CompletedNCT00343642Updated Jun 9, 2021Results posted

Dietary Treatment of Crohn's Disease

A Phase 1/2 interventional study of Active fructo-oligosaccharide and Placebo fructo-oligosaccharide in Crohn's Disease and Inflammatory Bowel Disease, sponsored by Rush University Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-09.

Sponsored by Rush University Medical Center · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 73
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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 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 studied

Crohn's Disease
Inflammatory Bowel Disease

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Keywords

Crohn's disease
Fructooligosaccharide
Inulin
Diet
Treatment
Bacterial flora
Oxidative stress

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 73 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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);
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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 73 participants (actual)

Study arms

Experimental
Active Fructo-oligosaccharide
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.
Drug: Active fructo-oligosaccharide
Placebo comparator
Placebo Fructo-oligosaccharide
Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.
Drug: Placebo fructo-oligosaccharide
Active comparator
Dietary Therapy
Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.
Dietary Supplement: Diet

Interventions

DrugActive fructo-oligosaccharide
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
Also known as: Active fructooligosaccharide (FOS) and Placebo Diet, Time and Attention and Active Fructooligosaccharide
DrugPlacebo fructo-oligosaccharide
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
Also known as: Placebo Diet and Placebo Supplement, Tiem and Attention and Fructooligosaccharide Placebo
Dietary supplementDiet
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)
Also known as: Active Dietary Intervention and Placebo Supplement, Dietary Treatment and Fructooligosaccharide Placebo

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: At exit visit of study
Safety of Dietary Treatments
Data not collected
Time frame: 90 days

Secondary outcomes

Changes in Ileocolonic Flora
Data not collected
Time frame: 90 days

Results

Posted Jun 9, 2021

Limitations and caveats

Pilot study, Slow recruitment

Participant flow

54 subjects were randomized into a 12 month randomized, double blind, placebo controlled trial to test the efficacy of a specialized restrictive diet and a Fructo-oligosaccharide (FOS) supplement in maintenance of remission in patients with Crohn's disease (CD). Participants were recruited at Rush University, Chicago between Sept 2005-2012.

Participant flow — Overall Study
Milestone	Time and Attention and Active Fructo-oligosaccharide	Time and Attention and Fructo-oligosaccharide Placebo	Dietary Therapy and Fructo-oligosaccharide Placebo
Started	19	19	16
Upto 3 months complete or flare	2	0	1
3-6 months complete or flare	4	2	2
Completed	10	11	9
Not completed	9	8	7
Withdrew: Lost to follow-up	0	1	0
Withdrew: Pregnancy	1	0	2
Withdrew: Withdrawal by subject	2	3	4
Withdrew: Adverse event	0	0	1
Withdrew: Flare up	6	4	0

Outcome measures

PrimaryNumber 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.

Time frame:: Up to 12 months
Reported as:: Number · participants

Number of Participants With Flare Up of Crohn's Disease Through Month 12
participants	Time and Attention + Active Fructooligosaccharide Supplement	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo
Number of Participants With Flare Up of Crohn's Disease Through Month 12	6	4	0

PrimaryQuality 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.

Time frame:: At exit visit of study
Reported as:: Mean · units on a scale

Quality of Life in Patients Taking Dietary Treatments
units on a scale	Time and Attention and Active Fructooligosaccharide Supplement	Time and Attention and Fructo-oligosaccharide Placebo	Dietary Therapy and Fructooligosaccharide Placebo
Quality of Life in Patients Taking Dietary Treatments	180.17 ± 24.78	197.42 ± 22.55	196 ± 18.52

PrimarySafety of Dietary Treatments

Data not collected

Time frame:: 90 days

No measurements were reported for this outcome.

SecondaryChanges in Ileocolonic Flora

Data not collected

Time frame:: 90 days

No measurements were reported for this outcome.

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Time and Attention + Active Fructooligosaccharide Supplement.	—	2/19 (10.5%)	19/19 (100%)
Time and Attention + Fructooligosaccharide Placebo	—	1/19 (5.3%)	19/19 (100%)
Dietary Therapy + Fructooligosaccharide Placebo	—	0/16 (0%)	16/16 (100%)

Most frequent serious events

Most frequent serious events
Event	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo
SyncopeNervous system disorders	1/19	0/19	0/16
Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders	0/19	1/19	0/16
Crohn's flare upGastrointestinal disorders	1/19	0/19	0/16

Most frequent other events

Showing 10 of 51

Most frequent other events
Event	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo
Abdominal discomfort+painGastrointestinal disorders	13/19	13/19	11/16
Infection- URIRenal and urinary disorders	13/19	9/19	9/16
Joint pain/ MSK problemsMusculoskeletal and connective tissue disorders	12/19	7/19	9/16
Neurological symptomsNervous system disorders	12/19	12/19	6/16
Cardio vascular and Pulmonary symptomsCardiac disorders	11/19	9/19	8/16
Diarrhea/Frequent BMGastrointestinal disorders	10/19	6/19	7/16
Skin lesionsSkin and subcutaneous tissue disorders	10/19	7/19	7/16
FatigueGeneral disorders	10/19	4/19	2/16
Nausea/VomittingGeneral disorders	9/19	4/19	4/16
Abnormal abdominal examGastrointestinal disorders	8/19	9/19	4/16

Baseline characteristics

All participants were patients with Crohn's disease in remission.

Age, Categorical
Age, Categorical(Participants)	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo	Total
<=18 years	0	0	0	0
Between 18 and 65 years	17	16	14	47
>=65 years	2	3	2	7

Age, Continuous
Age, Continuous(years)	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo	Total
Mean	43.21 ± 12.43	48 ± 16.89	45.13 ± 14.17	45.46 ± 14.51

Sex: Female, Male
Sex: Female, Male(Participants)	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo	Total
Female	10	13	10	33
Male	9	6	6	21

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo	Total
Hispanic or Latino	0	5	0	5
Not Hispanic or Latino	19	14	16	49
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	1	0	1
Black or African American	4	2	4	10
White	15	16	12	43
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo	Total
United States	19	19	16	54

Smoking
Smoking(participants)	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo	Total
Smokers	3	1	0	4
Non-smokers	16	18	16	50

Study locations

2 sites

Gastroenterology Associates of Central Georgia
Macon, Georgia 31201, United States
Rush University Medical Center
Chicago, Illinois 60612, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00343642
Lead sponsor: Rush University Medical Center
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Responsible party: Sponsor
First posted: Jun 23, 2006
Start date: Sep 2006
Primary completion: Oct 2012
Completion: Oct 2012
Results posted: Jun 9, 2021
Last update: Jun 9, 2021

Study contacts

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

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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