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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434249
Recruitment Status : Completed
First Posted : February 15, 2018
Results First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
SOFAR S.p.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Infantile Colic Colic, Infantile Dietary Supplement: Bifidobacterium, BB-12® (Bifidolactis Infant) Dietary Supplement: Bifidolactis Infant Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective randomized double blind placebo controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Studio Clinico Randomizzato Per Valutare l'Efficacia Del Bifidobacterium BB-12® Nel Trattamento Delle Coliche Infantili
Actual Study Start Date : November 11, 2016
Actual Primary Completion Date : November 6, 2017
Actual Study Completion Date : November 6, 2017

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. Number of Crying Episodes [ Time Frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) ]

    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.


  2. 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) ]

    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".


  3. Bowel Evacuation - Stool Frequency [ Time Frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) ]
    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.

  4. Bowel Evacuation - Stool Consistency [ Time Frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) ]

    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"


  5. Infant's Mood [ Time Frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) ]

    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".


  6. Infant's Sleep [ Time Frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) ]
    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.

  7. Infant's Temper [ Time Frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) ]
    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.

  8. Infant's Feeding [ Time Frame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) ]
    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.

  9. Calprotectin [ Time Frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) ]
    Evaluation of calprotectin levels in fecal samples

  10. Beta-defensin Type 2 [ Time Frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) ]
    Evaluation of Beta-defensin type 2 levels in fecal samples

  11. LL37 Peptide [ Time Frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) ]
    Evaluation of LL37 peptide levels in fecal samples

  12. Short Chain Fatty Acids - Butyrate [ Time Frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) ]
    Evaluation of Butyrate levels in fecal samples

  13. Secretory Immunoglobulin A (SIgA) [ Time Frame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) ]
    Secretory immunoglobulin A (SIgA) levels in fecal samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 7 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434249


Locations
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Italy
Dipartimento di Scienze Mediche Traslazionali - Sezione Pediatria - Università degli Studi di napoli "Federico II"
Napoli, Italy, 80131
Sponsors and Collaborators
SOFAR S.p.A.
Investigators
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Principal Investigator: Roberto Berni Canani, Prof. Federico II University
  Study Documents (Full-Text)

Documents provided by SOFAR S.p.A.:
Statistical Analysis Plan  [PDF] January 16, 2018
Study Protocol  [PDF] December 4, 2019

Publications:

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Responsible Party: SOFAR S.p.A.
ClinicalTrials.gov Identifier: NCT03434249    
Other Study ID Numbers: PSC-DS BIGI
First Posted: February 15, 2018    Key Record Dates
Results First Posted: January 23, 2020
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SOFAR S.p.A.:
Bifidobacterium
Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases