Back to resultsLactobacillus Reuteri in Adult With Functional Chronic Constipation
Primary Purpose
Functional Constipation
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
lactobacillus reuteri
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Functional Constipation
Eligibility Criteria
Inclusion Criteria:
- functional constipation rome III
Exclusion Criteria:
- hypothyroidism or other metabolic or renal abnormalities, or
- antibiotic's treatment,
- probiotic or prebiotic supplementation in the last month
Sites / Locations
- Catholic University Sacred Heart
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
lactobacillus reuteri
placebo
Arm Description
Intervention: supplementation with the probiotic Lactobacillus reuteri (DSM 17938),Reuflor, was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks.
a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
Outcomes
Primary Outcome Measures
The increase of BMs/week frequency
Secondary Outcome Measures
the improvement of stool consistency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01870700
Brief Title
Lactobacillus Reuteri in Adult With Functional Chronic Constipation
Official Title
The Effect of Lactobacillus Reuteri Supplementation to Adult With Functional Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.
Detailed Description
Patients affected by functional constipation according to Rome III criteria. The increase of Bowel Movements/week frequency was the primary outcome, while the improvement of stool consistency was the secondary outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lactobacillus reuteri
Arm Type
Experimental
Arm Description
Intervention: supplementation with the probiotic Lactobacillus reuteri (DSM 17938),Reuflor, was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
lactobacillus reuteri
Other Intervention Name(s)
Reuflor
Intervention Description
Lactobacillus reuteri (DSM 17938) was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
Primary Outcome Measure Information:
Title
The increase of BMs/week frequency
Time Frame
January to June 2012 (up to 6 months)
Secondary Outcome Measure Information:
Title
the improvement of stool consistency
Time Frame
january to june 2012 (up to 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
functional constipation rome III
Exclusion Criteria:
hypothyroidism or other metabolic or renal abnormalities, or
antibiotic's treatment,
probiotic or prebiotic supplementation in the last month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
veronica ojetti
Organizational Affiliation
catholic university
Official's Role
Study Chair
Facility Information:
Facility Name
Catholic University Sacred Heart
City
Rome
State/Province
Italy/rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
20542295
Citation
Coccorullo P, Strisciuglio C, Martinelli M, Miele E, Greco L, Staiano A. Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. J Pediatr. 2010 Oct;157(4):598-602. doi: 10.1016/j.jpeds.2010.04.066. Epub 2010 Jun 12.
Results Reference
background
PubMed Identifier
25531996
Citation
Ojetti V, Ianiro G, Tortora A, D'Angelo G, Di Rienzo TA, Bibbo S, Migneco A, Gasbarrini A. The effect of Lactobacillus reuteri supplementation in adults with chronic functional constipation: a randomized, double-blind, placebo-controlled trial. J Gastrointestin Liver Dis. 2014 Dec;23(4):387-91. doi: 10.15403/jgld.2014.1121.234.elr.
Results Reference
derived
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Lactobacillus Reuteri in Adult With Functional Chronic Constipation
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