Probiotics and Colicky Infants

Probiotics are a heavily marketed supplement. A supplement that has some plausibility for certain types of health conditions. Like most unregulated supplements in the US there has been a cult industry built around it. It's promotion and use has consistently outstripped the scope of the research. Skeptoid covered probiotics briefly in a student question episode# 377. Where Brianexplored probiotics as a treatment for Antibiotic Related Diarrhea.

There are a multitude of probiotic drops marketed as "Clinically Proven" for Colicky infants. This is primarily based on a few preliminary small scale studies. A rigorous study published on April 1st in the BMJ shows no effect. Colicky infants are a nightmare for parents. Colic is difficult to treat and hard to diagnose(so called diagnosis of exclusion). Desperate parents looking for some help face limited medical options. Leaving them ripe targets for purveyors ofsham and worthless medical treatments.

Is probiotic therapy for colicky infants helpful or harmful?Could probiotics prevent or cure colic? If it does work are there any dangers? Lets take a close look at the data and to try to give a struggling mommy and daddy some good information to arm themselves with.

Probiotic literally means pro-life. In this context we will define it as an ingested "Microorganism"associated with beneficial effects to humans and animals.TheWorld Health Organization's 2001 definition of probiotics is "live micro-organisms which, when administered in adequate amounts, confer a health bene?t on the host". I think both definitions are slight presumptive given the paucity of evidence. Yet it is plausible that artificially introduced benign organisms provide a benefit. We do know that our endogenous intestinal flora is necessary for the normal functioning of the GI tract. It directly benefits food and water processing for maximum absorption. Through bacterial competition normal flora does provide direct protection from other microorganisms in the gut. The systemic (total body) benefit proposed by most probiotic manufacturers lacks plausibility and evidence. I think that Mark Crislip from the Society for Science Based Medicine wrote an excellent overview of probiotics in January 2013. So I will not retread it. Here is the link I suggest you read it, PROBIOTICS.

Colic, or as it is medically known Infantile Colic is a problem that can plague newborns and their parents. The cause is essentially unknown. There are some hypothesis that suggest that it is a gastrointestinal issue. In practice treating for GI issues have failed. It's diagnosis is what I call the rule of three. At least three hours of crying, three days a week, for at least three weeks in a otherwise completely healthy infant. For most parents suffering with this problem it is usually far more than just three hours a day. Only 5% have a diagnosed origin. Most of those 5% have a GI issue. Still 95% of cases have no discernible cause. It can last for up to a year and has no known treatment.

You can imagine how frustrating for some parents this can be. Constant inconsolable crying for a year. You can also imagine how this can make people desperate. Pediatricians try a multitude of unproven/disproven or anecdotal practices. Changes to formula, gas drops, and swaddling. Far fetched diagnosis abound, like infantile migraines. Smoking has a high co-morbidity although the mechanism is unclear. The one effective treatment is a gastric motility drug called Dicyclomine. It appears effective but it is a dangerous treatment for infants.

That does not mean that treating colic with probiotics is without merit. If colic originates from a gastrointestinal condition and normal gut flora plays a role it is possible that it could help. Realistically, that is a lot of if's. We know that gut flora develops as infants grow. (One of the reasons why newborn poop isn't quite as rancid as the 1 year old diapers) We also know that family members living in the same household share bacterial strains. It is plausible that these colicky infants are building up gut flora as they are growing. It is also plausible that until they develop a good population of gut flora they have excessive gas or motility resulting in pain. Leading the discussion back too that is a lot of if's. Trying probiotic organisms might be of benefit.

The general media widely reported that a BMJ study disproves the benefit of probiotic treatments in infants. As little as two months ago a JAMA pediatrics study showed the opposite. So what is a parent to do? Lets take an abbreviated look at both studies for scientific rigor.

Study 1: Prophylactic Use of a Probiotic in the Prevention of Colic, Regurgitation, and Functional Constipation.-A randomized controlled trial of589 infants were randomly allocated to receiveL reuteriDSM 17938 or placebo daily for 90 days.

Findings:Prophylactic use ofL reuteriDSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition.

Study 2: Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial.-To determine whether the probioticLactobacillus reuteriDSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.

Findings-L reuteriDSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.

After reviewing both studies I find the first study less compelling. The BMJ study structurally was much better. BMJ study randomized selection. Although the JAMA study did randomize patients into study groups, it was a selected population not randomized. Meaning that the investigators knew who they were putting into the study. The BMJ study did a much better job of controlling and monitoring for confounding factors.

"maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation withEscherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders."

The JAMA study did not control for any of these confounding variables. The BMJ also only specifically looked at Colic. The JAMA study included constipation and regurgitation. The BMJ evaluation included the independently quantifiable data of infant fecal bacterial data. The JAMA study was only parental diaries. Plus the study in JAMA was funded by a probiotic distributor and manufacturer. The BMJ study had no significant conflicts of interest.

Overall the poorly controlled confounding variables, wide spectrum of assessments, lack of a hard data point, and conflict of interest make the JAMA study a far less reliable evaluation.

There is no real data showing any risks in giving bacterial cultures to newborn infants. There is also no data showing safety.

My evaluation. Upon review of the literature the BMJ study is by far the best. The other studies related to this topic are even smaller and suffer from worse structural deficits than the JAMA study.

Overall I find little convincing evidence that probiotics will be of any help in relieving a colicky baby. Secondly the risks are unknown. Finally it is an expensive treatment. Probiotic supplements ranged from $12.99-29.99 for 0.17 floz.

So save your money, probiotics won't help and might hurt your infant.

I know it is tough I have seen the faces of devastated desperate parents in the ER at three in the morning. If throwing your money away makes you feel like you are doing something. Pay a trusted family member to watch the child for a few hours. Get some time out and away from the crying. It doesn't mean you are bad parents, everyone needs a break colicky baby or not. Plus be reassured that there are no long term problems or developmental issues associated with Colic.

Oh and one more thing.... Give up the cigarettes. Even if you are outside when you smoke you drag it back in on you. Trust me I smell it on you every time your in my office. It is the only controllable risk factor for Colic.


References:

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2107 (Published 1 April 2014)
Cite this as: BMJ 2014;348:g2107.

JAMA Pediatrics.2014;168(3):228-233.doi:10.1001/jamapediatrics.2013.4367.

http://www.bmj.com/content/348/bmj.g2286