Crohn's DiseasePhase 1/2NCT00343642
Dietary Treatment of Crohn's Disease
A Phase 1/2 study testing Active fructo-oligosaccharide and Diet in people with Crohn's Disease and Inflammatory Bowel Disease, run by Rush University Medical Center at 2 sites in United States.
Trial summary
Our objective is to determine whether a specific dietary intervention or a fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it is beneficial in the treatment of Crohn's Disease (CD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease, Inflammatory Bowel Disease
- What is being tested?
- Active fructo-oligosaccharide and Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Oct 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented ileocolonic or colonic CD based on classical history and classical endoscopic or surgical findings and histology compatible with CD;
- Induction of remission with medical therapy within 9 months of the study;
- Inactive CD for at least 2 weeks with CDAI score less than 150;
- No change in IBD medication doses for 3 months;
- No change in smoking habits a month prior to enrollment (because smoking may exacerbate CD) and acceptance of not-changing smoking habits during the term of the study).
Who cannot join
- Patients with history of bowel obstruction and/or known strictures (as the high fiber content may precipitate obstruction);
- Patients with extensive colonic or ileocolonic resection;
- Patients with ileostomies or colostomies with diverted fecal stream;
- Patients with isolated perianal/anorectal disease;
- Patients with surgically induced remission;
- Concomitant infection (e.g., C. difficile colitis);
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- Use of antibiotics within 4 weeks, or steroids, herbal remedies or diet therapies within 2 weeks of the onset of the trial or during the study;
- Use of potential IBD exacerbators such as NSAIDs within 1 wk of the study;
- Acute illness requiring immediate hospitalization for CD or other reasons;
- Presence of symptomatic organic GI disease other than CD, hemorrhoids, hiatal hernia; GERD;
- Pre-existent organ failure or severe comorbidities as these may change Gl flora:
- Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X> normal);
- Kidney disease (creatinine>2.0 mg/dL);
- Uncontrolled psychiatric illness;
- Clinically important lung disease or heart failure;
- HIV disease;
- Alcoholism;
- Transplant recipients;
- Patients receiving other immunosuppressant medications for comorbidities (e.g. Enbrel for rheumatoid arthritis);
- Presence of short bowel syndrome or severe malnutrition with ideal body weight less than or equal to 90% or predicted;
- Estimated survival <1 year and Karnofsky performance status <50%;
- Desire to become pregnant during study or current pregnancy or nursing;
- Desire to change smoking-status during the study;
- Daily use of anticoagulation and antiplatelet medications;
- Complicated IBD with anticipation of imminent surgical intervention during the term of the study;
- Inability to have a regular follow-up and comply with study requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201
About this study
Our objective is to determine whether a specific dietary intervention or a fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it is beneficial in the treatment of Crohn's Disease (CD.
Read the detailed description
Several epidemiological studies and therapeutic observations in the complementary and alternative medicine (CAM) literature suggest that diet is key to development of CD and its treatment. The investigators took advantage of these CAM recommendations and designed dietary interventions. Our preliminary open label studies in IBD patients showed that our interventions are acceptable and well-tolerated and result in improvement, reducing symptoms and/or the degree of inflammation. The investigators are now seeking to validate this finding and determine the mechanisms underlying the effects of dietary manipulation-such as potential effects on colonic bacterial microflora. In another pilot study using 16s rDNA bacterial fingerprinting, the investigators demonstrated that the intestinal microflora of patients with CD differ significantly from healthy individuals. Whether the investigators can normalize/change the microflora of CD patients with dietary therapies, however, remains to be determined. Accordingly, the investigators designed a double blind placebo controlled study to test the hypotheses that: (1) dietary manipulation with either diet or a FOS supplement is an effective CAM therapy that prevents CD relapse (leads to maintenance of remission) and (2) such dietary manipulation can normalize the microflora of CD patients and decrease mucosal oxidative damage.
90 participants are expected to undergo the trial and have a 2:1 chance of receiving active therapy. The trial is seeking to enroll participants with inactive CD who have been medically induced into remission within 9 months of enrollment. Participants must be on their Crohn's medications at a stable dose for 3 months, which does not include steroids (e.g. Prednisone, Entocort) or antibiotics at the time of enrollment. Participants will be followed till relapse occurs or up to 52 weeks. Participants are asked to fill out a variety of questionnaires, keep a food and adverse event diary, and have a research, limited, unprepped flexible sigmoidoscopy for colonic tissue collection at the beginning and end of the study period.
Significance. This study could provide information to suggest diet or dietary supplement as a safe therapy for IBD and lay the groundwork for more definitive, randomized, controlled trials.
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease
- Being tested
- Active fructo-oligosaccharide, Placebo fructo-oligosaccharide, Diet
- Keywords
- Crohn's disease, Fructooligosaccharide, Inulin, Diet, Treatment, Bacterial flora, Oxidative stress
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active fructo-oligosaccharideDrug
Also called Active fructooligosaccharide (FOS) and Placebo Diet, Time and Attention and Active Fructooligosaccharide
2 teaspoons of active fructo-oligosaccharides daily and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans
Placebo fructo-oligosaccharideDrug
Also called Placebo Diet and Placebo Supplement, Tiem and Attention and Fructooligosaccharide Placebo
2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily) and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans
DietDietary supplement
Also called Active Dietary Intervention and Placebo Supplement, Dietary Treatment and Fructooligosaccharide Placebo
A restrictive anti-inflammatory diet developed by the research team and 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily)
| Study group | Role | What they receive |
|---|---|---|
| Active Fructo-oligosaccharide | Experimental | Subjects received an active fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.
The fructo-oligosaccharide supplement was administered orally in a powder form two teaspoons daily. Receives: Drug: Active fructo-oligosaccharide |
| Placebo Fructo-oligosaccharide | Placebo comparator | Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans. Receives: Drug: Placebo fructo-oligosaccharide |
| Dietary Therapy | Active comparator | Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team. Receives: Dietary Supplement: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Flare Up of Crohn's Disease Through Month 12
The efficacy of the dietary treatment was assessed by looking at the number of participants who flared.
Measured: Up to 12 months
Quality of Life in Patients Taking Dietary Treatments
Inflammatory Bowel Disease Questionnaire (IBDQ) overall scores at the exit visit of the study.It consists of 32 questons divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.
Measured: At exit visit of study
Safety of Dietary Treatments
Data not collected
Measured: 90 days
Secondary outcomes (1)
Changes in Ileocolonic Flora
Data not collected
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startSep 2006
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Ece A Mutlu, MD MBA, Principal investigator, Rush University Medical CenterAli Keshavarzian, MD, Study director, Rush University Medical CenterShahriar Sedghi, MD, Study director, Gastroenterology Associates of Central Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343642
- Sponsor's protocol ID
- R21AT001628-01A2
- Other IDs
- R21AT001628-01A2
- Status last verified
- May 2021
- First submitted
- 21 Jun 2006
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Treatment of Crohn's Disease
- ClinicalTrials.gov ID
- NCT00343642
- Acronym / sponsor ID
- R21AT001628-01A2
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease
- Keywords
- Crohn's disease, Fructooligosaccharide, Inulin, Diet, Treatment, Bacterial flora, Oxidative stress
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Jun 2006 (estimated)
- Results
- Posted 9 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our objective is to determine whether a specific dietary intervention or a fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it is beneficial in the treatment of Crohn's Disease (CD.
Detailed description
Several epidemiological studies and therapeutic observations in the complementary and alternative medicine (CAM) literature suggest that diet is key to development of CD and its treatment. The investigators took advantage of these CAM recommendations and designed dietary interventions. Our preliminary open label studies in IBD patients showed that our interventions are acceptable and well-tolerated and result in improvement, reducing symptoms and/or the degree of inflammation. The investigators are now seeking to validate this finding and determine the mechanisms underlying the effects of dietary manipulation-such as potential effects on colonic bacterial microflora. In another pilot study using 16s rDNA bacterial fingerprinting, the investigators demonstrated that the intestinal microflora of patients with CD differ significantly from healthy individuals. Whether the investigators can normalize/change the microflora of CD patients with dietary therapies, however, remains to be determined. Accordingly, the investigators designed a double blind placebo controlled study to test the hypotheses that: (1) dietary manipulation with either diet or a FOS supplement is an effective CAM therapy that prevents CD relapse (leads to maintenance of remission) and (2) such dietary manipulation can normalize the microflora of CD patients and decrease mucosal oxidative damage.
90 participants are expected to undergo the trial and have a 2:1 chance of receiving active therapy. The trial is seeking to enroll participants with inactive CD who have been medically induced into remission within 9 months of enrollment. Participants must be on their Crohn's medications at a stable dose for 3 months, which does not include steroids (e.g. Prednisone, Entocort) or antibiotics at the time of enrollment. Participants will be followed till relapse occurs or up to 52 weeks. Participants are asked to fill out a variety of questionnaires, keep a food and adverse event diary, and have a research, limited, unprepped flexible sigmoidoscopy for colonic tissue collection at the beginning and end of the study period.
Significance. This study could provide information to suggest diet or dietary supplement as a safe therapy for IBD and lay the groundwork for more definitive, randomized, controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Fructo-oligosaccharide | Experimental | Drug: Active fructo-oligosaccharideSubjects received an active fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans. The fructo-oligosaccharide supplement was administered orally in a powder form two teaspoons daily. |
| Placebo Fructo-oligosaccharide | Placebo comparator | Drug: Placebo fructo-oligosaccharideSubjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans. |
| Dietary Therapy | Active comparator | Dietary Supplement: DietSubjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented ileocolonic or colonic CD based on classical history and classical endoscopic or surgical findings and histology compatible with CD;
- Induction of remission with medical therapy within 9 months of the study;
- Inactive CD for at least 2 weeks with CDAI score less than 150;
- No change in IBD medication doses for 3 months;
- No change in smoking habits a month prior to enrollment (because smoking may exacerbate CD) and acceptance of not-changing smoking habits during the term of the study).
Key exclusion criteria (26 listed)
- Patients with history of bowel obstruction and/or known strictures (as the high fiber content may precipitate obstruction);
- Patients with extensive colonic or ileocolonic resection;
- Patients with ileostomies or colostomies with diverted fecal stream;
- Patients with isolated perianal/anorectal disease;
- Patients with surgically induced remission;
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 |
|---|---|---|
| Active fructo-oligosaccharideAlso: Active fructooligosaccharide (FOS) and Placebo Diet, Time and Attention and Active Fructooligosaccharide2 teaspoons of active fructo-oligosaccharides daily and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans | Drug | Active Fructo-oligosaccharide |
| Placebo fructo-oligosaccharideAlso: Placebo Diet and Placebo Supplement, Tiem and Attention and Fructooligosaccharide Placebo2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily) and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans | Drug | Placebo Fructo-oligosaccharide |
| DietAlso: Active Dietary Intervention and Placebo Supplement, Dietary Treatment and Fructooligosaccharide PlaceboA restrictive anti-inflammatory diet developed by the research team and 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily) | Dietary supplement | Dietary Therapy |
Primary outcome
Number of Participants With Flare Up of Crohn's Disease Through Month 12
Time frame: Up to 12 months
The efficacy of the dietary treatment was assessed by looking at the number of participants who flared.
Quality of Life in Patients Taking Dietary Treatments
Time frame: At exit visit of study
Inflammatory Bowel Disease Questionnaire (IBDQ) overall scores at the exit visit of the study.It consists of 32 questons divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.
Safety of Dietary Treatments
Time frame: 90 days
Data not collected
1 secondary outcome
Changes in Ileocolonic Flora
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ece A Mutlu, MD MBA principal investigator
Rush University Medical Center
Ali Keshavarzian, MD study director
Rush University Medical Center
Shahriar Sedghi, MD study director
Gastroenterology Associates of Central Georgia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Active fructo-oligosaccharide and Diet in people with Crohn's Disease and Inflammatory Bowel Disease, run by Rush University Medical Center 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 5 inclusion and 26 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 9 Jun 2021. 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. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Flare Up of Crohn's Disease Through Month 12 (time frame: Up to 12 months). The study lists 3 primary outcomes in all. 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 9 Jun 2021.