Inflammatory Bowel DiseasesIBD-AIDNCT04757181
The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)
A study testing The IBD-AID in people with Inflammatory Bowel Diseases, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this study is to prospectively test the hypothesis that specific dietary modification can improve patient symptoms by promoting beneficial changes in the composition of the microbiome that, in turn, alter the immune response in such a way as to and ameliorate inflammatory conditions such as Inflammatory… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- The IBD-AID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Jun 2019
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - 15 years of age or older
- Willingness and capacity to significantly change diet
- Willing and able to comply with scheduled visits, blood, and stool collection, and other study procedures and to complete the study
- Clinical provider (GI clinician) permission for IBD patients to participate in the intervention is required for participation in the study.
- Evidence of personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- For children age 15 and above, the assent of the child and consent of a parent or legal guardian will be required.
Show all 9Show fewer
- One of the following:
- diagnosis of IBD, specifically Crohn's Disease and Ulcerative Colitis
- healthy control
Who cannot join
- the presence of infection (such as C.diff) precipitating the colitis
- antibiotics taken within 3 months of study entry
- medically unstable to give consent
- on heparin or Coumadin
- Prisoners
- Subjects who do not speak or understand English, to ensure that there is consistency in teaching and educational materials.
- Subjects who self-report current pregnancy
- Patients who do not receive clinical care at UMass Memorial Health Care
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Influence of Diet on Microbiome and Inflammation
The goal of this study is to prospectively test the hypothesis that specific dietary modification can improve patient symptoms by promoting beneficial changes in the composition of the microbiome that, in turn, alter the immune response in such a way as to and ameliorate inflammatory conditions such as Inflammatory Bowel Disease (IBD). The potential long term benefit of this research is a validated set of efficacious dietary guidelines for persons with IBD. The potential immediate benefit to patients is symptomatic relief and healing.
Read the detailed description
The gut microbiome is the community of microbes that inhabit the gastrointestinal tract. Sequencing and analysis of the DNA and/or RNA of the gut microbiome (metagenomics) allow the identification of the species present and assess the metabolic activities they carry out. Stools are largely microbial and the metagenomics of stool can provide insights into the functioning of the gut microbiome.
Nutrient processing by the gut microbiome is fundamental to energy extraction and immune response. Until recently, investigation of nutritional approaches to treating Inflammatory bowel diseases (IBD) has been largely limited to the use of enteral and total parenteral nutrition with the aim of providing bowel rest.
The IBD Anti-inflammatory diet (IBD-AID) was developed to establish a dietary therapy to address nutritional adequacy and malabsorption issues, promote symptom relief, and assist with remission. The IBD-AID has been designed to favor colonic bacteria that degrade dietary fibers and produce short-chain fatty acids (SCFAs). SCFAs regulate the production of cytokines (TNF-α, IL-2, IL-6, and IL-10), eicosanoids, and chemokines (e.g., MCP-1 and CINC-2) by acting on macrophages and endothelial cells. High levels of SCFAs then promote a hyporesponsive immunological environment to commensal bacteria through the down-regulation of those pro-inflammatory effectors, aiding homeostasis maintenance.
This diet utilizes foods that are available in most grocery stores and is intended to be a complete diet that provide balanced nutrition. As many of the available medical treatments for inflammatory bowel disease have risks, this diet may be a safer alternative to medical treatment in this population. The nutrition recommendations are safe. Diet modification poses minimal risk.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- The IBD-AID
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The IBD-AIDOther
Subjects will meet with study personnel for to fill out baseline questionnaires (approximately a 1-hour visit). Subjects will be instructed to make dietary changes based one the IBD-AID guidelines. Dietary instruction will be delivered via individual and group sessions led by trained study personnel. Participants will be expected to learn the skills of dietary change to the IBD-AID and will begin their 8 weeks compliance period followed by endpoint measures. Participants are encouraged to attend 3 cooking classes (1.5 hours duration) in our teaching kitchen.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Experimental | IBD patients will be used as their own control. Participants will start the study in a baseline phase (4 weeks) and intervention phase (8 weeks) Receives: Other: The IBD-AID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome change after the IBD-AID
Analysis of the microbial composition of the gut and changes that correlate with diet compliance
Measured: 8 weeks
Secondary outcomes (2)
Improvement of symptoms
Assessment of disease severity and overall quality of life before and after the IBD-AID
Measured: 8 weeks
Improvement of inflammatory markers
Assessment of inflammatory markers in blood before and after the IBD-AID
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Feb 2017
- Primary completion1 Feb 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study design is a single-arm, prospective, pre-post intervention trial.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Maldonado-Contreras, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757181
- Sponsor's protocol ID
- H00008033
- Acronym
- IBD-AID
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2021
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Diet on Microbiome and Inflammation
- ClinicalTrials.gov ID
- NCT04757181
- Acronym / sponsor ID
- IBD-AID / H00008033
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 17 Feb 2021 (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.
The goal of this study is to prospectively test the hypothesis that specific dietary modification can improve patient symptoms by promoting beneficial changes in the composition of the microbiome that, in turn, alter the immune response in such a way as to and ameliorate inflammatory conditions such as Inflammatory Bowel Disease (IBD). The potential long term benefit of this research is a validated set of efficacious dietary guidelines for persons with IBD. The potential immediate benefit to patients is symptomatic relief and healing.
Detailed description
The gut microbiome is the community of microbes that inhabit the gastrointestinal tract. Sequencing and analysis of the DNA and/or RNA of the gut microbiome (metagenomics) allow the identification of the species present and assess the metabolic activities they carry out. Stools are largely microbial and the metagenomics of stool can provide insights into the functioning of the gut microbiome.
Nutrient processing by the gut microbiome is fundamental to energy extraction and immune response. Until recently, investigation of nutritional approaches to treating Inflammatory bowel diseases (IBD) has been largely limited to the use of enteral and total parenteral nutrition with the aim of providing bowel rest.
The IBD Anti-inflammatory diet (IBD-AID) was developed to establish a dietary therapy to address nutritional adequacy and malabsorption issues, promote symptom relief, and assist with remission. The IBD-AID has been designed to favor colonic bacteria that degrade dietary fibers and produce short-chain fatty acids (SCFAs). SCFAs regulate the production of cytokines (TNF-α, IL-2, IL-6, and IL-10), eicosanoids, and chemokines (e.g., MCP-1 and CINC-2) by acting on macrophages and endothelial cells. High levels of SCFAs then promote a hyporesponsive immunological environment to commensal bacteria through the down-regulation of those pro-inflammatory effectors, aiding homeostasis maintenance.
This diet utilizes foods that are available in most grocery stores and is intended to be a complete diet that provide balanced nutrition. As many of the available medical treatments for inflammatory bowel disease have risks, this diet may be a safer alternative to medical treatment in this population. The nutrition recommendations are safe. Diet modification poses minimal risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study design is a single-arm, prospective, pre-post intervention trial.
| Arm | Type | Receives |
|---|---|---|
| IBD patients | Experimental | Other: The IBD-AIDIBD patients will be used as their own control. Participants will start the study in a baseline phase (4 weeks) and intervention phase (8 weeks) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- - 15 years of age or older
- Willingness and capacity to significantly change diet
- Willing and able to comply with scheduled visits, blood, and stool collection, and other study procedures and to complete the study
- Clinical provider (GI clinician) permission for IBD patients to participate in the intervention is required for participation in the study.
- Evidence of personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Key exclusion criteria (8 listed)
- the presence of infection (such as C.diff) precipitating the colitis
- antibiotics taken within 3 months of study entry
- medically unstable to give consent
- on heparin or Coumadin
- Prisoners
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 |
|---|---|---|
| The IBD-AIDSubjects will meet with study personnel for to fill out baseline questionnaires (approximately a 1-hour visit). Subjects will be instructed to make dietary changes based one the IBD-AID guidelines. Dietary instruction will be delivered via individual and group sessions led by trained study personnel. Participants will be expected to learn the skills of dietary change to the IBD-AID and will begin their 8 weeks compliance period followed by endpoint measures. Participants are encouraged to attend 3 cooking classes (1.5 hours duration) in our teaching kitchen. | Other | IBD patients |
Primary outcome
Microbiome change after the IBD-AID
Time frame: 8 weeks
Analysis of the microbial composition of the gut and changes that correlate with diet compliance
2 secondary outcomes
Improvement of symptoms
Time frame: 8 weeks
Improvement of inflammatory markers
Time frame: 8 weeks
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 21 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The IBD-AID in people with Inflammatory Bowel Diseases, run by University of Massachusetts, Worcester at 1 site 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 9 inclusion and 8 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Microbiome change after the IBD-AID (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.