Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic: a Clinical and Microbiological, Double-blind, Prospective, Randomised, Controlled ... View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2008-2018

ABSTRACT

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. Detailed Description Infantile colic is one of the most common problems within the first three months of life. It consists of a behavioural syndrome characterised by paroxysmal, excessive and inconsolable crying without identifiable cause. Although infantile colic is commonly reported and causes appreciable distress for both parents and paediatricians, despite forty years of research, its aetiology still remains unclear. Recently the role of intestinal microflora has growing importance, and a lower count of intestinal lactobacilli has been observed in colicky infants compared to healthy ones. In a recent study we have observed that Lactobacillus reuteri improved colicky symptoms in breast-fed infants within one week of treatment compared to Simethicone, suggesting that probiotics may play a role in infantile colic (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; 119:e124-30). The mechanism involved in such finding is only partially understood and, for this reason, we have planned this new study to evaluate not only the clinical improvement but also the microbiological data. More... »

URL

https://clinicaltrials.gov/show/NCT00893711

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3053", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }
    ], 
    "description": "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. B\u00dcHLMANN Quantum Blue\u00ae Calprotectin High Range (Sch\u00f6nenbuch, Switzerland). A quantitative immunoassay. - to evaluate Th17/Treg balance at time 0 and t 30 ( days) investigating mRNA FOXP3 and ROR\u03b3 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.\n\nDetailed Description\nInfantile colic is one of the most common problems within the first three months of life. It consists of a behavioural syndrome characterised by paroxysmal, excessive and inconsolable crying without identifiable cause. Although infantile colic is commonly reported and causes appreciable distress for both parents and paediatricians, despite forty years of research, its aetiology still remains unclear. Recently the role of intestinal microflora has growing importance, and a lower count of intestinal lactobacilli has been observed in colicky infants compared to healthy ones. In a recent study we have observed that Lactobacillus reuteri improved colicky symptoms in breast-fed infants within one week of treatment compared to Simethicone, suggesting that probiotics may play a role in infantile colic (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; 119:e124-30). The mechanism involved in such finding is only partially understood and, for this reason, we have planned this new study to evaluate not only the clinical improvement but also the microbiological data.", 
    "endDate": "2018-04-01T00:00:00Z", 
    "id": "sg:clinicaltrial.NCT00893711", 
    "keywords": [
      "lactobacillus", 
      "prevention", 
      "Double-Blind", 
      "controlled study", 
      "intestinal microflora", 
      "infant", 
      "L. reuteri", 
      "placebo administration", 
      "intestinal microbiota", 
      "Clostridium", 
      "situ hybridization", 
      "fluorescence in situ hybridization", 
      "technique", 
      "real time", 
      "large-scale DNA sequencing", 
      "rRNA gene", 
      "pyrosequencing", 
      "improvement", 
      "symptom", 
      "oral administration", 
      "primary outcome", 
      "reduction", 
      "average", 
      "baseline", 
      "treatment period", 
      "Secondary outcome", 
      "responder", 
      "non-responders", 
      "beginning", 
      "quantum", 
      "high range", 
      "Switzerland", 
      "quantitative immunoassay", 
      "balance", 
      "time 0", 
      "Foxp3", 
      "peripheral blood", 
      "study period", 
      "scale", 
      "infantile", 
      "common problem", 
      "life", 
      "behavioral syndrome", 
      "distress", 
      "parent", 
      "pediatrician", 
      "etiology", 
      "count", 
      "healthy one", 
      "Recent study", 
      "breast-fed infant", 
      "probiotic", 
      "American Type Culture Collection", 
      "randomized study", 
      "clinical improvement"
    ], 
    "name": "Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic: a Clinical and Microbiological, Double-blind, Prospective, Randomised, Controlled Study", 
    "sameAs": [
      "https://app.dimensions.ai/details/clinical_trial/NCT00893711"
    ], 
    "sdDataset": "clinical_trials", 
    "sdDatePublished": "2019-03-07T15:23", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "file:///pack/app/us_ct_data_00007.json", 
    "sponsor": [
      {
        "id": "https://www.grid.ac/institutes/grid.415778.8", 
        "type": "Organization"
      }
    ], 
    "startDate": "2008-03-01T00:00:00Z", 
    "subjectOf": [
      {
        "id": "https://doi.org/10.1111/j.1651-2227.2005.tb02169.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1006685273"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1651-2227.2004.tb03025.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1014181298"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1651-2227.2007.00428.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1020105507"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1399-3038.2005.00207.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1027792526"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1371/journal.pone.0056710", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1029809315"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1651-2227.2006.tb02324.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1031035285"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/sj.ejcn.1602457", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040874564", 
          "https://doi.org/10.1038/sj.ejcn.1602457"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/ptr.1668", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1050082276"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1651-2227.2007.00328.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1051776925"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1542/peds.2006-1222", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1067825361"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jpeds.2017.08.062", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1091985180"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "type": "MedicalStudy", 
    "url": "https://clinicaltrials.gov/show/NCT00893711"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/clinicaltrial.NCT00893711'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT00893711'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT00893711'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT00893711'


 

This table displays all metadata directly associated to this object as RDF triples.

108 TRIPLES      16 PREDICATES      81 URIs      64 LITERALS      1 BLANK NODES

Subject Predicate Object
1 sg:clinicaltrial.NCT00893711 schema:about anzsrc-for:3053
2 schema:description 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. Detailed Description Infantile colic is one of the most common problems within the first three months of life. It consists of a behavioural syndrome characterised by paroxysmal, excessive and inconsolable crying without identifiable cause. Although infantile colic is commonly reported and causes appreciable distress for both parents and paediatricians, despite forty years of research, its aetiology still remains unclear. Recently the role of intestinal microflora has growing importance, and a lower count of intestinal lactobacilli has been observed in colicky infants compared to healthy ones. In a recent study we have observed that Lactobacillus reuteri improved colicky symptoms in breast-fed infants within one week of treatment compared to Simethicone, suggesting that probiotics may play a role in infantile colic (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; 119:e124-30). The mechanism involved in such finding is only partially understood and, for this reason, we have planned this new study to evaluate not only the clinical improvement but also the microbiological data.
3 schema:endDate 2018-04-01T00:00:00Z
4 schema:keywords American Type Culture Collection
5 Clostridium
6 Double-Blind
7 Foxp3
8 L. reuteri
9 Recent study
10 Secondary outcome
11 Switzerland
12 average
13 balance
14 baseline
15 beginning
16 behavioral syndrome
17 breast-fed infant
18 clinical improvement
19 common problem
20 controlled study
21 count
22 distress
23 etiology
24 fluorescence in situ hybridization
25 healthy one
26 high range
27 improvement
28 infant
29 infantile
30 intestinal microbiota
31 intestinal microflora
32 lactobacillus
33 large-scale DNA sequencing
34 life
35 non-responders
36 oral administration
37 parent
38 pediatrician
39 peripheral blood
40 placebo administration
41 prevention
42 primary outcome
43 probiotic
44 pyrosequencing
45 quantitative immunoassay
46 quantum
47 rRNA gene
48 randomized study
49 real time
50 reduction
51 responder
52 scale
53 situ hybridization
54 study period
55 symptom
56 technique
57 time 0
58 treatment period
59 schema:name Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic: a Clinical and Microbiological, Double-blind, Prospective, Randomised, Controlled Study
60 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT00893711
61 schema:sdDatePublished 2019-03-07T15:23
62 schema:sdLicense https://scigraph.springernature.com/explorer/license/
63 schema:sdPublisher N586b1b7c94be4cb18e837aa4e83e8086
64 schema:sponsor https://www.grid.ac/institutes/grid.415778.8
65 schema:startDate 2008-03-01T00:00:00Z
66 schema:subjectOf sg:pub.10.1038/sj.ejcn.1602457
67 https://doi.org/10.1002/ptr.1668
68 https://doi.org/10.1016/j.jpeds.2017.08.062
69 https://doi.org/10.1111/j.1399-3038.2005.00207.x
70 https://doi.org/10.1111/j.1651-2227.2004.tb03025.x
71 https://doi.org/10.1111/j.1651-2227.2005.tb02169.x
72 https://doi.org/10.1111/j.1651-2227.2006.tb02324.x
73 https://doi.org/10.1111/j.1651-2227.2007.00328.x
74 https://doi.org/10.1111/j.1651-2227.2007.00428.x
75 https://doi.org/10.1371/journal.pone.0056710
76 https://doi.org/10.1542/peds.2006-1222
77 schema:url https://clinicaltrials.gov/show/NCT00893711
78 sgo:license sg:explorer/license/
79 sgo:sdDataset clinical_trials
80 rdf:type schema:MedicalStudy
81 N586b1b7c94be4cb18e837aa4e83e8086 schema:name Springer Nature - SN SciGraph project
82 rdf:type schema:Organization
83 anzsrc-for:3053 schema:inDefinedTermSet anzsrc-for:
84 rdf:type schema:DefinedTerm
85 sg:pub.10.1038/sj.ejcn.1602457 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040874564
86 https://doi.org/10.1038/sj.ejcn.1602457
87 rdf:type schema:CreativeWork
88 https://doi.org/10.1002/ptr.1668 schema:sameAs https://app.dimensions.ai/details/publication/pub.1050082276
89 rdf:type schema:CreativeWork
90 https://doi.org/10.1016/j.jpeds.2017.08.062 schema:sameAs https://app.dimensions.ai/details/publication/pub.1091985180
91 rdf:type schema:CreativeWork
92 https://doi.org/10.1111/j.1399-3038.2005.00207.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1027792526
93 rdf:type schema:CreativeWork
94 https://doi.org/10.1111/j.1651-2227.2004.tb03025.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1014181298
95 rdf:type schema:CreativeWork
96 https://doi.org/10.1111/j.1651-2227.2005.tb02169.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1006685273
97 rdf:type schema:CreativeWork
98 https://doi.org/10.1111/j.1651-2227.2006.tb02324.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1031035285
99 rdf:type schema:CreativeWork
100 https://doi.org/10.1111/j.1651-2227.2007.00328.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1051776925
101 rdf:type schema:CreativeWork
102 https://doi.org/10.1111/j.1651-2227.2007.00428.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1020105507
103 rdf:type schema:CreativeWork
104 https://doi.org/10.1371/journal.pone.0056710 schema:sameAs https://app.dimensions.ai/details/publication/pub.1029809315
105 rdf:type schema:CreativeWork
106 https://doi.org/10.1542/peds.2006-1222 schema:sameAs https://app.dimensions.ai/details/publication/pub.1067825361
107 rdf:type schema:CreativeWork
108 https://www.grid.ac/institutes/grid.415778.8 schema:Organization
 




Preview window. Press ESC to close (or click here)


...