Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic
NCT ID: NCT00893711
Last Updated: 2021-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
155 participants
INTERVENTIONAL
2008-03-31
2022-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
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
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.
L.reuteri + vit D
L. reuteri DSM 17938 (10\^8 CFU) plus vitamin D3 (400 UI) five drops/day for 3 months
L.reuteri + Vit D
Vit D Placebo
vitamin D3 (400 UI) five drops/day for 3 months
Vit D placebo
Interventions
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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
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.
L.reuteri + Vit D
Vit D placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* gestational age between 37 and 42 weeks
* age between 4 and 16 weeks
* birth weight between 2500 and 4000 g
* exclusively breastfed
Exclusion Criteria
* administration of probiotics and antibiotics
4 Weeks
16 Weeks
ALL
No
Sponsors
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Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
OTHER
Responsible Party
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Dr. SAVINO Francesco
MD, PhD
Principal Investigators
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Francesco Savino, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Infantile Regina Margherita - Dipartimento di Pediatria.S.S.D. SAPI, Torino
Locations
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Ospedale Infantile Regina Margherita
Torino, TO, Italy
Ospedale Infantile Regina Margherita
Torino, , Italy
Ospedale Infantile Regina Margherita
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Savino F. Focus on infantile colic. Acta Paediatr. 2007 Sep;96(9):1259-64. doi: 10.1111/j.1651-2227.2007.00428.x.
Savino F, Pelle E, Castagno E, Palumeri E, Oggero R. Must infants with colic really be hospitalized? Acta Paediatr. 2007 Jul;96(7):1109; author reply 1110. doi: 10.1111/j.1651-2227.2007.00328.x. Epub 2007 May 10. No abstract available.
Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30. doi: 10.1542/peds.2006-1222.
Savino F, Grassino EC, Guidi C, Oggero R, Silvestro L, Miniero R. Ghrelin and motilin concentration in colicky infants. Acta Paediatr. 2006 Jun;95(6):738-41. doi: 10.1080/08035250500522654.
Savino F, Palumeri E, Castagno E, Cresi F, Dalmasso P, Cavallo F, Oggero R. Reduction of crying episodes owing to infantile colic: A randomized controlled study on the efficacy of a new infant formula. Eur J Clin Nutr. 2006 Nov;60(11):1304-10. doi: 10.1038/sj.ejcn.1602457. Epub 2006 May 31.
Savino F, Castagno E, Bretto R, Brondello C, Palumeri E, Oggero R. A prospective 10-year study on children who had severe infantile colic. Acta Paediatr Suppl. 2005 Oct;94(449):129-32. doi: 10.1111/j.1651-2227.2005.tb02169.x.
Savino F, Cresi F, Castagno E, Silvestro L, Oggero R. A randomized double-blind placebo-controlled trial of a standardized extract of Matricariae recutita, Foeniculum vulgare and Melissa officinalis (ColiMil) in the treatment of breastfed colicky infants. Phytother Res. 2005 Apr;19(4):335-40. doi: 10.1002/ptr.1668.
Savino F, Bailo E, Oggero R, Tullio V, Roana J, Carlone N, Cuffini AM, Silvestro L. Bacterial counts of intestinal Lactobacillus species in infants with colic. Pediatr Allergy Immunol. 2005 Feb;16(1):72-5. doi: 10.1111/j.1399-3038.2005.00207.x.
Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, Silvestro L, Oggero R. Intestinal microflora in breastfed colicky and non-colicky infants. Acta Paediatr. 2004 Jun;93(6):825-9.
Savino F, Garro M, Montanari P, Galliano I, Bergallo M. Crying Time and RORgamma/FOXP3 Expression in Lactobacillus reuteri DSM17938-Treated Infants with Colic: A Randomized Trial. J Pediatr. 2018 Jan;192:171-177.e1. doi: 10.1016/j.jpeds.2017.08.062. Epub 2017 Sep 29.
Roos S, Dicksved J, Tarasco V, Locatelli E, Ricceri F, Grandin U, Savino F. 454 pyrosequencing analysis on faecal samples from a randomized DBPC trial of colicky infants treated with Lactobacillus reuteri DSM 17938. PLoS One. 2013;8(2):e56710. doi: 10.1371/journal.pone.0056710. Epub 2013 Feb 28.
Other Identifiers
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FS-2009
Identifier Type: -
Identifier Source: org_study_id
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