Current IBS Studies

Here are ways that you can help advance research – in person or from the comfort of your home. Take part in these studies.


A Randomized, Double-Blind, Technology-Enabled Trial to Evaluate the Impact of a Multi-Strain Synbiotic (DS-01) on Metagenomic Stability and Metabolic Output of the Gut Microbiota.

Purpose of Study: This study aims to assess the impact of multi-strain consortia of 24 commensal organisms across 12 species with extensive strain-specific in vivo data, assessing a range of gastrointestinal symptoms without negatively altering the naive gut microbiota. High-throughput shotgun DNA sequencing will provide an opportunity for ‘-omics’-based analyses of the gut microbiota, which can be augmented by the metabolite profiles resulting from total microbial activity in the gut. Since many of these metabolites are bioeffector molecules acting upon the host, such analysis can provide a direct measure of the consequences of microbial activity in the gut and provide a novel integrated data set for patients with IBS. Recruited subjects will also use a smart-phone application to report day to day gastrointestinal symptoms, a patient-centric hallmark of this chronic gut condition.

Sponsor: Beth Israel Deaconess Medical Center

Condition: Irritable bowel Syndrome-Constipation (IBS-C) and Irritable Bowel Syndrome-Mixed (IBS-M)

Participation: 

  • Patient must be willing and able to give informed assent/ consent for participation in the study (see Section 15.2).
  • Patient must be willing and able (in the PI’s opinion) to comply with all study requirements.
  • Patient must be a premenopausal female aged 18 and older.
  • Patient must have a documented history of IBS that is not completely controlled by current IBS drugs.
  • Patient must have a score of ≥150 on the IBS-SSS at screening.
  • Patient must have no clinically relevant (in the judgment of the PI) abnormal blood laboratory levels at screening or randomization.
  • The clinician will assess eligibility as per the Rome IV criteria (Recurrent abdominal pain or discomfort at least 1 day/week in the last 3 months associated with two or more of the following: Improvement with defecation. Onset associated with a change in frequency of stool).

Study Contact: For more information, call Vivian Cheng, MS, MPH at (617)-667-0682, or Email: vcheng2@bidmc.harvard.edu

Added April 2021

Purpose of study: This study involves free nutrition sessions with a skilled IBS-specializing dietitian.

Sponsor: UCLA Oppenheimer Family Center for Neurobiology of Stress

Participation: Eligible male and female individuals ages 18 and older with a diagnosis of IBS with diarrhea or diarrhea with constipation (IBS-D or IBS-M). To participate, individuals must not have tried the low FODMAP diet before.

Contact: For more information, visit www.uclacns.org/patients/clinical-research or call (310) 206-1656. You may also email Nafessa Islam at NIslam@mednet.ucla.edu

Verified May 2018


Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

Purpose of study: The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.

Sponsor: Indiana University and NIDDK

Participation: Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.

Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.

Contact: For more information, visit clinicaltrials.gov/ 

Contact: Tonya Hamilton 317-278-9296 tpinksto@iu.edu
Contact: Anita Gupta 317-948-9227 ext 3179489227 anigupta@iu.edu

Added February 2020


Lactobacillus LB as Treatment for Irritable Bowel Syndrome With Predominance of Diarrhea (IBS-D)

Purpose of study: The combination of Lactobacillus fermentum and Lactobacillus delbrueckii (Lactobacillus LB) has proven to be effective and safe for treatment of acute diarrhea in children. Also, a clinical trial in adult patients with chronic diarrhea, showed a reduction in the number of daily stools. However, the evidence is not enough regarding the efficacy and safety of Lactobacillus LB for treatment of patients with irritable bowel syndrome with predominance of diarrhea (IBS-D).

Sponsor: Hospital General de Mexico

Participation: Patients meeting Rome IV criteria for IBS-D, without specific medical treatment for the last 4 weeks prior to inclusion in this study.

Contact: For more information, visit https://clinicaltrials.gov/ or email fatimahiguera@hotmail.com

Added February 2020


Purpose of study: The purpose of this study is to examine brain networks at rest in chronic pain conditions compared to healthy controls.

Sponsor: UCLA Oppenheimer Family Center for Neurobiology of Stress

Participation: Men and women between the ages of 18 and 55 who are diagnosed with IBS, right handed, not pregnant and no significant neurological or psychological medical history.

About the study: Participation involves a screening visit, an MRI and one stool sample.

Participants will be compensated up to $100 and get a digital picture of your brain.

Contact: For more information, visit www.uclacns.org/patients/clinical-research or call (310) 206-8545. You can also email Nafeesa Islam at NIslam@mednet.ucla.edu

Added May 2018


Effect of Tai Chi as Treatment for IBS-C

Purpose of study: The purpose of the study is to evaluate the efficacy of Tai Chi practice in reducing symptoms of Irritable Bowel Syndrome with Constipation (IBS-C).

Sponsor: Massachusetts General Hospital

Participation:

  • Age 18 – 65 years
  • BMI ≤ 35
  • Rome IV criteria for IBS-C
  • Continued IBS-C throughout run-in period
  • Compliant with reporting during run-in
  • Ability to follow verbal and written instructions
  • Ability to record daily patient reported outcomes via RedCap survey
  • Ability to use the GeoPain app on a smart phone
  • Informed consent form signed by the subjects

About the study:

This is a single-center pilot study investigating the efficacy of Tai Chi practice in reducing symptoms of IBS. The investigators hope that subjects practicing Tai Chi will have reduced symptoms of IBS-C as measured through overall global symptom relief as well as the IBS-SSS, IBS-QOL, VSI, HADS, Visual Analogue Pain Scale, and changes in bloating, abdominal pain, abdominal distention, and constipation severity. The study will also use daily entries made through the GeoPain app to record trends in pain intensity.

Contact: For more information, please visit: https://clinicaltrials.gov/ 

Contact: Mimi Paz, BA 617-643-5742 mpaz3@mgh.harvard.edu
Contact: Kyle Staller, MD, MPH 617-724-6038 kstaller@mgh.harvard.edu

Updated September 2020


A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing

Purpose of study: To provide treatment to patients with IBS-D.

Sponsor: University of Michigan and Michigan Institute for Clinical and Health Research (MICHR)

Participation: Men and women over the age of 18 diagnosed with IBS-D. Prior colonoscopy or sigmoidoscopy within the past 2 years with random colon biopsies to exclude the presence of microscopic colitis.

About the study: Patients will receive either rifaximin or low FODMAP dietary intervention.

Contact: For more information, visit https://clinicaltrials.gov/ct2/ or contact Dr. Allen Lee at (734) 936-9454, allenlee@umich.edu

Added May 2018


Participants Sought for Study on Complementary Approaches to the Treatment of IBS

Purpose of study: The purpose of this study is to find a complementary treatment to help Irritable Bowel Syndrome (IBS) patients in need of relief.

About The Study: The length of this study will be three weeks long, with a short online intervention everyday to help individuals deal with their body’s reactions to their environments. Participants will have additional surveys to assess their overall state at the beginning of the study, at the end of the three week intervention, and again at six weeks for a follow-up.

Participation: Eligible individuals between the ages of 18 – 65 years of age who are experiencing pain or discomfort associated with their gut. Cannot be smokers or have an inflammatory bowel disease.

How to Sign Up: http://bit.ly/IBS_study

There will be a $15 Target gift card for first 30 participants upon completion of study.

Study Contact: Jenna N. Ray,  Health Psychologist. Phone: (919) 257 – 7291, Email: jray51@uncc.edu

Verified August 2017


Canadian IBS and IBD Patients Needed for IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects) Study

Purpose of study: The overall aim of IMAGINE Network is to understand the interactions between diet-microbiome-host and find new therapies for the treatment of IBS, IBD and associated psychiatric disorders.

Develop innovative therapies (changes in diet, probiotics, fecal transplants or antibiotics) to improve IBD, IBS and mental health
Improve outcomes of existing therapies through the assessment of diet-microbiome-host interactions
Develop strategies to optimize current therapies to target those who will most benefit from medication as well as identify those in whom medication can be safely discontinued with significant personal benefit and cost savings to the Canadian healthcare system

About The Study: Transform the management of IBD and IBS and associated mental health issues with these disorders.

Sponsor: The IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects) Chronic Disease Network involves 17 hospitals/universities and 75 researchers across Canada who will study the interactions between the inflammation, microbiome, diet and mental health in patients with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS).  The IMAGINE Network is one of five chronic disease networks in the SPOR (Strategy for Patient Oriented Research) initiative of CIHR (Canadian Institutes of Health Research).

Participation: Persons from across Canada are being invited to participate in the IMAGINE Network. You may be eligible to participate in this study if you have been diagnosed by your physician with Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), including ulcerative colitis or Crohn’s disease or are a healthy individual without gastrointestinal symptoms.

You will not be eligible to participate if you have any of the following criteria:

Age under 4 years.
Past gastrointestinal bypass surgery or major bowel resections unrelated to Crohn’s disease.
Major concurrent illness such as chronic kidney disease, chronic liver disease other than primary sclerosing cholangitis, chronic immune disease unrelated to IBD.
If you have an active eating disorder such anorexia nervosa or bulimia.
If you cannot communicate in either French or English.

Due to the specific nature of this research, we require that participants have not had major gastrointestinal surgery (e.g. Roux en y, bowel resection), do not have additional disease(s) that might affect ability to participate (e.g. decompensated liver disease), prescription or non-prescription drug use that is known to cause gastrointestinal (GI) symptoms (e.g. chronic antibiotic use), fad diets or eating disorders that may cause GI symptoms.

Study Contact: Aida Fernandes, Executive Director fernaa19@mcmaster.ca or visit http://imaginespor.com/participate-in-research/

Added May 2020


Patients Needed for Endpoint Determination Study for Protocol 

Purpose of study: The objective of this Endpoint Determination Study is to address key elements regarding a proposed larger clinical study design. Subjects’ diet will be based on the results of Biomerica, InFoods IBS Test.

 

Sponsor: Biomerica 

Participation: 21 years of age or older that meets the criteria for IBS, and willing to follow a food elimination diet. 

Contacts: Viven Cheng 617-667-0682 vcheng2@bidmc.harvard.edu and Lina Nahlawi 734-936-2761 lnahlawi@med.umich.edu 

ClinicalTrials.gov identifier: NCT03459482

Added September 2018


Effect of Curcumin on Gut Microbiota in IBS

Purpose of study: To evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome (IBS) and to review any correlation between the changes in the microbiota with symptoms.

Sponsor: Medical College of Wisconsin

Participation

Inclusion Criteria:

10 to 18 years old
Fulfill the Rome IV criteria for diarrhea predominant IBS
English speaking
Able to swallow curcumin/placebo capsules
Exclusion Criteria:

Weigh less than 35 kg
On any form of dietary restrictions
Taken probiotics one month before enrollment
Antibiotic treatment one month before enrollment
IBD
Celiac disease
Peptic ulcer disease
H. Pylori gastritis
Abnormality of gastrointestinal tract
Previous abnormal endoscope
Previous abdominal surgeries
Gall stones
Biliary tract obstructions
Liver pathologies
Liver failure
Active GI infection
Positive stool cultures
Drug or alcohol abuse
Concomitant immunological/hematological/neoplastic/heart/ renal/pulmonary condition
Any other medical condition or taking any form of drug(s) which can explain the current symptoms
Take oral or intravenous drugs which could have potential drug interaction with curcumin
Lactating or pregnant or planning to become pregnant
Developmental delay
Parents that are developmentally delayed
Have a diet high in curcumin/turmeric

Contacts: Manu Sood msood@mcw.edu

ClinicalTrials.gov identifier: NCT03568513 

Added December 2019

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