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Irritable Bowel SyndromePhase 1NCT00971711

Safety Study of Probiotics in Adults With Irritable Bowel Syndrome

A Phase 1 study testing Probiotic in people with Irritable Bowel Syndrome, run by Baylor College of Medicine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Probiotic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesUnited States
Study dates
Sep 2009to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Baylor Clinic

    Houston, Texas, 77030

  • Univerisity of Washington

    Seattle, Washington

Other trials in United States

About this study

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

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

Read the detailed 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.

Being tested
Probiotic
Keywords
IBS, irritable bowel syndrome, abdominal pain, urgency, bloating, diarrhea
Medical subject headings
Irritable Bowel Syndrome, Abdominal Pain, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticBiological

    Also called VSL#3

    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.

Study groups in NCT00971711
Study groupRoleWhat they receive
ProbioticExperimentalTo determine the safety and effectiveness of the probiotic VSL#3 in adults with irritable bowel syndrome (IBS).
Receives: Biological: Probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

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

Secondary outcomes (1)

  1. Pain and Stooling Improvement

    Measured: 4 or 8 weeks of treatment and 1 month after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00971711
Sponsor's protocol ID
24041
Other IDs
R01NR005337, 005337
Status last verified
Mar 2016
First submitted
2 Sep 2009
Last updated
8 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17255832

  • 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.

    PubMed 17222318

  • 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.

    PubMed 20357915

  • 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.

    PubMed 19254999

  • 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.

    PubMed 12942886

  • 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.

    PubMed 16581896

  • 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.

    PubMed 17885479

  • 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.

    PubMed 18407608

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

    PubMed 18595859

  • 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.

    PubMed 18538790

  • 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.

    PubMed 35295488

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Probiotic in people with Irritable Bowel Syndrome, run by Baylor College of Medicine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: Daily for 4 or 8 weeks of treatment and 1 month after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00971711, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.

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