NCT01737983

Brief Summary

The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2009

Typical duration for phase_4

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

May 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

July 12, 2012

Last Update Submit

November 28, 2012

Conditions

CYSTIC FIBROSIS

Keywords

cystic fibrosisprobioticsLactobacillus reuteri

Outcome Measures

Primary Outcomes (4)

  • Efficacy

    Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.

    6 months of observation

  • Efficacy

    Evaluate number of hospital admissions required for pulmonary exacerbations in the two groups.

    6 months of observation

  • efficacy

    Evaluate number of gastrointestinal and upper respiratory tract infections.

    6 months of observation

  • efficacy

    Evaluate duration of hospital admissions required for pulmonary exacerbations in the two groups.

    6 months of observation

Secondary Outcomes (5)

  • efficacy

    6 months of observation

  • efficacy

    6 months of observation

  • efficacy

    6 months of observation

  • efficacy

    6 months of observation

  • efficacy

    6 months of observation

Study Arms (2)

Lactobacillus reuteri (LR) ATCC55730

EXPERIMENTAL

The tested probiotic, Lactobacillus reuteri, was administered in 5 drops per day (10\^10 colony-forming units) for 6 months

Dietary Supplement: Lactobacillus reuteri

placebo

PLACEBO COMPARATOR

The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation for 6 months During the test period, patients were not allowed to consume any other product that contained probiotics or prebiotics

Dietary Supplement: placebo

Interventions

Lactobacillus reuteriDIETARY_SUPPLEMENT

Lactobacillus reuteri was administered in 5 drops per day (10\^10 colony-forming units) for 6 months.

Also known as: (LR) ATCC55730
Lactobacillus reuteri (LR) ATCC55730
placeboDIETARY_SUPPLEMENT

The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation, was administered in 5 drops per day

placebo

Eligibility Criteria

Age6 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Forced expiratory volume in the 1st second (FEV1) \> 70%.
  • No inhaled or systemic steroids.
  • No anti-inflammatory drugs, antileukotrienes and mast cell membrane stabilizers.
  • No serious organ involvement.

You may not qualify if:

  • History of pulmonary exacerbation or upper respiratory infection in the previous two months.
  • Changes in medications in the past two months.
  • History of hemoptysis in the past two months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"

Roma, 00161, Italy

Location

Related Publications (1)

  • Di Nardo G, Oliva S, Menichella A, Pistelli R, De Biase RV, Patriarchi F, Cucchiara S, Stronati L. Lactobacillus reuteri ATCC55730 in cystic fibrosis. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):81-6. doi: 10.1097/MPG.0000000000000187.

    PMID: 24121143DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 12, 2012

First Posted

November 30, 2012

Study Start

May 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations

IT(1)