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Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic

NCT00893711 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2021-03-03

No results posted yet for this study

Summary

The purpose of this study is:

* to study the intestinal microflora of colicky infants before and after L. reuteri or placebo administration, evaluating the effect of Lactobacillus reuteri on the growth of the main intestinal microbiota (coliforms, Clostridium butyricum, Lactobacilli, Bifidobacteria) with fluorescent in situ hybridization (FISH) technique or with Real-Time PCR Taqman; Further, the global intestinal microflora composition, using large-scale DNA sequencing of 16S rRNA genes ( 454-pyrosequencing technique.
* to evaluate the improvement of colicky symptoms by the oral administration of Lactobacillus reuteri (primary outcome: reduction of the daily average crying time from baseline to the end of the treatment period, to less than 3 hours a day, the cut-off proposed by Wessel; secondary outcome: number of responders versus non-responders in each group at the end of the treatment).
* to evaluate fecal calprotectin values at the beginning and at the end of the study. BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland). A quantitative immunoassay.
* to evaluate Th17/Treg balance at time 0 and t 30 ( days) investigating mRNA FOXP3 and RORγ in peripheral blood using RT-PCR Real Time Taqman.
* the measurement of the expression level of CC-chemokine receptor 7 messenger RNA using the real-time TaqMan reverse transcription polymerase chain reaction method.
* the measurement of expression of interleukin 10 (IL-10) messenger RNA using the real-time TaqMan reverse transcription polymerase chain reaction method.
* Parental satisfaction at the end of the study period ( 30 day ) with a numerc scale from 1 to 10.

Conditions

  • Infantile Colic

Interventions

OTHER

Lactobacillus reuteri DSM 17938

Lactobacillus reuteri is administered at a dose of 1.000.000.000 colony forming units (CFU) in V drops/day for 21 days

OTHER

Placebo

Placebo is administered in V drops once a day for 21 days. Placebo is inactive, similar to the studied treatment with the same package, taste, characteristics of colour and consistency.

DIETARY_SUPPLEMENT

L.reuteri + Vit D

DIETARY_SUPPLEMENT

Vit D placebo

Sponsors & Collaborators

  • Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

    lead OTHER

Principal Investigators

  • Francesco Savino, MD, PhD · Ospedale Infantile Regina Margherita - Dipartimento di Pediatria.S.S.D. SAPI, Torino

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2021-11-30
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00893711 on ClinicalTrials.gov