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Sponsored by: |
Ospedale Infantile Regina Margherita |
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Information provided by: | Ospedale Infantile Regina Margherita |
ClinicalTrials.gov Identifier: | NCT00893711 |
The purpose of this study is:
Condition | Intervention | Phase |
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Infantile Colic Infantile Functional Gastrointestinal Disorders |
Other: Lactobacillus reuteri DSM 17938 Other: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Lactobacillus Reuteri Versus Placebo in the Treatment of Infantile Colic: a Clinical and Microbiological, Double-Blind, Prospective, Randomised, Controlled Study |
Estimated Enrollment: | 50 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Lactobacillus reuteri: Active Comparator
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 21 days.
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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
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Placebo: Placebo Comparator
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.
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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.
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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.
Ages Eligible for Study: | up to 16 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Francesco Savino, MD, PhD | 00390113135618 | francesco.savino@unito.it |
Italy, Torino | |
Ospedale Infantile Regina Margherita | Recruiting |
Piazza polonia 94 - Torino, Torino, Italy, 10126 | |
Contact: Valentina Tarasco, MD 00390113135257 valentina.tarasco@libero.it | |
Sub-Investigator: Valentina Tarasco, MD | |
Sub-Investigator: Elisabetta Palumeri, MD | |
Sub-Investigator: Emanuela Locatelli, MD | |
Sub-Investigator: Diego Matteuzzi, Professor | |
Sub-Investigator: Lisa Cordisco, PhD | |
Sub-Investigator: Roberto Oggero, MD | |
Sub-Investigator: Emanuele Castagno, MD | |
Sub-Investigator: Roberto Calabrese, PhD |
Principal Investigator: | Francesco Savino, MD, PhD | Ospedale Infantile Regina Margherita - Dipartimento di scienze Pediatriche e dell'Adolescenza |
Responsible Party: | Ospedale Infantile Regina Margherita - Dipartimento di Scienze Pediatriche ( Savino Francesco MD PhD ) |
Study ID Numbers: | FS-2009 |
Study First Received: | May 5, 2009 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00893711 History of Changes |
Health Authority: | Italy: Ethics Committee |
infantile colic lactobacillus gut microflora FISH |
Signs and Symptoms Digestive System Diseases Signs and Symptoms, Digestive Abdominal Pain |
Gastrointestinal Diseases Colic Pain |
Signs and Symptoms Digestive System Diseases Signs and Symptoms, Digestive Abdominal Pain |
Gastrointestinal Diseases Colic Pain |