Patients needed for clinical trials on colic, excessive crying

Posted on Thursday, January 26th, 2012

The wail of a colicky baby can send parents into near panic and cause sleepless nights for all. Now, two innovative research studies are being conducted at the new UT Physicians Colic Clinic to help both crying babies and their worried parents.

“Somewhere between 10 and 20 percent of babies have colic. The condition has a terrible impact on the parents and may be one factor linked to a doubling of the number of infanticides over the past three decades,” says Marc Rhoads, M.D., UT Physicians pediatric gastroenterologist and director of the Endoscopy Laboratory at Children’s Memorial Hermann Hospital. “While reflux, which causes irritability, might be helped with a liquid acid blocker, a placebo-controlled study showed that crying time in babies with colic does not improve with acid blocker treatment.”

Colic is defined as inconsolable crying for more than three hours a day for more than three days a week for more than three weeks. It is associated with parental depression.

Dr. Rhoads is researching whether a supplement could be helpful while Christopher Greeley, M.D., UT Physicians pediatrician, is studying a behavioral approach.
Rhoads’ randomized, double-blinded trial examines a probiotic, a health-promoting bacteria called Lactobacillus rhamnosus GG (LGG), which may help relieve colic when added to formula. Dr. Rhoads and his colleagues previously satisfied Federal Drug Administration requirements for a safety and tolerability study for a similar Lactobacillus in adult volunteers before launching the pediatric trial.

“The gastrointestinal tract of infants, particularly preterm infants, is highly vulnerable because they haven’t completely developed their protective mechanisms,” Dr. Rhoads says. “Babies with colic have higher levels of breath hydrogen and abnormal fecal bacteria. We theorize that LGG can restore a healthy balance of bacteria in the gut and decrease the inflammation and excess hydrogen gas that are causing pain.”

Dr. Rhoads’ study will enroll 60 formula-fed infants at the colic clinic who are between 3 weeks and 3 months of age. They can be partially breast-fed.

In Dr. Greeley’s randomized trial, all parents of children with excessive crying will receive standard parental counseling. Half of the infants’ parents will also be taught an infant soothing technique. The study, funded by the National Institutes of Health, will enroll 180 infants.

“Compared to mothers of infants without colic, mothers of infants with colic have lower parental confidence and higher rates of depression,” Dr. Greeley says. “Despite its impact on families, few interventions for families with a colicky infant have been studied in well-designed randomized trials. We feel this study is a very important step in trying to identify ways to help parents and caregivers.”

For information on either trial, call 713.500.5669. To make an appointment at the Colic Clinic, located in the UT Professional Building, 6410 Fannin, call 832.525.2617.

- Deborah Mann Lake, Media Relations

The medical group practice of The University of Texas Medical School at Houston, UT Physicians offers the most advanced technologies with a personalized touch from its flagship location in the Texas Medical Center and at a growing number of clinics throughout the greater Houston area.

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