NCT00951548

Brief Summary

This is a double-blind, randomized, placebo controlled study to assess the beneficial effects of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in patients affected by mild to moderate active ulcerative colitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

First QC Date

August 2, 2009

Last Update Submit

August 3, 2009

Conditions

Ulcerative Colitis

Keywords

ProbioticsVSL#3Double-blindPlacebo controlled

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the evaluation of the beneficial effects of food supplementation with VSL#3 in patients affected by UC, assessed by a decrease in the UCDAI of 50% or more

    8 weeks

Secondary Outcomes (4)

  • Activity of ulcerative colitis

    8 weeks

  • Change in subjective symptoms from baseline to weeks 2, 4 and 8 of food supplementation with VSL#3

    8 weeks

  • Lack of beneficial effects, defined by need for further food supplementation

    8 weeks

  • Inability to stay on study

    8 weeks

Study Arms (2)

VSL#3

EXPERIMENTAL

Probiotic preparation VSL#3

Dietary Supplement: VSL#3

placebo

PLACEBO COMPARATOR

Corn Starch

Dietary Supplement: Placebo

Interventions

VSL#3DIETARY_SUPPLEMENT

Probiotic blend of 8 different strains of lactobacilli and bifidobacteria, dosed at 900 billion bacteria/sachet). Dosage regimen is 2 sachets b.i.d. for 8 weeks

VSL#3
PlaceboDIETARY_SUPPLEMENT

Corn Starch. Dosage regimen is 2 sachets b.i.d. for 8 weeks

placebo

Eligibility Criteria

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

You may qualify if:

  • Male and female patients aged more than 18 years;
  • Diagnosis of ulcerative colitis established by previous colonoscopy, with consistent histology and clinical course;
  • Ulcerative colitis extending for more than 15 cm from the anal verge, that is involving at least the rectosigmoid. This is based on colonoscopy at any time since the onset of ulcerative colitis. Activity (not extent) must be confirmed by colonoscopy at the beginning of the study;
  • Mild to moderate active ulcerative colitis. Patients must have a minimum score of 3 and a maximum score of 8 on the 12 point UCDAI (Ulcerative Colitis Disease Activity Index - see Appendix 3) that measures stool frequency, rectal bleeding, endoscopic findings and physician's overall assessment of disease severity;
  • Symptomatic (current episode) for less than 4 weeks;
  • Minimum endoscopic score of 2 on the UCDAI at screening (mucosal appearance);
  • Use of oral 5-ASA at least 4 weeks prior to study entry, at same dose; and/or use of Azathioprine or 6-mercaptopurine at least 3 months prior to study entry, at same dose;
  • Negative pregnancy test on screening and agreeing to use valid contraception for the duration of the study;
  • Patient not requiring hospitalisation;
  • Willing an able to provide written informed consent

You may not qualify if:

  • Crohn's disease or pouchitis;
  • UCDAI greater than 8 (need for emergency surgery or presence of severe disease;
  • Use of oral steroids within the last 4 weeks prior to study entry;
  • Use of antibiotics within the last 2 weeks prior to study entry;
  • Change in dose of oral 5-ASA within the last 4 weeks prior to study entry and throughout the 8 week study period, or change in dose of oral 6-mercaptopurine and azathioprine drugs within the last 3 months prior to study entry and throughout the 8 week study period;
  • Use of rectal 5-ASA or steroids for one week before and throughout the 8 week study period;
  • Use of probiotic preparations either prescribed or over-the-counter within 2 weeks prior to study entry;
  • Use of NSAIDS for one week before and throughout the 8 week study period;
  • Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the Investigator;
  • History of severe adverse reaction or known hypersensitivity to maltose and/or silicon dioxide;
  • Patient requiring hospitalisation;
  • Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control (negative pregnancy test also required);
  • Use of any investigational drug and/or participation in any clinical trial within 3 months of entry to this study;
  • Inability to give a valid informed consent or to properly follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

U.O. di Medicina Interna Ospedaliera Policlinico di Bari

Bari, 70023, Italy

Location

Reparto di Gastroenterologia ed Endoscopia Digestiva Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, 88100, Italy

Location

U.O. Fisiopatologia Digestiva Azienda Ospedaliera Mater Domini Campus Universitario di Germaneto

Catanzaro, 88100, Italy

Location

Dipartimento di Chirurgia Generale Servizio di Endoscopia Digestiva Ospedale Santa Maria Goretti

Latina, 04100, Italy

Location

U.O. di Endoscopia Digestiva Presidio Ospedaliero San Salvatore

L’Aquila, 67100, Italy

Location

Struttura Complessa di Medicina Interna Azienda Ospedaliera Villa Sofia - CTO Ospedale Villa Sofia

Palermo, 90146, Italy

Location

U.O. di Nutrizione Clinica Ospedale Sant'Eugenio

Roma, 00144, Italy

Location

P.O. Nuovo Regina Margherita Unità Operativa di Endoscopia e Gastroenterologia

Roma, 00153, Italy

Location

Dipartimento di Medicina Interna U.O. di Gastroenterologia ed Endoscopia Digestiva Ospedale Cristo Re

Roma, 00167, Italy

Location

Istituto di Medicina Interna CIC Columbus Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

Unità di Endoscopia Azienda Ospedaliera Sant'Andrea

Roma, 00189, Italy

Location

Divisione di Gastroenterologia Istituto Clinico Humanitas

Rozzano (MI), 20089, Italy

Location

U.O.C. Endoscopia Digestiva IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo (FG), 71013, Italy

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Claudio De Simone, Prof.

    VSL Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2009

First Posted

August 4, 2009

Study Start

October 1, 2006

Study Completion

October 1, 2008

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

IT(13)