Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic
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|ClinicalTrials.gov Identifier: NCT00893711|
Recruitment Status : Recruiting
First Posted : May 6, 2009
Last Update Posted : April 5, 2017
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.
- Parental satisfaction at the end of the study period ( 30 day ) with a numerc scale from 1 to 10.
|Condition or disease||Intervention/treatment|
|Infantile Colic||Other: Lactobacillus reuteri DSM 17938 Other: Placebo Dietary Supplement: L.reuteri + Vit D Dietary Supplement: Vit D placebo|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||155 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic: a Clinical and Microbiological, Double-blind, Prospective, Randomised, Controlled Study|
|Study Start Date :||March 2008|
|Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||November 2017|
Active Comparator: Lactobacillus reuteri
Lactobacillus reuteri DSM 17938 is administered at a dose of 1.000.000.000 colony forming units (CFU) in V drops of a commercially available oil suspension, 30 min before feeding, once a day for 30 days.
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 Name: Reuterin, BIOGAIA - Sweden
Placebo Comparator: Placebo
Placebo is administered in V drops once a day for 30 days. Placebo is inactive, similar to the studied treatment with the same package, taste, characteristics of colour and consistency.
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.
Other Name: Placebo BIOGAIA Sweden
Active Comparator: L.reuteri + vit D
L. reuteri DSM 17938 (10^8 CFU) plus vitamin D3 (400 UI) five drops/day for 3 months
Dietary Supplement: L.reuteri + Vit D
Placebo Comparator: Vit D Placebo
vitamin D3 (400 UI) five drops/day for 3 months
|Dietary Supplement: Vit D placebo|
- 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 and number of responders versus non-responders in each group at the end of the treatment [ Time Frame: time 0 - 7 - 21 - 30 days ]diary crying Barr
- Responders to treatment [ Time Frame: 30 day ]was defined as the number of responders in each group on days 7, 14 , 21 and 30 . Responders (defined in the protocol) were those who experienced a decrease in the daily average crying time of 50% from baseline. Diary Crying Barr.
- To analyze intestinal microflora [ Time Frame: day 0 and day 30 ]The intestinal microflora of the infants will be analyzed the effect of the probiotic on selected intestinal microbiota (Escherichia coli, Clostridium butyricum, Lactobacillus, Bifidobacterium), using fluorescent in situ hybridization (FISH) or using with Real-Time PCR Taqman.
- Assay of Th17/Treg balance [ Time Frame: time 0- 30 days ]For the analyses of mRNA FOXP3 and RORγ in peripheral blood RT-PCR Real Time Taqman will be used
- Preventive effects of L.reuteri on infantile colic [ Time Frame: 5 months ]action on: use of pain relieving agents, switch to infant formula, number of paediatric consultations for infantile colic
- Fecal calprotectin values [ Time Frame: 0-30 days ]BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland). It is a quantitative determination of fecal calprotectin through a sandwich immunoassay.
- Parental satisfacion [ Time Frame: day 30 ]numeric scale from 1to 10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893711
|Contact: Francesco Savino, MD, PhDemail@example.com|
|Ospedale Infantile Regina Margherita||Completed|
|Piazza polonia 94 - Torino, Torino, Italy, 10126|
|Ospedale Infantile Regina Margherita||Recruiting|
|Torino, TO, Italy, 10126|
|Contact: Francesco Savino, MD PhD +39 0113135618 firstname.lastname@example.org|
|Principal Investigator: Francesco Savino, MD PhD|
|Ospedale Infantile Regina Margherita||Recruiting|
|Torino, Italy, 10126|
|Contact: Francesco Savino, MD, PhD +390113135618 email@example.com|
|Principal Investigator: Francesco Savino, MD, PhD|
|Sub-Investigator: Maria Garrro, MD|
|Sub-Investigator: Massimiliano Bergallo, BS|
|Principal Investigator:||Francesco Savino, MD, PhD||Ospedale Infantile Regina Margherita - Dipartimento di Pediatria Generale e Specialistica. S.S. D. Sub Intensiva Allargata della Prima Infanzia|