69	32.89 ± 5.34

Sex: Female, Male
Sex: Female, Male(Participants)	Bifidobacterium BB-12®	Placebo	Total
Female	18	19	37
Male	22	21	43

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Bifidobacterium BB-12®	Placebo	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Bifidobacterium BB-12®	Placebo	Total
Italy	40	40	80

Type of childbirth
Type of childbirth(Participants)	Bifidobacterium BB-12®	Placebo	Total
Caesarean section	25	19	44
Natural childbirth	15	21	36

Gestational age
Gestational age(weeks)	Bifidobacterium BB-12®	Placebo	Total
Mean	38.43 ± 0.93	38.53 ± 1.20	38.48 ± 1.07

Birth weight
Birth weight(grams)	Bifidobacterium BB-12®	Placebo	Total
Mean	3280.75 ± 367.54	3412.00 ± 442.75	3346.38 ± 409.66

Apgar 5 minutes score
Apgar 5 minutes score(scores on a scale)	Bifidobacterium BB-12®	Placebo	Total
Mean	8.95 ± 0.39	8.83 ± 0.38	8.89 ± 0.39

5 further baseline measures are reported on the registry.

Study locations

1 site

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

References and documents

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 ↗

Study documents

Statistical analysis plan · Jan 16, 2018
Study protocol · Dec 4, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03434249
Lead sponsor: SOFAR S.p.A.
Responsible party: Sponsor
First posted: Feb 15, 2018
Start date: Nov 11, 2016
Primary completion: Nov 6, 2017
Completion: Nov 6, 2017
Results posted: Jan 23, 2020
Last update: Jan 23, 2020

Study contacts

Roberto Berni Canani, Prof.

principal investigator · Federico II University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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

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