Safety Study of Probiotics in Adults With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Phase I, Open Label Safety Study of VSL#3 in Adults With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971711
• Other study ID #: 24041
• Secondary ID: R01NR00533700533
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2009
• Last updated: March 4, 2016
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: March 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Recent studies performed outside the U.S. and/or prior to recent FDA requirements suggest that the probiotics in VSL#3 may be effective in IBS in adults. Because there is a significant unmet need for improved IBS therapies to prevent frequent exacerbations that lead to unscheduled health care, we will conduct a safety study of the probiotic VSL#3. Preliminary studies suggest that probiotics such as VSL#3 are effective in the treatment of adults with IBS but safety studies have not been carried out. A safety study of VSL#3 has been carried out in adult asthmatics that demonstrated no significant adverse effects. Before a trial of VSL#3 can be performed in children with IBS, the FDA has requested that a safety trial be conducted in adults with IBS.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	Baylor Clinic	Houston	Texas
United States	Univerisity of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Nursing Research (NINR), University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

McOmber ME, Shulman RJ. Recurrent abdominal pain and irritable bowel syndrome in children. Curr Opin Pediatr. 2007 Oct;19(5):581-5. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		Daily for 4 or 8 weeks of treatment and 1 month after treatment	Yes
Secondary	Pain and Stooling Improvement		4 or 8 weeks of treatment and 1 month after treatment	No

External Links

•   Clinical Trial For Children with Irritable Bowel Syndrome
•   Information about Irritable Bowel Syndrome
•   Information about the Digestive System