Lactobacillus Reuteri in Adult With Functional Chronic Constipation

Functional Constipation Clinical Trial

Official title:

The Effect of Lactobacillus Reuteri Supplementation to Adult With Functional Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870700
• Other study ID #: no one
• Status: Completed
• Phase: Phase 3
• First received: May 25, 2013
• Last updated: June 4, 2013
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: June 2013
• Source: Catholic University, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

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
• placebo
a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks

Locations

Country	Name	City	State
Italy	Catholic University Sacred Heart	Rome	Italy/rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The increase of BMs/week frequency		January to June 2012 (up to 6 months)	No
Secondary	the improvement of stool consistency		january to june 2012 (up to 6 months)	No