NCT00971711

Brief Summary

Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

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

September 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

4.3 years

First QC Date

September 2, 2009

Last Update Submit

March 4, 2016

Conditions

Irritable Bowel Syndrome

Keywords

IBSirritable bowel syndromeabdominal painurgencybloatingdiarrhea

Outcome Measures

Primary Outcomes (1)

  • Safety

    Daily for 4 or 8 weeks of treatment and 1 month after treatment

Secondary Outcomes (1)

  • Pain and Stooling Improvement

    4 or 8 weeks of treatment and 1 month after treatment

Study Arms (1)

Probiotic

EXPERIMENTAL

To determine the safety and effectiveness of the probiotic VSL#3 in adults with irritable bowel syndrome (IBS).

Biological: Probiotic

Interventions

ProbioticBIOLOGICAL

The subjects will be randomized into either a 4 week or 8 week treatment period with the probiotic. The treatment will be open label. They will take 2 packets once daily.

Also known as: VSL#3
Probiotic

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Otherwise well and meet the criteria for IBS as defined by the Rome III criteria
  • Ability to speak and understand English
  • Telephone access
  • IBS Severity Scale score of \>= 75

You may not qualify if:

  • Organic disease accounting for GI symptoms.
  • Chronic illness such as renal disease, congenital heart disease, diabetes, moderate or severe asthma, abdominal surgery, or immunosuppressed (e.g., organ transplant recipient).
  • Have received extraneous probiotic (i.e., not in a food such as yogurt) within 4 months of starting the study.
  • Subjects who are taking prescription or over-the-counter medications for GI disorders that completely relieve their symptoms because by definition these individuals do not have IBS (e.g., antacids, proton pump inhibitors, histamine receptor antagonists).
  • Medication allergies or contraindications which would preclude antimicrobial treatment for potential infection with VSL#3 component organisms.
  • Pregnancy.
  • Subjects who have an individual in the household who is immunosuppressed (e.g., genetic immune disorder, organ transplant).
  • Oral temperature \> 38.0 degrees Celsius.
  • Poorly controlled hypertension, history of cardiac disease, stroke/cerebral vascular accident, bowel ischemia, or other risk factors for bowel ischemia.
  • History of acute or chronic pancreatitis
  • Cardiac valvular disease or other risk factor for endocarditis
  • Subjects who indicate on the IBS scoring questionnaire that their pain is "severe" or "very severe."
  • Subjects who pain lasts more than 5 out of 10 days.
  • Subjects whose scores indicate more than mild IBS who are over 45 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor Clinic

Houston, Texas, 77030, United States

Location

Univerisity of Washington

Seattle, Washington, United States

Location

Related Publications (11)

  • Shulman RJ, Eakin MN, Jarrett M, Czyzewski DI, Zeltzer LK. Characteristics of pain and stooling in children with recurrent abdominal pain. J Pediatr Gastroenterol Nutr. 2007 Feb;44(2):203-8. doi: 10.1097/01.mpg.0000243437.39710.c0.

    PMID: 17255832BACKGROUND

  • Thakkar K, Gilger MA, Shulman RJ, El Serag HB. EGD in children with abdominal pain: a systematic review. Am J Gastroenterol. 2007 Mar;102(3):654-61. doi: 10.1111/j.1572-0241.2007.01051.x.

    PMID: 17222318BACKGROUND

  • Czyzewski DI, Eakin MN, Lane MM, Jarrett M, Shulman RJ, M D. Recurrent Abdominal Pain in Primary and Tertiary Care: Differences and Similarities. Child Health Care. 2007 May 2;36(2):137-153. doi: 10.1080/02739610701334970. No abstract available.

    PMID: 20357915BACKGROUND

  • Lane MM, Weidler EM, Czyzewski DI, Shulman RJ. Pain symptoms and stooling patterns do not drive diagnostic costs for children with functional abdominal pain and irritable bowel syndrome in primary or tertiary care. Pediatrics. 2009 Mar;123(3):758-64. doi: 10.1542/peds.2008-0227.

    PMID: 19254999BACKGROUND

  • Jarrett M, Heitkemper M, Czyzewski DI, Shulman R. Recurrent abdominal pain in children: forerunner to adult irritable bowel syndrome? J Spec Pediatr Nurs. 2003 Jul-Sep;8(3):81-9. doi: 10.1111/j.1088-145x.2003.00081.x.

    PMID: 12942886BACKGROUND

  • Burr RL, Motzer SA, Chen W, Cowan MJ, Shulman RJ, Heitkemper MM. Heart rate variability and 24-hour minimum heart rate. Biol Res Nurs. 2006 Apr;7(4):256-67. doi: 10.1177/1099800405285268.

    PMID: 16581896BACKGROUND

  • McOmber ME, Shulman RJ. Recurrent abdominal pain and irritable bowel syndrome in children. Curr Opin Pediatr. 2007 Oct;19(5):581-5. doi: 10.1097/MOP.0b013e3282bf6ddc.

    PMID: 17885479BACKGROUND

  • Kellermayer R, Tatevian N, Klish W, Shulman RJ. Steroid responsive eosinophilic gastric outlet obstruction in a child. World J Gastroenterol. 2008 Apr 14;14(14):2270-1. doi: 10.3748/wjg.14.2270.

    PMID: 18407608BACKGROUND

  • McOmber MA, Shulman RJ. Pediatric functional gastrointestinal disorders. Nutr Clin Pract. 2008 Jun-Jul;23(3):268-74. doi: 10.1177/0884533608318671.

    PMID: 18595859BACKGROUND

  • Shulman RJ, Eakin MN, Czyzewski DI, Jarrett M, Ou CN. Increased gastrointestinal permeability and gut inflammation in children with functional abdominal pain and irritable bowel syndrome. J Pediatr. 2008 Nov;153(5):646-50. doi: 10.1016/j.jpeds.2008.04.062. Epub 2008 Jun 9.

    PMID: 18538790BACKGROUND

  • Boonma P, Shapiro JM, Hollister EB, Badu S, Wu Q, Weidler EM, Abraham BP, Devaraj S, Luna RA, Versalovic J, Heitkemper MM, Savidge TC, Shulman RJ. Probiotic VSL#3 Treatment Reduces Colonic Permeability and Abdominal Pain Symptoms in Patients With Irritable Bowel Syndrome. Front Pain Res (Lausanne). 2021 Sep 22;2:691689. doi: 10.3389/fpain.2021.691689. eCollection 2021.

    PMID: 35295488DERIVED

Related Links

MeSH Terms

Conditions

Irritable Bowel SyndromeAbdominal PainDiarrhea

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Robert J Shulman, M.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 4, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

US(2)