The effect of probiotic supplements on infants with crying/fussing caused by digestive problems (colic)

Not Applicable

Completed

• Conditions: Colic; Signs and Symptoms

• Registration Number: ISRCTN92431452
• Lead Sponsor: Angel Children’s Hospital

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34568236/ (added 28/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-01
• Study Start: 2019-12-10
• Last Update Posted: 11 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. Crying or fussing episodes lasting more than 3 hours per day and occurring at least 3 days per week within 7 days prior to enrollment (ROME IV criteria)
2. Less than 3 months (12 weeks) of age
3. Equal to or greater than 37 weeks of gestation at birth
4. Vaginal delivery
5. Birth weight of more than 2500g
6. Provided voluntary written informed consent from parents of the infant

Exclusion Criteria

1. Average weight gain < 100 grams/week from birth to the last recorded weight
2. Major medical problems (e.g. immunocompromised disease, major developmental or genetic abnormality)
3. Gastrointestinal disorder
4. Taking antibiotics four weeks prior to enrollment
5. Using the same probiotic strains in this study two weeks prior to enrollment
6. Taking antibiotics during the intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified