Clinical Research

Our clinical research focuses on the impact of probiotic LR on infantile colic, which affects ~10% of full-term infants, especially on the changes of fecal microbiota, circulating Tregs, and inflammatory biomarkers. We found that infants with colic have an abnormal microbiota and increased fecal calprotectin (FC), a neutrophil product signifying intestinal inflammation. We completed & published a 3-year NCCAM NIH U01-funded study investigating the safety of daily LR and its impact on immunological profile in adults. Meanwhile, our group has also completed & published a small randomized, double-blind clinical trial analyzing prospectively the effect of a commercially available probiotic-containing formula (Nutramigen-Enflora, which has Lactobacillus GG) on microbiota and biomarkers in infants with colic. Recently, we completed a 2nd NCCAM NIH R34-funded study to investigate the safety of LR in healthy children with colic. We are currently applying to the Department of Defense to study in children with autism spectrum disease and gastrointestinal symptoms the best clinical instruments and effect size of probiotics, LR, on symptoms, autistic behavior, fecal microbial community, and markers of gastrointestinal inflammation.

Ms. Nicole Fatheree, Dr. Yuying Liu, Dr. Mike Ferris (New Orleans Children’s Hospital), and I are studying how probiotics may influence the fecal microbiota and immune system while being a contributing factor to infantile colic. We have determined via molecular analysis of the stools of 36 infants that infants with colic have a significantly greater chance of having Klebsiella spp. in their stool when compared to normal infants. All infants in this study were shown to have elevated levels of fecal calprotectin (a neutrophil marker), while colicky infants indicated a greater degree of inflammation in the gastrointestinal tract. We have satisfied FDA requirements for a Phase 1 Safety & Tolerability study in adult volunteers. We currently have funding to investigate the impact of BB-12 with Lactobacillus rhamnosus GG on children with autism and gastrointestinal symptoms. Other biomarkers include fecal microbiota and metabolites, circulating peripheral blood monocyte toll-like receptor (TLR) levels, and cytokine production. The study is a double-masked, placebo-controlled trial in children with autism.

For more information on colic or autism, please get in touch with us at 713.500.5669.

J. Marc Rhoads, MD, Professor
Division Director, Pediatric Gastroenterology
McGovern Medical School

Nicole Fatheree, BBA
Research, Pediatric Gastroenterology
McGovern Medical School

Yuying Liu, Ph.D., M.Ed, Associate Professor
Pediatric Gastroenterology
Director, Research
McGovern Medical School