Irritable Bowel SyndromeNCT03459482
Endpoint Determination Study Protocol
A study testing Food Elimination Diet in people with Irritable Bowel Syndrome, run by Biomerica at 8 sites in United States.
Trial summary
This study is designed to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Food Elimination Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 556 participants
- Where
- 8 sitesUnited States
- Study dates
- 21 Jun 2018to 31 Dec 2021
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years old or older.
- Able to read and understand English.
- Willing and able to sign the informed consent.
- Have access to a computer and/or cell phone access for Electronic Data Capture (EDC)
- Meets Rome IV Diagnostic Criteria for IBS
- Willing to follow a food elimination die
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- Well controlled diabetic patients; A1C <7.5 and stable medication (>3 months, NOT Metformin
- Score between ≥ 3 and <7.5 on the Abdominal Pain Intensity Assessment (IBS_API) based on a weekly average of worst daily (in past 24 hours) abdominal pain on a 0 to 10 point scale.
- Patients who are on stable (> 3 months) doses of medications or treatments for their IBS (e.g., probiotics, fiber, Viberzi, Linzess, Amitiza, Alosetron, Plecanatide, anticholinergics, antidepressants, Zofran bile acid sequestrants, or anti-diarrheals) will be allowed to continue their medications as long as no change in treatment is planned for the duration of the study and no dose adjustment is made during the duration of the study.
- A positive IgG antibody response for at least one food in the Biomerica InFoods® IBS panel
Who cannot join
- Unable to provide consent.
- Cannot use EDC system due to no cell phone and no computer access
- Does not qualify for a diagnosis of IBS by IV Diagnostic Criteria
- Diagnosed IBS, but an IBS-API score of <3.0 and >7.5
- Pregnant or breastfeeding
- Patients with diabetes currently on Metformin
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- Patients who have used Rifaximin in the past 3 months
- Patients engaged in another type of diet therapy, i.e. FODMAP
- Patients which physicians are anticipating starting a new medication, change in dosage, diet or other treatment for IBS during the study
- Chronic pain from other conditions besides IBS
- Current or previous use of narcotic medications within past 3 months
- History of prior GI surgery except for cholecystectomy or appendectomy.
- History with any of the following:
- Gastroparesis, Uncontrolled GERD, Anorexia/bulimia Celiac disease Crohn's disease, Ulcerative Colitis, Abdominal/gastro cancer(s), Malabsorption syndrome(s).
- History of any other relevant inter-current medical conditions that could interfere with their participation in the study or the objectives of the study
- History of psychosis, schizophrenia, mania, or major psychiatric illness needing hospitalization within the past 6 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109-5362
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Houston Methodist Research Institute
Houston, Texas, 77030
UT Health
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
Mayo Clinic
Scottsdale, Arizona, 85259
Family Medicine Specialists
Wauconda, Illinois, 60084
About this study
Official title: Endpoint Determination Study for An Antibody Guided Dietary Restriction Trial Using Biomerica InFoods® IBS Test in Patients With a Previous Diagnosis of Irritable Bowel Syndrome (IBS)
This study is designed to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product.
Read the detailed description
The objective of this Endpoint Determination Study is to address key elements regarding a proposed larger clinical study design:
- Comparing different potential primary outcome measures
- Demonstrating that an exclusionary diet as determined by elevated IgG levels using the Biomerica InFoods® IBS Test is associated with alleviation of IBS symptoms
- Demonstrating the ability to mask the sham diet
- Demonstrating the safety of the exclusionary diet
Subjects' diets will be based on the results of the Biomerica, InFoods® IBS Test.
Immunoglobulin G (IgG) levels above a certain threshold are considered a positive response against a specific food or foods. It is expected that severity of symptoms of IBS will decrease when foods that generate a positive immune response in the Biomerica InFoods® IBS test are eliminated from the diet of the IBS patient.
The Endpoint Determination Study format will be a double-blinded randomized controlled clinical study enrolling subjects at two trial sites within the United States and designed to evaluate the use of IgG antibody guided dietary restrictions, based on the Biomerica InFoods® IBS Test, in the management of patients diagnosed with Irritable Bowel Syndrome (IBS).
The 2 sites will enroll approximately equal numbers of subjects. The target for each site is a minimum of 30 subjects in each classification: IBS with diarrhea [IBS-D], IBS with constipation [IBS-C] and IBS mixed [IBS-M] for a minimum of 90 patients per site, 180 total subjects for this study.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Food Elimination Diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Elimination DietOther
Subjects asked to participate in a food elimination diet, either True or Sham to evaluate the effects on their IBS symptoms
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - True Food Elimination Diet | Experimental | Group 1 (experimental group): Subjects will be given an elimination diet based upon foods with a positive antibody profile in the Biomerica InFoods® IBS test. The elimination diet will also exclude any and all foods to which the subject has a known IgE allergy and foods the subject already currently eliminates. Receives: Other: Food Elimination Diet |
| Group 2 - Sham Food Elimination Diet | Sham comparator | Group 2 (control group): Subjects will be given a "Sham" elimination diet. The sham diet will eliminate the same number of foods but none of the actual foods to which the patient had a positive antibody profile in the Biomerica InFoods® IBS test. The sham diet will also eliminate any and all foods to which the subject has a known IgE allergy and foods the subject already currently eliminates. Receives: Other: Food Elimination Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the IBS-API - Abdominal Pain Intensity. The IBS-API is being assessed daily from enrollment (baseline) to study completion; total 10 weeks
Abdominal pain intensity will be measured daily using an 11-point (0-10) numeric rating scale (NRS) that asks subjects to rate their worst abdominal pain over the past 24-hours.
Measured: Daily for 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start21 Jun 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomerica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William D Chey, MD, Principal investigator, University of MichiganAnthony J Lembo, MD, Principal investigator, Beth Israel Deaconess Medical Center (Harvard)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459482
- Sponsor's protocol ID
- EPT-InF24-001
- Status last verified
- Aug 2024
- First submitted
- 20 Feb 2018
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available.
Publications
Singh P, Chey WD, Takakura W, Cash BD, Lacy BE, Quigley EMM, Randall CW, Lembo A. A Novel, IBS-Specific IgG ELISA-Based Elimination Diet in Irritable Bowel Syndrome: A Randomized, Sham-Controlled Trial. Gastroenterology. 2025 Jun;168(6):1128-1136.e4. doi: 10.1053/j.gastro.2025.01.223. Epub 2025 Jan 31.
PubMed 39894284
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endpoint Determination Study for An Antibody Guided Dietary Restriction Trial Using Biomerica InFoods® IBS Test in Patients With a Previous Diagnosis of Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT03459482
- Acronym / sponsor ID
- EPT-InF24-001
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- BiomericaIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product.
Detailed description
The objective of this Endpoint Determination Study is to address key elements regarding a proposed larger clinical study design:
- Comparing different potential primary outcome measures
- Demonstrating that an exclusionary diet as determined by elevated IgG levels using the Biomerica InFoods® IBS Test is associated with alleviation of IBS symptoms
- Demonstrating the ability to mask the sham diet
- Demonstrating the safety of the exclusionary diet
Subjects' diets will be based on the results of the Biomerica, InFoods® IBS Test.
Immunoglobulin G (IgG) levels above a certain threshold are considered a positive response against a specific food or foods. It is expected that severity of symptoms of IBS will decrease when foods that generate a positive immune response in the Biomerica InFoods® IBS test are eliminated from the diet of the IBS patient.
The Endpoint Determination Study format will be a double-blinded randomized controlled clinical study enrolling subjects at two trial sites within the United States and designed to evaluate the use of IgG antibody guided dietary restrictions, based on the Biomerica InFoods® IBS Test, in the management of patients diagnosed with Irritable Bowel Syndrome (IBS).
The 2 sites will enroll approximately equal numbers of subjects. The target for each site is a minimum of 30 subjects in each classification: IBS with diarrhea [IBS-D], IBS with constipation [IBS-C] and IBS mixed [IBS-M] for a minimum of 90 patients per site, 180 total subjects for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel Design
| Arm | Type | Receives |
|---|---|---|
| Group 1 - True Food Elimination Diet | Experimental | Other: Food Elimination DietGroup 1 (experimental group): Subjects will be given an elimination diet based upon foods with a positive antibody profile in the Biomerica InFoods® IBS test. The elimination diet will also exclude any and all foods to which the subject has a known IgE allergy and foods the subject already currently eliminates. |
| Group 2 - Sham Food Elimination Diet | Sham comparator | Other: Food Elimination DietGroup 2 (control group): Subjects will be given a "Sham" elimination diet. The sham diet will eliminate the same number of foods but none of the actual foods to which the patient had a positive antibody profile in the Biomerica InFoods® IBS test. The sham diet will also eliminate any and all foods to which the subject has a known IgE allergy and foods the subject already currently eliminates. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 21 years old or older.
- Able to read and understand English.
- Willing and able to sign the informed consent.
- Have access to a computer and/or cell phone access for Electronic Data Capture (EDC)
- Meets Rome IV Diagnostic Criteria for IBS
Key exclusion criteria (16 listed)
- Unable to provide consent.
- Cannot use EDC system due to no cell phone and no computer access
- Does not qualify for a diagnosis of IBS by IV Diagnostic Criteria
- Diagnosed IBS, but an IBS-API score of <3.0 and >7.5
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Elimination DietSubjects asked to participate in a food elimination diet, either True or Sham to evaluate the effects on their IBS symptoms | Other | Group 1 - True Food Elimination Diet, Group 2 - Sham Food Elimination Diet |
Primary outcome
Change in the IBS-API - Abdominal Pain Intensity. The IBS-API is being assessed daily from enrollment (baseline) to study completion; total 10 weeks
Time frame: Daily for 10 weeks
Abdominal pain intensity will be measured daily using an 11-point (0-10) numeric rating scale (NRS) that asks subjects to rate their worst abdominal pain over the past 24-hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Derived from this study: PubMed 39894284Singh P, Chey WD, Takakura W, Cash BD, Lacy BE, Quigley EMM, Randall CW, Lembo A. A Novel, IBS-Specific IgG ELISA-Based Elimination Diet in Irritable Bowel Syndrome: A Randomized, Sham-Controlled Trial. Gastroenterology. 2025 Jun;168(6):1128-1136.e4. doi: 10.1053/j.gastro.2025.01.223. Epub 2025 Jan 31.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William D Chey, MD principal investigator
University of Michigan
Anthony J Lembo, MD principal investigator
Beth Israel Deaconess Medical Center (Harvard)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Elimination Diet in people with Irritable Bowel Syndrome, run by Biomerica at 8 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 10 inclusion and 16 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in the IBS-API - Abdominal Pain Intensity. The IBS-API is being assessed daily from enrollment (baseline) to study completion; total 10 weeks (time frame: Daily for 10 weeks). 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 NCT03459482, which also lists 1 linked publication.
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 5 Aug 2024.