Baby Biotics: Do probiotics help crying babies and their families?

Impact of Lactobacillus reuteri DSM 17938 on infant colic and parent mental health: a randomised double-blinded, placebo-controlled trial in breast and formula fed infants less than 3 months old

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95287767

Enrollment

160

Registered

2010-10-25

Start date

2011-05-30

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant colic Pregnancy and Childbirth Colic

Interventions

The intervention is Lactobacillus reuteri DSM 17938 at the concentration of 0.2 x 10^8 cfu in an oil suspension. It is administered orally to each infant as 5 drops per day (total dose 1 x 10^8 cfu/da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants less than 3 months old (up to and excluding 13.0 weeks) with: 1. Infant colic, ie crying more than 3 hours/day for more than 3 days over 7 days (as defined by the modified Wessel's criteria) by caregiver's report 2. More than 36 weeks gestation at birth 3. Birth weight more than 2500 g

Exclusion criteria

Exclusion criteria: 1. Infants with failure to thrive (weight gain less than 20 g/day averaged from birth to the last recorded weight) 2. Infants with major medical problems (eg. ill, immunocompromised, infants with major developmental or chromosomal abnormalities) 3. Infants or breastfeeding mothers using antibiotics or probiotics at the time of study recruitment 4. Families with insufficient English to understand informed consent or complete questionnaires

Design outcomes

Primary

Measure	Time frame
Mean infant crying time (minutes per 24 hours), measured by the Barr diary, a validated measure of infant crying, at 28 days	—

Secondary

Measure	Time frame
1. Mean infant crying time (minutes per 24 hours), measured by the Barr diary, a validated measure of infant crying, at 7, 14, 21 days and at 6 months 2. Mean number of episodes of infant crying per 24 hours, measured by the Barr diary, a validated measure of infant crying, at 7, 14, 21, 28 days and at 6 months 3. Mean infant sleep duration (minutes per 24 hours), measured by the Barr diary, a validated measure of infant sleep duration, at 7, 14, 21, 28 days and at 6 months 4. Mean maternal mental health scores, measured by the Edinburgh Postnatal Depression Scale, with higher scores indicating more symptoms of depression, at 1 and 6 months 5. Mean infant and family functioning scores, measured by the PedsQL Infant and Family Impact scores, with higher scores indicating better functioning, at 1 and 6 months 6. Mean parent quality adjusted life years (QALY) scores, measured by the AQoL-4D, a 12-item validated questionnaire to assess QALY and subsequently intervention cost-effectiveness, at 1 and 6 months 7. Infant faecal microbiota diversity, measured by 16S RNA amplification, at 1 month 8. Infant faecal calprotectin levels, measured by ELISA, at 1 month	—

Measure

Time frame

1. Mean infant crying time (minutes per 24 hours), measured by the Barr diary, a validated measure of infant crying, at 7, 14, 21 days and at 6 months 2. Mean number of episodes of infant crying per 24 hours, measured by the Barr diary, a validated measure of infant crying, at 7, 14, 21, 28 days and at 6 months 3. Mean infant sleep duration (minutes per 24 hours), measured by the Barr diary, a validated measure of infant sleep duration, at 7, 14, 21, 28 days and at 6 months 4. Mean maternal mental health scores, measured by the Edinburgh Postnatal Depression Scale, with higher scores indicating more symptoms of depression, at 1 and 6 months 5. Mean infant and family functioning scores, measured by the PedsQL Infant and Family Impact scores, with higher scores indicating better functioning, at 1 and 6 months 6. Mean parent quality adjusted life years (QALY) scores, measured by the AQoL-4D, a 12-item validated questionnaire to assess QALY and subsequently intervention cost-effectiveness, at 1 and 6 months 7. Infant faecal microbiota diversity, measured by 16S RNA amplification, at 1 month 8. Infant faecal calprotectin levels, measured by ELISA, at 1 month

—

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026