Safety Study of Probiotics in Adults With Irritable Bowel Syndrome
NCT ID: NCT00971711
Last Updated: 2016-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2009-09-30
2013-12-31
Brief Summary
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Detailed Description
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Consent will be obtained from the subject.
Adults who meet the criteria for irritable bowel syndrome will be recruited and studied. They will have been diagnosed by an adult gastroenterologist.
During a baseline one week period, the subjects will keep a diary of pain episodes, pain severity, pain-induced interference with activity, and stooling pattern (i.e., pain/activity/stool diary).
Following the baseline period, the subjects will be randomized into either a 4 week or 8 week treatment period with the probiotic. The treatment will be open label. During the treatment period, subjects will keep the diary for pain and stooling habits and a daily record of symptoms (i.e., daily temperature monitoring).
At the end of the treatment period the pain/stool/activity diary will be repeated. Four weeks after the treatment period ends a follow-up phone call will be made to participants to check on their pain and stooling patterns.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Probiotic
To determine the safety and effectiveness of the probiotic VSL#3 in adults with irritable bowel syndrome (IBS).
Probiotic
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.
Interventions
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Probiotic
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to speak and understand English
* Telephone access
* IBS Severity Scale score of \>= 75
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of Washington
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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Robert Shulman, M.D.
Professor of Pediatrics
Principal Investigators
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Robert J Shulman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Baylor Clinic
Houston, Texas, United States
Univerisity of Washington
Seattle, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
McOmber MA, Shulman RJ. Pediatric functional gastrointestinal disorders. Nutr Clin Pract. 2008 Jun-Jul;23(3):268-74. doi: 10.1177/0884533608318671.
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.
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.
Related Links
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Clinical Trial For Children with Irritable Bowel Syndrome
Other Identifiers
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005337
Identifier Type: -
Identifier Source: secondary_id
24041
Identifier Type: -
Identifier Source: org_study_id
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