The Truth about Probiotics: Constipation Version

Families are often surprised to learn my opinion about probiotics.  The “truth” about probiotics is that they are poorly regulated/lack rigorous production standards and are mostly ineffective for many of the conditions for which they have been promoted.  Even in conditions in which there is some effectiveness (eg. antibiotic-associated diarrhea), the number of persons needed to treat for one person to benefit is fairly high.

In addition, when someone says that they are taking a probiotic, many families do not understand the idea of “strain” specific effects.  I tell families that if they see a “dog in yard” sign that they do not know if that is a poodle of a pit bull.  With probiotics, similarly you often do not know if you are getting a pit bull or a poodle.

As a consequence, I think negative studies like a recent report (K Wojtyniak et al. J Pediatr 2017; 184: 101-05) are helpful. In this study, the authors examined the effectiveness of Lactobacillus casei rhamnosus Lcr35 (Lcr35) in the management of constipation.

This randomized, double-blind, placebo-controlled trial was conducted in 94 children <5 years of age. Dose: 8 x10 to the 8th CFU twice daily x 4 weeks.

Key findings:

  • “Lcr35 as a sole treatment was not more effective than placebo in the management of functional constipation.” In fact, the placebo group had a greater increase in bowel movement frequency than the treatment group.
  • Both groups had improvement -more than half in each group (total 52 of 81 who completed study) had reached endpoint of 3 or more BMs/week without soiling.

My take: Probiotics often are ineffective.  This study showed that Lcr35 was NOT helpful for pediatric constipation.

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Claude Monet, La Rue Montorgueil

 

 

FDA Approves Plecanatide (Trulance) for Adults with Idiopathic Constipation

Here’s the link: FDA approves Trulance for Chronic Idiopathic Constipation (Jan 19.2017).  Plecanatide is a guanylate cyclase-C agonist.

An excerpt:

Trulance, taken orally once daily, works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.

The safety and efficacy of Trulance were established in two 12-week, placebo-controlled trials including 1,775 adult participants. Participants were randomly assigned to receive a placebo or Trulance, once daily. Participants in the trials were required to have been diagnosed with constipation at least six months prior to the study onset and to have less than three defecations per week in the previous three months, as well as other symptoms associated with constipation. Participants receiving Trulance were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and also had improvements in stool frequency and consistency and straining.

Trulance should not be used in children less than six years of age due to the risk of serious dehydration… The safety and effectiveness of Trulance have not been established in patients less than 18 years of age.

The most common and serious side effects of Trulance was diarrhea.

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Bowel Management Recommendations

A recent “consensus” review on bowel management (G Mosiello et al. JPGN 2017; 64: 343-52) is available as an open access article –Link: Consensus Review of Best Practic of Transanal Irrigation in Children

The use of bowel management tube (or cone) for transanal irrigation has been around since ~1987 (B Shandling et. al. J Ped Surg 1987; 22: 271-3) and generally is considered in children older than 3 years of age with severe problems with defecation (organic and functional).

This particular review has a very good table on troubleshooting (Table 4) and a succinct summary of indications/contraindications (Table 2).

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Here we go again …Miralax Safety Questioned

The issue of miralax safety is something that is discussed on a daily basis in pediatric gastroenterology offices.  It is back in the news.  The headlines suggest that there could be a problem but when one examines these stories we find that these reports have NOT shown data indicating a safety concern.

Here’s a link to a NASPGHAN Neurogastroenterology statement on safety of Miralax:

Here’s a link to a recent article in AJC questioning the safety of Miralax:

In this article, “the FDA told WPVI that there isn’t enough data “to demonstrate a link between PEG 3350 and serious neuropsychiatric issues in children.”

Bayer, MiraLAX’s manufacturer, said in part: “As part of Bayer’s ongoing commitment to consumer well-being, we regularly track, analyze and report all adverse event data related to the use of the product. Results of this ongoing monitoring support the continued safe use of MiraLAX.”

In a 2015 article on Parents.com, Dr. Steve J. Hodges, an associate professor of pediatric urology at the Wake Forest School of Medicine, pointed out that “more than 100 studies have found PEG 3350 is safe to use in children.”

“I have found no published studies linking MiraLAX to severe or harmful side-effects,” said Hodges, who was responding to a New York Times article about the Philadelphia study.”

Here’s a few other posts on Miralax safety:

Related blog posts:

My take (borrowed from expert review): “Generally speaking, if your child has been prescribed PEG 3350 as part of his/her treatment plan, and you feel this medicine provides benefit, you should feel safe continuing PEG 3350. At this time, PEG 3350 appears to be safe based on current medical literature. We recommend discussing any concerns you have about the safety of PEG 3350 with your child’s health care provider. If you would prefer for your child to stop taking PEG 3350, discuss other treatments options with your child’s health care team before stopping PEG 3350 therapy. Although abruptly stopping PEG 3350 is not considered dangerous, it could lead to a relapse/worsening of constipation.”

From 'this week in church signs'

From ‘this week in church signs’

Constipation Video from Primary Children’s Hospital

This is a really good educational video (< 8min) -now on YouTube: Constipation in Children: Understanding and Treating This Common Problem (Thanks to John Pohl’s twitter feed for this resource)

screenshot-78

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Soap Suds Enemas & ED Management of Impactions

A recent retrospective single-center study (CE Chumpiitazi et al. JPGN 2016; 63: 15-18) identified 512 patients (8 mo-23 years) who were treated with soap suds enemas (20 mL/kg of water with one packet of castile soap).  Key findings: No serious adverse events were identified. “82% were successfully treated.”

While this large study provides a fair amount of reassurance, the associated editorial (pg 1-2) makes some key points:

  • ED diagnosis of fecal impaction is unreliable.  “Abdominal radiographs are often performed…[but] have shown unsatisfactory sensitivity and specificity.”  In this study, only 38% had reported history of constipation; thus a high number of children developed impactions without prior constipation.  Thus, either many of these children were not impacted or the history was unreliable.
  • “SSEs are likely to be very effective, but so are phosphate enemas and milk and molasses enemas that have fallen out of favor because of safety concerns.”
  • In the editorial, until prospective studies are completed, the authors advocate considering oral PEG (high-dose) or ducosate enemas, normal saline enemas, glycerin enemas, mineral oil enemas, or bisacodyl enemas.

My take: While the editorial makes some valid points, particularly making sure that treatment for an impaction is needed, I think this study provides good preliminary data on the safety of soap suds enemas.  As with all pediatric treatments, more high-quality studies would be welcome.

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AJC Peachtree Road Race 2016

AJC Peachtree Road Race 2016

More than Two Years of Constipation Before Specialty Help

A recent article (S Malowitz et al. JPGN 2016; 62: 600-02) examined the age of onset of constipation in a retrospective review of 538 children with functional constipation between 2012-2014.

Key findings:

  • Median age of onset was 2.3 years
  • On average, “2.7 years pass between the onset of functional constipation and a referral to a specialist.”  In the oldest quartile, the lapse between onset and referral was shorter, 1.8 years.  This may reflect the social consequences of soiling in school-aged children.

The authors note: “encouraging clinicians and parents to think of constipation as a chronic problem with physical and mental health implications may improve outcomes and quality of life for affected children.”

My take: The suffering and burden of constipation is easily overlooked in a busy primary care visit.  This is a shame because this is one area where inexpensive specialty care (i.e. minimal testing) can truly make a big difference.

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Atlanta Zoo 2016

Atlanta Zoo 2016