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A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lactobacillus reuteri | Experimental | 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. |
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| placebo | Placebo Comparator | a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lactobacillus reuteri | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The increase of BMs/week frequency | January to June 2012 (up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| the improvement of stool consistency | january to june 2012 (up to 6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| veronica ojetti | catholic university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University Sacred Heart | Rome | Italy/rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20542295 | Background | 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. | |
| 25531996 | Derived |
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| placebo | Drug | a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks |
|
| 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. |