Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
VSL Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00951548
First received: August 2, 2009
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention
Ulcerative Colitis
Dietary Supplement: VSL#3
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by VSL Pharmaceuticals:

Primary Outcome Measures:
  • 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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Activity of ulcerative colitis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in subjective symptoms from baseline to weeks 2, 4 and 8 of food supplementation with VSL#3 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Lack of beneficial effects, defined by need for further food supplementation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Inability to stay on study [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: October 2006
Study Completion Date: October 2008
Arms Assigned Interventions
Experimental: VSL#3
Probiotic preparation VSL#3
Dietary Supplement: VSL#3
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
Placebo Comparator: placebo
Corn Starch
Dietary Supplement: Placebo
Corn Starch. Dosage regimen is 2 sachets b.i.d. for 8 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients aged more than 18 years;
  2. Diagnosis of ulcerative colitis established by previous colonoscopy, with consistent histology and clinical course;
  3. 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;
  4. 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;
  5. Symptomatic (current episode) for less than 4 weeks;
  6. Minimum endoscopic score of 2 on the UCDAI at screening (mucosal appearance);
  7. 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;
  8. Negative pregnancy test on screening and agreeing to use valid contraception for the duration of the study;
  9. Patient not requiring hospitalisation;
  10. Willing an able to provide written informed consent

Exclusion Criteria:

  1. Crohn's disease or pouchitis;
  2. UCDAI greater than 8 (need for emergency surgery or presence of severe disease;
  3. Use of oral steroids within the last 4 weeks prior to study entry;
  4. Use of antibiotics within the last 2 weeks prior to study entry;
  5. 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;
  6. Use of rectal 5-ASA or steroids for one week before and throughout the 8 week study period;
  7. Use of probiotic preparations either prescribed or over-the-counter within 2 weeks prior to study entry;
  8. Use of NSAIDS for one week before and throughout the 8 week study period;
  9. Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the Investigator;
  10. History of severe adverse reaction or known hypersensitivity to maltose and/or silicon dioxide;
  11. Patient requiring hospitalisation;
  12. Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control (negative pregnancy test also required);
  13. Use of any investigational drug and/or participation in any clinical trial within 3 months of entry to this study;
  14. Inability to give a valid informed consent or to properly follow the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951548

Locations
Italy
U.O. di Medicina Interna Ospedaliera Policlinico di Bari
Bari, Italy, 70023
Reparto di Gastroenterologia ed Endoscopia Digestiva Azienda Ospedaliera Pugliese-Ciaccio
Catanzaro, Italy, 88100
U.O. Fisiopatologia Digestiva Azienda Ospedaliera Mater Domini Campus Universitario di Germaneto
Catanzaro, Italy, 88100
U.O. di Endoscopia Digestiva Presidio Ospedaliero San Salvatore
L'Aquila, Italy, 67100
Dipartimento di Chirurgia Generale Servizio di Endoscopia Digestiva Ospedale Santa Maria Goretti
Latina, Italy, 04100
Struttura Complessa di Medicina Interna Azienda Ospedaliera Villa Sofia - CTO Ospedale Villa Sofia
Palermo, Italy, 90146
U.O. di Nutrizione Clinica Ospedale Sant'Eugenio
Roma, Italy, 00144
Istituto di Medicina Interna CIC Columbus Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore
Roma, Italy, 00168
P.O. Nuovo Regina Margherita Unità Operativa di Endoscopia e Gastroenterologia
Roma, Italy, 00153
Unità di Endoscopia Azienda Ospedaliera Sant'Andrea
Roma, Italy, 00189
Dipartimento di Medicina Interna U.O. di Gastroenterologia ed Endoscopia Digestiva Ospedale Cristo Re
Roma, Italy, 00167
Divisione di Gastroenterologia Istituto Clinico Humanitas
Rozzano (MI), Italy, 20089
U.O.C. Endoscopia Digestiva IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo (FG), Italy, 71013
Sponsors and Collaborators
VSL Pharmaceuticals
Investigators
Study Director: Claudio De Simone, Prof. VSL Pharmaceuticals
  More Information

No publications provided

Responsible Party: Prof. Claudio De Simone, VSL Parmaceuticals
ClinicalTrials.gov Identifier: NCT00951548     History of Changes
Other Study ID Numbers: VSL-UC-03
Study First Received: August 2, 2009
Last Updated: August 3, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by VSL Pharmaceuticals:
Probiotics
VSL#3
Double-blind
Placebo controlled

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014