Prophylactic Use of a Probiotic in the Prevention of Colic, Regurgitation, and Functional Constipation: A Randomized Clinical Trial

Indrio F, Di Mauro A, Riezzo G, et al

JAMA Pediatr. 2014;168:228-233

Study Summary

Infantile colic, gastroesophageal reflux, and constipation are all common functional gastrointestinal disorders, and different organizational groups have established specific criteria for making these diagnoses. Growing evidence suggests that the intestinal microbiome may be related to multiple intestinal disorders, potentially including functional ones. This was a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial of using a Lactobacillus product (Lactobacillus reuteri DSM 17938) daily for 3 months to determine whether it was effective in preventing functional gastrointestinal disorders in the infants.

This study enrolled children at 9 pediatric centers in Italy from 2010 through 2012. The children were all born at 37-41 weeks' gestational age; were enrolled before 1 week of life; and had appropriate birthweight for gestational age, Apgar scores higher than 8 at 10 minutes, and no congenital diseases or malformations. Treatment-group children received the probiotic product suspended in oil. The children were given 5 drops of the oil each day for 90 days, and the placebo-group children received the same oil drops but without the active preparation mixed in. Parents and investigators were unaware of group assignment. In a diary, parents recorded symptoms such as episodes of regurgitation, minutes per day of inconsolable crying, and the number of daily stools. Parents also recorded outpatient medical visits, changes in formula or feeding regimen, hospitalizations, emergency department use, pharmacologic interventions including over-the-counter medications, and any lost parental work days. The infants were seen at visits with study personnel at least monthly, and the members of the study team contacted the family members at least weekly by phone during the 90 days. The primary analysis focused on whether administration of the probiotic reduced all 3 of the functional gastrointestinal disorders -- infantile colic (defined by the duration of inconsolable crying in minutes per day), reflux (episodes per day), and constipation (measured by stool frequency).

Study Findings

The treatment group had 238 children and the placebo group 230 children. There were no significant differences between the groups at enrollment or in attrition during the study. Differences in daily symptoms recorded by the parents at 1 and 3 months are summarized in the Table.

Table. Mean Daily Symptoms at 1 and 3 Months

Daily Symptoms	1 Month		3 Months
	Treatment	Placebo	Treatment	Placebo
Crying (minutes)	45	96	37.7	70.9
Stools (number)	4.01	2.8	4.2	3.6
Reflux (episodes)	No difference		2.9	4.6

 

Looking at secondary outcomes, treatment-group children had 44% fewer medical visits for gastrointestinal symptoms, 71% fewer emergency department visits, 82% fewer lost parental work days, and markedly less use of either prescribed or over-the-counter pharmacologic interventions. The study authors concluded that daily administration of probiotic to these infants was associated with a reduction in reported incidents of functional gastrointestinal symptoms.

Viewpoint

This is a very compelling study, and the investigators deserve credit for carrying it out in a double-blind fashion. An accompanying editorial^[1] reviews some of the recent data showing the potential physiologic conditions that may be affected by the gut microbiome and makes very interesting reading. The editorialists appropriately point out that the 90-day experimental phase in this study may not be long enough to detect either late beneficial or late adverse events that might occur, and they also mention the importance of testing different types of probiotic preparations to see whether they have similar benefits or adverse effects. The differences in healthcare utilization between the groups is striking, however (71% fewer emergency department visits by the treatment group is clinically and financially significant!). These differences are certainly significant enough to mean that additional multicenter clinical trials such as this one should be given priority to help infants and parents and perhaps reduce healthcare costs.

References

1. Chumpitazi BP, Shulman RJ. Five probiotic drops a day to keep infantile colic away? JAMA Pediatr. 2014;168:204-205.

An attitude of Gratitude

An attitude of Gratitude can go a long way in keeping us healthy....

How Being Grateful Can Actually Improve Your Health and Wellness

When I was growing up, we said "The Lord's Prayer," kneeling by our beds, morning and night. We said grace at every meal. It was habit and in retrospect, a lot of the words I said, I did by rote—not even considering what a phrase really meant; however, it did impress upon me the need to take a moment, take stock, and be grateful for everything I had in my life.

I didn't know it then, but having an attitude of gratitude can do more than just protect us from the perils of "affluenza."Dr. Tom Sult points out an article in Modern Healthcare Professionalthat explains how being grateful can actually improve our health.

Studies performed by researchers from University of California Davis revealed that consciously focusing on personal blessings can increase emotional and physical health. Another study, reported in Psychology Today, showed that people who show more gratitude in their daily lives enjoy better sleep and have lower levels of anxiety and depression. Additional studies show that people who demonstrate more gratitude have more activity in the hypothalamus, the part of the brain that controls important functions including eating, drinking, sleeping, metabolism and stress levels.

These studies are particularly interesting because they offer an additional approach to treating illness—one without a negative side effect.

Still, it's not always easy to remember to be grateful. We think about it annually on Thanksgiving as we sum up the reasons we're thankful. We certainly think about it when we realize we've escaped disaster.

It's a little harder to be grateful when we don't quite escape that looming abyss, but RTC author, Jim Jacoby, did. Jim recently shared the details of his harrowing motorcycle accident in his post on our community website. He describes his realization that despite having a cracked pelvis, broken wrist, torn muscles, and internal bleeding, he was immensely grateful it wasn't worse; that he had an excellent medical team, that the equipment he wore protected him, and that his wife, along with friends and even strangers, were there to help.

Sure, who doesn't want to be grateful? But we get busy. We forget. So how can we reap the benefits of a life filled with gratitude?

Like most successful actions, gratitude does have to be practiced, but it doesn't have to be a time-consuming process. Here are some tips:

• Give positive reminders of any rewards of a situation. So you're stuck in traffic. This is a great time to mentally review a presentation or just to jam to your favorite radio station.
• Don't compare yourselves others. The greatest effects from gratitude come when you focus your appreciation on what you have, instead of comparing yourself to others who might not have as much.
• Keep a daily or even weekly gratitude journal. Studies show that those who do have greater improvements in optimism, exercise patterns, and reduced physical ailments.
• Don't wait for next Thanksgiving to start intentionally being thankful. This minute is a great time to begin.

Want to be more grateful? Start by noticing a reason to be thankful each day, whether it's that your car's air conditioner works as it should, or that you found a $20 bill in your jeans pocket, or that a worrisome medical test result came back with good results. Practicing a thankful approach will help make gratitude a conscious habit. 

~ (Article curtesy of Just be well by Dr. Tom Sult)