NCT01870700

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

May 25, 2013

Last Update Submit

June 4, 2013

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

  • The increase of BMs/week frequency

    January to June 2012 (up to 6 months)

Secondary Outcomes (1)

  • the improvement of stool consistency

    january to june 2012 (up to 6 months)

Study Arms (2)

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.

Drug: lactobacillus reuteri

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

Drug: placebo

Interventions

lactobacillus reuteriDRUG

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

Also known as: Reuflor
lactobacillus reuteri
placeboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • functional constipation rome III

You may not qualify if:

  • hypothyroidism or other metabolic or renal abnormalities, or
  • antibiotic's treatment,
  • probiotic or prebiotic supplementation in the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University Sacred Heart

Rome, Italy/rome, 00168, Italy

Location

Related Publications (2)

  • 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.

    PMID: 20542295BACKGROUND

  • 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.

    PMID: 25531996DERIVED

Study Officials

  • veronica ojetti

    catholic university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
adjunt professor

Study Record Dates

First Submitted

May 25, 2013

First Posted

June 6, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

IT(1)