Trial Outcomes & Findings for Dietary Treatment of Crohn's Disease (NCT NCT00343642)
NCT ID: NCT00343642
Last Updated: 2021-06-09
Results Overview
The efficacy of the dietary treatment was assessed by looking at the number of participants who flared.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2021-06-09
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 milestones
| Measure |
Time and Attention and Active Fructo-oligosaccharide
Subjects received an active prebiotic fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans
|
Time and Attention and Fructo-oligosaccharide Placebo
Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.
|
Dietary Therapy and Fructo-oligosaccharide Placebo
Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
16
|
|
Overall Study
Upto 3 Months Complete or Flare
|
2
|
0
|
1
|
|
Overall Study
3-6 Months Complete or Flare
|
4
|
2
|
2
|
|
Overall Study
COMPLETED
|
10
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
7
|
Reasons for withdrawal
| Measure |
Time and Attention and Active Fructo-oligosaccharide
Subjects received an active prebiotic fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans
|
Time and Attention and Fructo-oligosaccharide Placebo
Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.
|
Dietary Therapy and Fructo-oligosaccharide Placebo
Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
4
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Flare up
|
6
|
4
|
0
|
Baseline Characteristics
Dietary Treatment of Crohn's Disease
Baseline characteristics by cohort
| Measure |
Time and Attention + Active Fructooligosaccharide Supplement.
n=19 Participants
Time and attention + active fructooligosaccharide supplement.
Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily
|
Time and Attention + Fructooligosaccharide Placebo
n=19 Participants
Time and attention + fructooligosaccharide placebo
Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily
|
Dietary Therapy + Fructooligosaccharide Placebo
n=16 Participants
Dietary therapy + fructooligosaccharide placebo
dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Continuous
|
43.21 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
48 years
STANDARD_DEVIATION 16.89 • n=7 Participants
|
45.13 years
STANDARD_DEVIATION 14.17 • n=5 Participants
|
45.46 years
STANDARD_DEVIATION 14.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
16 participants
n=5 Participants
|
54 participants
n=4 Participants
|
|
Smoking
Smokers
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Smoking
Non-smokers
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
16 participants
n=5 Participants
|
50 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsThe efficacy of the dietary treatment was assessed by looking at the number of participants who flared.
Outcome measures
| Measure |
Time and Attention + Active Fructooligosaccharide Supplement
n=19 Participants
Time and attention + active fructooligosaccharide supplement.
Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily
|
Time and Attention + Fructooligosaccharide Placebo
n=19 Participants
Time and attention + fructooligosaccharide placebo
Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily
|
Dietary Therapy + Fructooligosaccharide Placebo
n=16 Participants
Dietary therapy + fructooligosaccharide placebo
dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder
|
|---|---|---|---|
|
Number of Participants With Flare Up of Crohn's Disease Through Month 12
|
6 participants
|
4 participants
|
0 participants
|
PRIMARY outcome
Timeframe: At exit visit of studyInflammatory 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.
Outcome measures
| Measure |
Time and Attention + Active Fructooligosaccharide Supplement
n=19 Participants
Time and attention + active fructooligosaccharide supplement.
Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily
|
Time and Attention + Fructooligosaccharide Placebo
n=19 Participants
Time and attention + fructooligosaccharide placebo
Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily
|
Dietary Therapy + Fructooligosaccharide Placebo
n=16 Participants
Dietary therapy + fructooligosaccharide placebo
dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder
|
|---|---|---|---|
|
Quality of Life in Patients Taking Dietary Treatments
|
180.17 units on a scale
Standard Deviation 24.78
|
197.42 units on a scale
Standard Deviation 22.55
|
196 units on a scale
Standard Deviation 18.52
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Data not Collected
Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected
Data not collected
Outcome measures
Outcome data not reported
Adverse Events
Time and Attention + Active Fructooligosaccharide Supplement.
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Time and Attention + Fructooligosaccharide Placebo
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Dietary Therapy + Fructooligosaccharide Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Time and Attention + Active Fructooligosaccharide Supplement.
n=19 participants at risk
Time and attention + active fructooligosaccharide supplement.
Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily
|
Time and Attention + Fructooligosaccharide Placebo
n=19 participants at risk
Time and attention + fructooligosaccharide placebo
Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily
|
Dietary Therapy + Fructooligosaccharide Placebo
n=16 participants at risk
Dietary therapy + fructooligosaccharide placebo
dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/19 • 1 year
|
0.00%
0/16 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Crohn's flare up
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/19 • 1 year
|
0.00%
0/16 • 1 year
|
Other adverse events
| Measure |
Time and Attention + Active Fructooligosaccharide Supplement.
n=19 participants at risk
Time and attention + active fructooligosaccharide supplement.
Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily
|
Time and Attention + Fructooligosaccharide Placebo
n=19 participants at risk
Time and attention + fructooligosaccharide placebo
Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily
|
Dietary Therapy + Fructooligosaccharide Placebo
n=16 participants at risk
Dietary therapy + fructooligosaccharide placebo
dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder
|
|---|---|---|---|
|
Cardiac disorders
Cardio vascular and Pulmonary symptoms
|
57.9%
11/19 • Number of events 13 • 1 year
|
47.4%
9/19 • Number of events 11 • 1 year
|
50.0%
8/16 • Number of events 14 • 1 year
|
|
Endocrine disorders
Endocrine signs and symptoms
|
0.00%
0/19 • 1 year
|
15.8%
3/19 • Number of events 4 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Immune system disorders
Allergy symptoms
|
15.8%
3/19 • Number of events 6 • 1 year
|
26.3%
5/19 • Number of events 6 • 1 year
|
25.0%
4/16 • Number of events 8 • 1 year
|
|
Cardiac disorders
Abnormal Heart exam
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
18.8%
3/16 • Number of events 4 • 1 year
|
|
General disorders
Tooth issues
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell skin cancer
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/19 • 1 year
|
0.00%
0/16 • 1 year
|
|
Renal and urinary disorders
GenitoUrinary symptoms
|
15.8%
3/19 • Number of events 8 • 1 year
|
15.8%
3/19 • Number of events 8 • 1 year
|
25.0%
4/16 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fractures
|
0.00%
0/19 • 1 year
|
10.5%
2/19 • Number of events 2 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
Fever
|
31.6%
6/19 • Number of events 8 • 1 year
|
21.1%
4/19 • Number of events 4 • 1 year
|
18.8%
3/16 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Abnormal exam due to URI
|
26.3%
5/19 • Number of events 6 • 1 year
|
36.8%
7/19 • Number of events 9 • 1 year
|
0.00%
0/16 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint pain/ MSK problems
|
63.2%
12/19 • Number of events 31 • 1 year
|
36.8%
7/19 • Number of events 29 • 1 year
|
56.2%
9/16 • Number of events 21 • 1 year
|
|
Gastrointestinal disorders
Infection- GI
|
0.00%
0/19 • 1 year
|
0.00%
0/19 • 1 year
|
12.5%
2/16 • Number of events 3 • 1 year
|
|
Nervous system disorders
Neurological symptoms
|
63.2%
12/19 • Number of events 18 • 1 year
|
63.2%
12/19 • Number of events 17 • 1 year
|
37.5%
6/16 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1 • 1 year
|
26.3%
5/19 • Number of events 10 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Infection- URI
|
68.4%
13/19 • Number of events 31 • 1 year
|
47.4%
9/19 • Number of events 15 • 1 year
|
56.2%
9/16 • Number of events 20 • 1 year
|
|
General disorders
Nausea/Vomitting
|
47.4%
9/19 • Number of events 16 • 1 year
|
21.1%
4/19 • Number of events 4 • 1 year
|
25.0%
4/16 • Number of events 4 • 1 year
|
|
Eye disorders
Eye symptoms
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 2 • 1 year
|
18.8%
3/16 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Abnormal abdominal exam
|
42.1%
8/19 • Number of events 19 • 1 year
|
47.4%
9/19 • Number of events 20 • 1 year
|
25.0%
4/16 • Number of events 9 • 1 year
|
|
General disorders
Extraintestinal Symptoms of IBD other than arthritis /arthralgia
|
5.3%
1/19 • Number of events 1 • 1 year
|
15.8%
3/19 • Number of events 5 • 1 year
|
25.0%
4/16 • Number of events 6 • 1 year
|
|
Psychiatric disorders
Psychiatric symptoms
|
21.1%
4/19 • Number of events 4 • 1 year
|
36.8%
7/19 • Number of events 9 • 1 year
|
25.0%
4/16 • Number of events 6 • 1 year
|
|
Renal and urinary disorders
Infection-UTI
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 3 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
GERD symptoms
|
26.3%
5/19 • Number of events 6 • 1 year
|
31.6%
6/19 • Number of events 8 • 1 year
|
0.00%
0/16 • 1 year
|
|
Infections and infestations
Infection-Lip Herpes
|
10.5%
2/19 • Number of events 2 • 1 year
|
0.00%
0/19 • 1 year
|
0.00%
0/16 • 1 year
|
|
Infections and infestations
Infection- HPV
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Diarrhea/Frequent BM
|
52.6%
10/19 • Number of events 14 • 1 year
|
31.6%
6/19 • Number of events 9 • 1 year
|
43.8%
7/16 • Number of events 8 • 1 year
|
|
Gastrointestinal disorders
Perianal and Rectal pain/discomfort
|
0.00%
0/19 • 1 year
|
21.1%
4/19 • Number of events 7 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
|
Infections and infestations
Infection- Cellulitis
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Infections and infestations
Infection- Shingles
|
5.3%
1/19 • Number of events 1 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal discomfort+pain
|
68.4%
13/19 • Number of events 57 • 1 year
|
68.4%
13/19 • Number of events 34 • 1 year
|
68.8%
11/16 • Number of events 37 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
26.3%
5/19 • Number of events 6 • 1 year
|
10.5%
2/19 • Number of events 3 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection- Genital
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/19 • 1 year
|
0.00%
0/16 • 1 year
|
|
Surgical and medical procedures
Surgeries
|
0.00%
0/19 • 1 year
|
15.8%
3/19 • Number of events 5 • 1 year
|
0.00%
0/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin lesions
|
52.6%
10/19 • Number of events 14 • 1 year
|
36.8%
7/19 • Number of events 11 • 1 year
|
43.8%
7/16 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Decrease in Appetite
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/19 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
Fatigue
|
52.6%
10/19 • Number of events 13 • 1 year
|
21.1%
4/19 • Number of events 9 • 1 year
|
12.5%
2/16 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Gas/Flatus
|
36.8%
7/19 • Number of events 14 • 1 year
|
42.1%
8/19 • Number of events 11 • 1 year
|
31.2%
5/16 • Number of events 7 • 1 year
|
|
Renal and urinary disorders
Kidney Stone
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Rectal Bleeding
|
15.8%
3/19 • Number of events 4 • 1 year
|
5.3%
1/19 • Number of events 2 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
Weight Decline
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 2 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Change in bowel habits
|
10.5%
2/19 • Number of events 3 • 1 year
|
10.5%
2/19 • Number of events 2 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Urgency - Bowel
|
5.3%
1/19 • Number of events 1 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
18.8%
3/16 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Cardiac disorders
Hypertension
|
5.3%
1/19 • Number of events 1 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Tenesmus
|
5.3%
1/19 • Number of events 1 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Hernia - abdominal
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/19 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.3%
1/19 • Number of events 1 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
General disorders
Weight Gain
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/19 • 1 year
|
0.00%
0/16 • 1 year
|
|
Ear and labyrinth disorders
Abnormal ear exam
|
15.8%
3/19 • Number of events 4 • 1 year
|
0.00%
0/19 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Infections and infestations
Abscess
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Portal Hypertension
|
0.00%
0/19 • 1 year
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
5.3%
1/19 • Number of events 1 • 1 year
|
0.00%
0/19 • 1 year
|
0.00%
0/16 • 1 year
|
Additional Information
Ece A Mutlu, Principal Investigator
Rush University Medical Center
Phone: 312 942 5861
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place