NEOBIFI: Clinical Trial for the Prevention and/or Reduction of the Incidence of Colics in Infants

Plain-language summary

This study examined, compared with placebo, the effect of the probiotics Bifidobacterium breve BR03 and B632 in reducing the occurrence of infant colic in healthy newborns. It enrolled healthy babies aged 6 to 15 days, born by natural childbirth with a birth weight between 2500 and 4000 grams. It was carried out in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Intervention

Bifidobacterium breve BR03 and Bifidobacterium breve B632, Placebos

Start date

10/1/2013

Estimated completion

7/31/2017

Countries

Italy

Related genes

Locations

• Novara, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Only healthy babies term born
* Between 6 days and 15 days of life
* With a Birth weight between 2500 gr and 4000 gr
* With natural childbirth

Exclusion Criteria:

* Adverse reactions to the product or component of the product (allergies…)
* Antibiotic treatments
* Chronic diseases, hepatic or gastroenterological diseases
* Medical treatment for chronic diseases
* Probiotic or prebiotic therapies