Probiotics for infant colic

Completed

• Conditions: Infant colic; Neonatal Diseases

• Registration Number: ISRCTN13340073
• Lead Sponsor: Chr. Hansen A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-24
• Last Update Posted: 11 September 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. Infant colic defined as 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 III)
2. Exclusive breast fed infants at inclusion
3. Less than 3 months of age
4. Greater than 37 weeks gestation at birth
5. Birth weight of more than 2500 g

Exclusion Criteria

1. Formula fed or combination breast fed/ formula fed infants
2. Failure to thrive (weight gain < 100 grams/week averaged from birth to the last recorded weight)
3. Major medical problems (e.g. ill, immunocompromised, major developmental or genetic abnormality
4. Gastrointestinal disorder
5. Taking antibiotics four weeks prior to enrollment
6. Using probiotics in the past two weeks prior to enrollment
7. Taking antibiotics during intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of infants achieving a reduction in the daily crying/fussing time after 3 weeks treatment. Measured daily in diary. Baseline will be the mean of crying and fussing time measured daily in the diary during run in (day -7 to -1).

Secondary Outcome Measures

Name	Time	Method
1. Stool frequency and consistency, measured daily in diary using Amsterdam Stool Form. Baseline will be the mean frequency and consistency measured daily in the diary during run in (day -7 to -1)<br>2. Faecal IgA and calprotectin, measured at baseline (before intervention, day -1) and end of intervention (day 21)