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

January 13, 2020 updated by: SOFAR S.p.A.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 28 days from the baseline (Visit T5)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

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".
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)
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.
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)

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"
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)

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".
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)
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.
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)
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.
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)
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.
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)
Evaluation of calprotectin levels in fecal samples
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)
Evaluation of Beta-defensin type 2 levels in fecal samples
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)
Evaluation of LL37 peptide levels in fecal samples
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)
Evaluation of Butyrate levels in fecal samples
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)
Secretory immunoglobulin A (SIgA) levels in fecal samples
at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOFAR S.p.A.

Investigators

  • Principal Investigator: Roberto Berni Canani, Prof., Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2016

Primary Completion (Actual)

November 6, 2017

Study Completion (Actual)

November 6, 2017

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSC-DS BIGI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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