Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic

NCT01849991 | Completed Phase 1 DMC

• 2 other identifiers: HSC-11-0203HSC-MS-11-0203
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal; Colic

Keywords

Crying; Fussiness; Gas; Hydrogen Breath; Fecal Calprotectin

Outcome Measures

Primary Outcomes (1)

• 45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status.

  1. Physical Examination of infants will be performed to evaluate any adverse effects of LR. 2. Electrolyte testing at baseline will evaluate for any inborn error of fluid and electrolyte balance and at end of treatment will evaluate for any adverse impact of LR in the subjects.

  92 days

Secondary Outcomes (1)

• Determine effect of L. reuteri in 45 infants with colic on gastrointestinal inflammation as assessed by fecal calprotectin.

  1, 42 & 92 days

Other Outcomes (3)

• Measuring the change in crying times (Barr Diary) in 45 healthy infants with colic during the administration of L reuteri.

  92 days

• Determine effects of L. reuteri in 45 healthy infants with colic measuring the immunologic responses with plasma cytokines and circulating regulatory T-cells.

  1& 42 days

• Determine effect of L. reuteri on gastrointestinal inflammation as assessed by fecal microbiota in 45 healthy infants with colic.

  1, 42 & 92 days

Study Arms (2)

Lactobacillus reuteri

ACTIVE COMPARATOR

The first arm of the cohort will include 30 patients on LR (5x10\^8 cfu's orally once daily.)

Biological: Lactobacillus reuteri

Sunflower Oil

PLACEBO COMPARATOR

The second arm includes 15 subjects on placebo (sunflower oil.)

Biological: Placebo

Interventions

Lactobacillus reuteri BIOLOGICAL

Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment of a well-functioning gastrointestinal (GI) microbiota and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The drug is a clear liquid when suspended in sunflower oil. The drug will be administered orally, 0.2cc once daily.

Lactobacillus reuteri

Placebo BIOLOGICAL

Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.

Sunflower Oil

Eligibility Criteria

• Age: 3 Weeks - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 28969890 RESULT

• 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.

  PMID: 30177353 DERIVED

MeSH Terms

Conditions

Colic; Crying; Mucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nonverbal Communication; Communication; Behavior; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• J. Marc Rhoads, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Gastroentrologist

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: May 9, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

US (1)