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Lactobacillus Reuteri in Adult With Functional Chronic Constipation

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ClinicalTrials.gov Identifier: NCT01870700
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
veronica ojetti, Catholic University, Italy

Brief Summary:
A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.

Condition or disease Intervention/treatment Phase
Functional Constipation Drug: lactobacillus reuteri Drug: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Lactobacillus Reuteri Supplementation to Adult With Functional Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial
Study Start Date : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: lactobacillus reuteri
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.
Drug: lactobacillus reuteri
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
Other Name: Reuflor

Placebo Comparator: placebo
a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
Drug: placebo
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 Measures :
  1. The increase of BMs/week frequency [ Time Frame: January to June 2012 (up to 6 months) ]

Secondary Outcome Measures :
  1. the improvement of stool consistency [ Time Frame: january to june 2012 (up to 6 months) ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870700


Locations
Italy
Catholic University Sacred Heart
Rome, Italy/rome, Italy, 00168
Sponsors and Collaborators
Catholic University, Italy
Investigators
Study Chair: veronica ojetti catholic university