Clinical trial NCT01849991: Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
Official title: Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastrointestinal
Colic
Keywords: Crying
Fussiness
Gas
Hydrogen Breath
Fecal Calprotectin
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 21
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.

Detailed description: This study will evaluate the safety and tolerability of Lactobacillus reuteri in healthy infants with colic. Patients will be randomized to receive either L. reuteri at one dose orally for a total of 42 doses. The doses will be 5x108 (5 drops) during a satisfactory assessment of safety and tolerability. The time on study treatment is 6 months, and the target sample size is 45 healthy infants.

Secondly, the investigators aim to gather evidence supporting hypothesis of safety and tolerability of Lactobacillus reuteri by administering a physical examination and testing of complete blood count, liver tests, and serum electrolytes over a forty-two day period.

Eligibility criteria: Inclusion Criteria:

* Full-term babies with colic (21-90 days old, who cry/fuss \> 3h daily x \> 3d wk)
* baby must have more than 3h crying for enrollment

Exclusion Criteria:

* severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis)
* failure to thrive
* intrauterine growth retardation
* hematochezia (blood in the stools)
* diarrhea (watery stools that takes the shape of a container \> 5x daily)
* fever (38.2 degrees)
* Premature infants (\<37 wk gestation)

Primary outcomes:
measure: 45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status.
timeFrame: 92 days
Secondary outcomes:
measure: Determine effect of L. reuteri in 45 infants with colic on gastrointestinal inflammation as assessed by fecal calprotectin.
timeFrame: 1, 42 & 92 days
Other outcomes:
measure: Measuring the change in crying times (Barr Diary) in 45 healthy infants with colic during the administration of L reuteri.
timeFrame: 92 days
measure: Determine effects of L. reuteri in 45 healthy infants with colic measuring the immunologic responses with plasma cytokines and circulating regulatory T-cells.
timeFrame: 1& 42 days
measure: Determine effect of L. reuteri on gastrointestinal inflammation as assessed by fecal microbiota in 45 healthy infants with colic.
timeFrame: 1, 42 & 92 days
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: J. Marc Rhoads, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fatheree NY, Liu Y, Taylor CM, Hoang TK, Cai C, Rahbar MH, Hessabi M, Ferris M, McMurtry V, Wong C, Vu T, Dancsak T, Wang T, Gleason W, Bandla V, Navarro F, Tran DQ, Rhoads JM. Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Pediatr. 2017 Dec;191:170-178.e2. doi: 10.1016/j.jpeds.2017.07.036. Epub 2017 Sep 29.
citation: Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31.