Tags

Type your tag names separated by a space and hit enter

Probiotics to improve outcomes of colic in the community: protocol for the Baby Biotics randomised controlled trial.
BMC Pediatr 2012; 12:135BPed

Abstract

BACKGROUND

Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo.

METHODS/DESIGN

DESIGN

Double-blind, placebo-controlled randomised trial in Melbourne, Australia.

PARTICIPANTS

160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel's criteria of crying and/or fussing.

INTERVENTION

Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for one month.

PRIMARY OUTCOME

Infant crying/fussing time per 24 hours at one month.

SECONDARY OUTCOMES

i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at one and six months); and vii) infant faecal microbiota diversity, viii) infant faecal calprotectin levels and ix) Eschericia coli load (at one month only).

ANALYSIS

Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied.

DISCUSSION

An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention's simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN95287767.

Authors+Show Affiliations

Royal Children's Hospital, Parkville, Australia. valerie.sung@rch.org.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22928654

Citation

Sung, Valerie, et al. "Probiotics to Improve Outcomes of Colic in the Community: Protocol for the Baby Biotics Randomised Controlled Trial." BMC Pediatrics, vol. 12, 2012, p. 135.
Sung V, Hiscock H, Tang M, et al. Probiotics to improve outcomes of colic in the community: protocol for the Baby Biotics randomised controlled trial. BMC Pediatr. 2012;12:135.
Sung, V., Hiscock, H., Tang, M., Mensah, F. K., Heine, R. G., Stock, A., ... Wake, M. (2012). Probiotics to improve outcomes of colic in the community: protocol for the Baby Biotics randomised controlled trial. BMC Pediatrics, 12, p. 135. doi:10.1186/1471-2431-12-135.
Sung V, et al. Probiotics to Improve Outcomes of Colic in the Community: Protocol for the Baby Biotics Randomised Controlled Trial. BMC Pediatr. 2012 Aug 29;12:135. PubMed PMID: 22928654.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Probiotics to improve outcomes of colic in the community: protocol for the Baby Biotics randomised controlled trial. AU - Sung,Valerie, AU - Hiscock,Harriet, AU - Tang,Mimi, AU - Mensah,Fiona K, AU - Heine,Ralf G, AU - Stock,Amanda, AU - York,Elissa, AU - Barr,Ronald G, AU - Wake,Melissa, Y1 - 2012/08/29/ PY - 2012/08/16/received PY - 2012/08/24/accepted PY - 2012/8/30/entrez PY - 2012/8/30/pubmed PY - 2013/4/2/medline SP - 135 EP - 135 JF - BMC pediatrics JO - BMC Pediatr VL - 12 N2 - BACKGROUND: Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo. METHODS/DESIGN: DESIGN: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. PARTICIPANTS: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel's criteria of crying and/or fussing. INTERVENTION: Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for one month. PRIMARY OUTCOME: Infant crying/fussing time per 24 hours at one month. SECONDARY OUTCOMES: i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at one and six months); and vii) infant faecal microbiota diversity, viii) infant faecal calprotectin levels and ix) Eschericia coli load (at one month only). ANALYSIS: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied. DISCUSSION: An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention's simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95287767. SN - 1471-2431 UR - https://www.unboundmedicine.com/medline/citation/22928654/Probiotics_to_improve_outcomes_of_colic_in_the_community:_protocol_for_the_Baby_Biotics_randomised_controlled_trial_ L2 - https://bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-12-135 DB - PRIME DP - Unbound Medicine ER -