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Completed

NCT Number: NCT03434249

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

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.

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Key information

Conditions

Infantile Colic Colic Colic, Infantile Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

Up to 7 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bifidobacterium, BB-12® (Bifidolactis Infant)

Dietary Supplement

Bifidolactis Infant Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

SOFAR S.p.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2018
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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