Can supplementation with a probiotic reduce the crying time and modify the gut microbiome in a group of infants with colic?

Not Applicable

Completed

• Conditions: Infantile colic; Signs and Symptoms

• Registration Number: ISRCTN16554977
• Lead Sponsor: Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino

Brief Summary

2020 results in https://doi.org/10.3390/nu12061693 (added 02/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-30
• Study Start: 2020-05-16
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

1. Aged between 2 and 10 weeks
2. Gestational age between 37 and 40 weeks
3. Birth weight between 2700 g and 4200 g,
4. Exclusively breastfed
5. Colic, as diagnosed according to the Wessel definition modified by Roma IV criteria (infants have at least three episodes of unexplained full-force crying lasting more than three hours per day on at least three days a week for at least one week)
6. Maternal willingness and ability to avoid dietary cow’s milk

Exclusion Criteria

1. Clinical evidence of chronic illness or gastrointestinal disorders
2. Antibiotic or probiotic treatment in the week preceding recruitment

Study & Design

• Study Type: Interventional
• Study Design: Not specified