University at Buffalo

Behavioral Medicine Clinic

 
 

IBS Outcome Study FAQs

IBSOS logo

What is a clinical research study?

What is the IBSOS clinical research study?

What is the purpose of IBSOS?

Why study non–drug treatments for IBS?

Why do people volunteer for research?

What are the potential benefits to participating in IBSOS?

What are the potential discomforts or risks of being a research subject?

What are the possible disadvantages of taking part in the study?

Who may be eligible to participate in the IBSOS study?

If I choose to participate in the IBSOS trial can I continue to take my usual IBS medication during the trial period?

Will I have to pay anything?

What does this study require?

What are the alternatives for treatment of IBS?

Who is funding this study?

If I volunteer, is there any way I can change my mind later?

Is IBSOS being conducted anywhere else?

Will my participation be kept confidential?

How can I find out about the results of this research?

How do I become a participant in the trial and who should I contact for further information?

What is a clinical research study?
A clinical research study is a way for finding answers to difficult scientific or health questions. For example, doctors may do a research study to find out if a new medicine helps improve eyesight. Clinical trials follow pre–defined protocols, which are detailed plans for conducting the study.


What is the IBSOS clinical research study?
The Irritable Bowel Syndrome Outcome Study (IBSOS) is a federally funded clinical study that tests the effectiveness of two types of drug–free treatments for adults with moderate to severe IBS. Additional study goals aim to understand the reasons why treatments relieve IBS symptoms, identify individuals for whom treatment is most effective, and track the durability of treatment gains over one year. All treatment featured in this study has been proven effective in previous clinical trials.


What is the purpose of IBSOS?
The purpose of the IBSOS research study is to evaluate the effectiveness of two types of drug–free treatments in relieving pain and bowel problems (diarrhea, constipation or both) in adults with IBS. All treatment featured in this study has been proven effective in previous clinical trials. Because it is not clear which of the treatments would be better for you, patients are assigned to one of the two treatments by a random process. Participants do not choose a treatment but are assigned by the virtual flip of a coin.


Why study non-drug treatments for IBS?
Unfortunately, there is no medical cure for IBS. The goal of this state–of–the–art treatment program is to help patients learn ways to control flare–ups and live more comfortably and productively. While a number of IBS drugs have been pulled off the market because of side effects, non–drug treatments featured in the IBSOS are regarded equally safe and effective in reducing IBS symptoms in severely affected IBS patients.


Why do people volunteer for research?
These are the most common reasons people give for participating in research:

  • Receiving a new treatment. Participants in a clinical trial gain access to new, state–of–the–art treatments before they are widely available. In addition, these cutting–edge treatments are generally free and administered by experts in the field.
  • Playing a more proactive role in controlling their health. By participating in a clinical trial, participants feel empowered over their health care.
  • Helping to advance the treatment of IBS. Patient participation helps increase our knowledge about treating IBS that can only be discovered in studies such as this.


What are the potential benefits to participating in IBSOS?
Exceptional care is taken in developing any treatment that is tested in a clinical research study. You can be assured that you will be given excellent, state–of–the–art care delivered by an experienced, caring group of doctors.

IBSOS participants receive:

  • Free diagnostic assessment
  • Free treatment
  • Payment for their time

Individuals with moderate to severe IBS who have undergone treatments featured in the IBSOS typically report significant reduction in the severity and impact of IBS symptoms.


What are the potential discomforts or risks of being a research subject?
It is impossible to eliminate every risk in testing a new treatment. However, unnecessary risks are avoided and many safeguards are built into the research to minimize the harm that might occur if patients have an unfavorable response to the treatment. A careful review process to protect the health of human subjects is conducted before a study is approved.


What are the possible disadvantages of taking part in the study?
Because this trial features non–drug treatment, potential side effects are few and generally minor. The biggest inconvenience is time required to complete assessment and clinic visits.


Who may be eligible to participate in the IBSOS study?
Specific criteria have been established to determine who is eligible to participate in this research study. These criteria are based on such factors as age, disease/condition, previous treatment history, and other medical conditions. You may be eligible to participate in this clinical study if you:

  • Suffer from IBS symptoms (abdominal pain associated with diarrhea, constipation or both)
  • Experience symptoms at least twice weekly
  • Are at least 18 years old
If you meet the above criteria, contact the Behavioral Medicine Clinic about participating in this important study.


If I choose to participate in the IBSOS trial can I continue to take my usual IBS medication during the trial period?
Yes. Patients are not required to stop any medical or dietary treatment for IBS while they are being treated. We only ask patients to notify us of what treatments they are taking, the medication dosages, and any changes to these treatments.


Will I have to pay anything?
No. There is no charge for pre–treatment assessment and those who qualify and choose to participate will receive treatment and follow–up assessment free of charge. All eligible subjects will be paid for their time and travel for completing post–treatment follow–up visits.


What does this study require?
You will first be asked some basic eligibility questions on the phone to see if you qualify for the IBSOS trial. If it is determined that you are eligible, you will be invited for a follow–up visit where a clinician will explain the plan for the trial (known as the protocol) in full detail. You will also undergo an assessment that will include a non–invasive examination conducted by a gastroenterologist who will confirm that you have IBS, a clinical interview, and completion of a set of standardized questionnaires about your health, symptoms, medical history, etc. Patients who qualify and are willing to proceed will be monitored for symptoms for four weeks before receiving treatment that is scheduled over 10 weeks. After treatment is over, patients will undergo follow–up assessment at regularly scheduled times.


What are the alternatives for treatment of IBS?
Currently there is no cure for IBS, only medications and dietary agents meant to control symptoms. Most treatments have unpleasant side effects and are limited in their ability to relieve the full range of symptoms of IBS. The non–drug treatments featured in the IBSOS trial are recognized as some of the most effective IBS treatments available to patients.


Who is funding this study?
This study is funded by the National Institute of Diabetes and Digestive and Kidney of the National Institutes of Health.


If I volunteer, is there any way I can change my mind later?
Yes. Although it is preferred that volunteers are committed to completing the study, volunteers are free to withdraw at any time.


Is IBSOS being conducted anywhere else?
Yes. Northwestern University (Chicago, IL) is participating in this study in conjunction with the University at Buffalo.


Will my participation be kept confidential?
Yes, your anonymity will be protected within the limits of the law. No medical information will be released to outside individuals without your written permission. No names are given when reports on trials are made to the scientific community.


How can I find out about the results of this research?
The results of the study will not be published until all of the participants have finished. A summary of the main findings will be provided to interested participants.


How do I become a participant in the trial and who should I contact for further information?
If you think you might be eligible for this study, call the IBSOS at 716–898–4458 or contact us online to see if you qualify for an evaluation.

Study participation is dependent on screening and eligibility criteria.