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NCT Number: NCT01849991

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

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.

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Key information

Conditions

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

Age range

3 week–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Placebo

Biological

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

Primary outcomes

  1. 45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status.

    Time frame: 92 days

    • Physical Examination of infants will be performed to evaluate any adverse effects of LR.
    • 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.

Secondary outcomes

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

    Time frame: 1, 42 & 92 days

    To examine for evidence of anti-inflammatory effects in the normal intestine, we will test fecal samples from all infants for calprotectin level.

Other outcomes

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

    Time frame: 92 days

    Clinical scoring of crying and fussing will be evaluated using the Barr diary which will show crying patterns.

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

    Time frame: 1& 42 days

    • A panel of inflammatory biomarkers will be examined which includes Th1 cytokines (TNFα, IL-1β); a Th2 cytokine (IL-10), a cytokine which regulates maturation of Tregs (IL-2), a cytokine receptor (OPG), a marker of intestinal barrier function (TIMP-1) and a marker for autoimmunity (TWEAK). Biomarkers will be assessed by MSD human multiplex cytokine assays or R&D Human ELISA kit.
    • We will determine if LR treatment affects the frequency of Tregs in PBMCs in normal babies with colic.

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

    Time frame: 1, 42 & 92 days

    A stool sample will be collected and analyzed to determine the effect on overall microbiota produced by the ingestion of LR.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 9, 2013
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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